Infertility services in Scotland (1993) - Scottish Government

scotland.gov.uk

Infertility services in Scotland (1993) - Scottish Government

INFERTILITY

SERVICES

IN SCOTLAND


00075009

SCOTTISH OFFICE LIBRARY SERVICE

ST. ANDREW'S HOUSE LIBRARY

Please return this book not later than the last date

stamped below

J3.

INFERTILITY

SERVICES

SCOTLAND

EDINBURGH HMSO


Crown copyright 1993

First published 1993

This report of a Working Group of the then National Medical

Committee was endorsed by the Scottish Health Service Plannin

commended to the Scottish Office Home and Health Departme

for the information of interested bodies and those concerned w

provision of services for the infertile.

The Secretary of State welcomes this report and accepts withou

the recommendations, except numbers 5, 8, 9, 16, 19 and 25, an

Boards to consider how they can be implemented. Recommend

are commended to Health Boards to be considered in the devel

infertility services and numbers 8 and 9 will be referred for furt

the CRAG advisory committee proposed in recommendation 27

Recommendation 25 has not been accepted. The Secretary of S

with colleagues in other parts of the UK, does not believe that

reproduction services meet the criteria for central NHS funding

Boards may provide or purchase Level III services if they wish

resources already allocated to them; the judgement of the prio

services, as compared with others, is for them to make.

ISBN 0 11 494267 6


It has been a great privilege to chair the Working Group of the National Medical

Consultative Committee (now known as the National Medical Advisory

Committee) on Infertility Services in Scotland. The Group's composition was

specifically designed to have a neutral chairman and to include gynaecologists who,

while distinguished in their own specialty, did not have a specific interest in

infertility. I have no doubt that this situation greatly assisted us in reaching our

findings in an objective and unbiased manner based upon the evidence of various

expert witnesses closely involved in the field.

During the preparation of this report, we were aware that a Study Group on The

Management of Gynaecological Services in Scotland, chaired by Dr George Forwell

and commissioned by the Scottish Health Service Planning Council, was running in

parallel. In order to avoid any confusion, it was arranged that there would be an

exchange of material between the 2 groups. In addition, it was agreed between Dr

Forwell and myself that the clinical aspects would be dealt with in this report and

cross-referenced by his Group while the management concerns would be covered

by his Group in the light of our recommendations.

It became clear to the Group that, apart from the very real personal and social

difficulties and the overwhelming sense of failure, infertility should be regarded as

a very real health problem for the affected couple. As such, and in the interests of

society as a whole, we have concluded that every involuntarily infertile couple

should be entitled, where they choose, to receive a proper and well-ordered

investigation leading, where possible, to diagnosis and treatment under the general

provision of the National Health Service. Logically, it is also clear that access to

rational treatment at all levels should be equally available. In the case of IVF and

GIFT, we do, however, feel there should be some limitation. Given our proposed

counselling facility at every stage of management, we are confident that patients in

the future will be more realistic in their expectations and less vulnerable to

exploitation.

J A FORD

Chairman

implementation of our recommendations, service provision to i

couples will be greatly improved as well as being cost effective

accessible regardless of place of residence. Pari passu, we firmly

success rates as well as all other aspects of infertility services sh

to rigorous clinical audit on an annual basis. In addition, becau

to be a rapidly developing field - especially in the light of recen

hope that the global provision of services, as well as research in

kept under periodic review, possibly on a triennial basis.

We respectfully commend our findings to the National Medical

Committee, the Scottish Health Service Advisory Council and t

State.

I would like to take this opportunity of personally thanking the

working group and our expert advisors all of whom contributed

this report - and my Chairmanship - could come to fruition. W

invidious to single out individuals, I owe a particular debt to D

Dr Robin Aitken and Mr Neil Leadbeater for their industrious

commitment in drafting the final report.

• 2

The group also reahsed at an early stage that existing infertility services are


Paragraphs

I Introduction 1-11

II Overview 12-29

Ill

Present Level of Service Provision 30-63

IV Meeting The Needs of Infertile Couples 64-94

It

Appendix II

Appendix III

Appendix IV

Appendix V

Appendix VI

Survey Questionnaire

Glossary of Terms

Patient Information Leaflets

Suggested Further Reading

Relevant Organisations

V Principles of Investigation and Treatment 95-128

VI Laboratory Services 129-138

VII Nursing Services 139-143

VIII Quality Assurance and Clinical Audit 144-153

IX Future Patterns of Service Provision 154-168

X

Resource Implications

169-181

Recommendations

References

Tables

Table I

Service Provision Per Head of Population

Table II

Maximum Waiting Times for Appointments

Table III

Analysis of Cross-Border Flow

• 4

u.


Infertility is a disorder which merits planned investigation and treatment within the

National Health Service. However, the current management of infertility is slow,

inadequate and expensive.

This Report argues the need for sensible criteria to be adopted at all levels of

service provision so that limited resources can be utilised to their maximum

potential. In particular, it stresses the need for greater efficiency and economy in

service provision through the use of well-defined plans and protocols.

Three levels of provision are identified: Level I which represents that offered at

present by a general practitioner or general gynaecologist; Level II which represents

'secondary' or 'specialist' care available at a district general hospital and Level III

which represents 'tertiary' or regional specialist care currently available in 4 centres

in Scotland.

The importance of quality assurance and clinical audit in meeting the needs of the

infertile is given particular emphasis. Clear guidelines are set out on the limitation

of IVF in the light of recent legislation. The report concludes that it would be

possible to estabhsh an NHS funded IVF service in all 4 Level III centres at an

initial cost of approximately £2m. The rationalised use of tubal surgery could

achieve savings of up to flm in future years.

1 Widespread concern about the provision of treatment for in

been well documented as being slow, inadequate and expensive."

professional concern has also been expressed with regard to ser

Scotland^-'^

2 In 1988, the National Medical Consultative Committee (NM

Sub-Committee in Obstetrics and Gynaecology requested that t

Working Group to consider the provision of infertility services

original remit of the Group was as follows:

2.1 To collect basic information on the numbers of individ

who can be identified in each Health Board as receiving hos

or treatment for infertility.

2.2 To identify the services currently available in each Hea

investigation and management of infertile individuals and co

2.3 To make recommendations for the provision and organ

minimum service that should be provided by Health Boards

2.4 To consider the possible options for the national provi

advanced techniques for the treatment of infertility within th

of the regulatory proposals set out in the White Paper, "Hu

and Embryology - A Framework for Legislation".

3 Certain sections of the Report were updated in 1992 in the

legislation, changes in clinical practice and amendments made b

Medical Advisory Committee.

4 The membership of the Working Group is shown in Appen

• 6

5 The Working Group met on 8 occasions during the period

of these occasions the Group met at Ninewells Hospital, Dunde

combined the business of its meeting with a tour of the IVF la


acknowledges the assistance of a number of consultant colleagues who additionally

provided information over and above that required by the questionnaires or

responded to requests seeking clarification and information on specific points.

Grateful acknowledgement is also given to the Fertility Nurses Interest Group

(FNIG), a speciahst group of the Royal College of Nursing, who submitted written

evidence at the request of the Working Group and to the members of the National

Nursing and Midwifery Advisory Committee who commented on the draft report.

7 The members were greatly assisted in their task through a series of dialogues

with the following guest speakers whose contributions have proved invaluable in

gaining an overall understanding and grasp of the subject: Professor W Thomson

(Department of Obstetrics and Gynaecology, Institute of Clinical Science, Belfast);

Mrs H O'Rawe (Chairman, National Association for the Childless, Scotland); Dr

G Beastall (Top Grade Biochemist, Department of Chemical Pathology, Glasgow

Royal Infirmary); Professor A Templeton (Regius Professor of Obstetrics and

Gynaecology, University of Aberdeen); Mrs M McGhee (Counsellor, Glasgow); Dr

R Yates (Consultant Obstetrician and Gynaecologist, Glasgow Royal Infirmary);

Professor D Baird (Centre for Reproductive Biology, Edinburgh); Dr J Mills

(Consultant Obstetrician and Gynaecologist, Ninewells Hospital, Dundee); Dr G B

James (Consultant Obstetrician and Gynaecologist, Ninewells Hospital, Dundee)

and Dr D Edgar (Embryologist, IVF Laboratory, Ninewells Hospital, Dundee).

Outline of Report

8 The first part of the report gives an overview of infertility and an account of

the present level of service provision in Scotland.

9 The specific needs of the infertile are addressed in chapter IV with particular

regard to the respective roles of the counsellor, the general practitioner and the

specialist. Principles of investigation and treatment are described in chapter V.

Chapter VI outlines the contribution of the laboratory services to the investigation

and treatment of infertility. The contribution of the nursing profession is contained

in chapter VII.

10 The application of quality control and clinical audit to the provision of a

service to the infertile is discussed in Chapter VIII.


Increase of Infertility

Definition

12 Infertility may be defined as the inability of a couple to produce the offspring

they desire during their shared reproductive years because conception fails. The

Group have deliberately excluded from this definition the problem of recurrent

pregnancy loss as this presents a different clinical problem.

17 Based on a knowledge of current and predicted population

infertility treatment is currently at its highest as a result of the

of the 1960s.

18 A further increase in demand may occur because of the tre

age of child bearing with age-specific reductions in fertility. In

also arise as a consequence of a decline in the numbers of babi

adoption.

Causes of Infertility

13 Underlying causes in the female may be attributed to endocrine or structural

factors.

14 In the male, the most common factors relate to abnormalities of sperm

numbers, structure or motility.

15 In addition, in both sexes, it is believed that other factors which may include

smoking, alcohol and stress may have an adverse affect on the ability to conceive.

Prevalence of Infertility

16 Exact figures about the prevalence of infertility are difficult to determine. The

best approximations are those which are derived from specific research studies and

the numbers of childless marriages. The latter is not in itself regarded as a precise

indicator as it is known that some 5% of the world's married population make a

conscious decision to remain childless.' It is apparent, however, that somewhere

between 1 in 10 and 1 in 6 couples experience problems with their fertility.*''" This

is confirmed by a report from Aberdeen where a retrospective study of a random

sample of women in Grampian aged between 46 and 50 revealed that 14.1% had

experienced difficulties in the past in becoming pregnant for 2 years." A retrospective

19 Furthermore, the rate of uptake is likely to be governed by

expectation as advances in new technology are gradually impro

publicised, although there is evidence that the uptake is near m

patient groups. 12

Infertility Treatment

a Drug Therapy

20 Drug therapy is used to induce ovulation. The most comm

clomiphene citrate (Clomid). Gonadotrophic drugs may be pre

who fail to respond to clomid.

b Tubal Surgery

21 Tubal surgery is used to repair blocked fallopian tubes. It

which may last for 2-3 hours and entails a hospital stay of bet

success rate is low and there is an increased risk of ectopic pre

cases, however, it carries a better or comparable success rate t

(IVF).

c Egg Donation

22 Egg donation is increasingly carried out for young women

ovarian failure which is either spontaneous or induced by chem

radiotherapy for otherwise successful cancer treatment.

• 10


23 Artificial insemination by donor is used to achieve a pregnancy in a fertile

woman when her husband or partner is infertile because of defects in his semen. It

can be used if he has had a vasectomy or if he is the carrier of an hereditary

disease which could be passed on to the child.

e in Vitro Fertilisation (IVF)

24 The first successful birth utilising the in vitro fertilisation (IVF) technique,

pioneered and developed in Cambridge by Professor R Edwards and Mr Patrick

Steptoe, took place in 1978. The technique comprises fertilisation in a glass dish as

opposed to the uterus, and involves the removal of a mature oocyte from the ovary

immediately prior to ovulation, fertilisation of the oocyte by sperm from the

woman's husband, and subsequent transfer back into the uterus.

25 The procedure was originally only adopted in cases involving absence or

damage to the fallopian tubes but it has since been widened to include other causal

factors.

26 Success rates for IVF were initially low, although with the adaptation of

fertility drugs, vaginal ultrasound and advanced freezing techniques, procedures are

being improved upon all the time.

- oocytes can be harvested by vaginal

aspiration using ultrasound (no theatre

or anaesthetist) and replaced into

endometrial cavity through cervix

— lower success rate

only fertilised eggs replaced

— opportunity for pre-implantation

genetic testing

— replac

oocytes

fallopian

laparosc

theatre a

- higher

— no gu

fertilisat

— no op

pre-impl

testing

It should be noted, however, that indications for IVF and GIFT

For example, IVF is mainly used for problems of oocyte pick u

only be used where there are normal fallopian tubes (eg in case

infertility, sperm mucus problems, and mild endometriosis).

27 Useful comparison of data is difficult to determine as the capacity of each

centre to treat patients and the type of patients treated are subject to considerable

variation. Data collected by the Interim Licensing Authority (ILA) reveal that in

1990, the average crude pregnancy rate with IVF was 17.3% per treatment cycle.

This translates into an average live birth rate of 12.5% per treatment cycle. The

average number of treatment cycles per patient was 1.16."

• 12

f Gamete Intra-Fallopian Transier (GIFT)

28 A variant on IVF, gamete intra-fallopian transfer (GIFT), was first performed

in 1984. It is similar to IVF but is distinguishable by the fact that fertilisation takes

place in vivo and not in vitro. The 1990 report of the Interim Voluntary Licensing

Authority for Human In Vitro Fertilisation and Embryology reported a pregnancy

rate per treatment cycle for GIFT during 1988 as 20.8%". This is a slightly higher

figure than that for IVF.


PRESENT LEVEL OF SERVICE PROVISION

Levels of Care

Historical Background

30 Until the end of the 1960s, the investigadon of inferdlity was relatively

unsophisticated and its treatment was comparatively ineffective. During this period,

therapeudc ovulation induction was being elucidated and facilities for artificial

insemination by donor (DI) were restricted.

31 In the 1970s, laparoscopy, DI and ovuladon induction became widely available.

Much of the treatment took place on an outpatient or short-stay basis, generally

conducted by non-specialist gynaecologists. Few designated clinics for the treatment

of infertility existed at the time.

32 At the end of that decade, the first successful birth following in-vitro

fertilisation (IVF) was achieved. Although success rates were inidally low, the effect

of this achievement was dramatic throughout the 1980s and methods for improving

the technique have continued ever since. Although treatment may appear to be

inefficient when expressed in terms of live births per treatment cycle, cumulative

success rates in experienced centres are comparable to normal conception rates.

35 As with other aspects of gynaecological speciahsation, a co

for infertility has evolved over the years. This has been matched

protocols for investigation and treatment at each level. Such a c

this report. Definitions of each level of care are given below.

LEVEL I is synonomous with 'primary', 'first line' or 'initia

represents that offered at present by a general practitioner a

gynaecologist.

LEVEL II signifies 'secondary', 'second line' or 'specialist' c

means that one or more gynaecologists in a group take both

treatment to a more advanced level, often receiving referrals

and seeing patients at a specific 'Infertility Clinic'. They ma

referrals directly from a general practitioner.

LEVEL III means 'tertiary' or regional 'specialist care' avail

Scotland by large central referral centres in the 4 Scottish ci

NB Consultants at Level II and Level III often provide care

Organisational arrangements and protocols relevant to each

in Chapter IX.

33 Other concomitant developments have taken place, either independent of the

above or as a consequence of it, for example:

- Assessment of ovulation, both spontaneous and induced, has been greatly

improved by advances in ultrasound, biology and biochemistry,

- Specialisation within Gynaecology has developed with 'Fertility' assuming a

central role in the field of reproductive medicine, and

- Consumerism has resulted in the growth of articulate pressure groups, well

informed by high quality media presentations and literature.

Basic Pattern of Care

34 The majority of patients, sometimes as a couple, initially consuh their general

practitioner. Occasionally they seek help at the suggestion of a Family Planning

Provision of Assisted Reproduction

36 Procedures for assisted reproduction are rarely available on

needs of the infertile have to be balanced against competing nee

UK, it has therefore been largely left up to the private sector to

technology procedures that are associated with IVF, GIFT and

37 Although there are now 64 IVF centres within the UK, only

are funded wholly by the NHS. The vast majority levy a charge

commensurate with the full economic cost of treatment and a n

University/Private/NHS ventures operating from NHS sites. Hu

service provision exist across the UK as a whole.

• 14

'•Ul


• 16

Aberdeen A University-based clinic at Aberdeen Maternity Hospital has been

operating on a self-funded basis since 1989. The Department receives a small

subsidy from the University Department of Obstetrics and Gynaecology. In

1991, the Centre carried out 150 treatment cycles of IVF, 30 cycles of egg

donation and 40 cycles of sperm intra-fallopian transfer (SIFT). The SIFT

cycles will be replaced by GIFT cycles this year.

The Centre charges each patient £1,450 (1992 prices) per cycle of treatment.

Dundee The Centre, which is embedded in NHS facilities, is located at

Ninewells Hospital. The Centre is subsidised by the NHS as well as by a

research grant. At present, the Centre carries out 200 IVF and 60 GIFT

treatment cycles per year. Some of the IVF cycles are egg donation cycles.

Most patients are asked to give consideration to offering a donation towards

the cost of their treatment.

Edinburgh The Centre is located within NHS facilities at the Simpson

Memorial Maternity Pavilion. Until recently, the assisted reproduction service

was financed from University research funds and NHS patients were not

charged. These funds have now ceased and treatment is only available on a

private basis. Although it has had a research programme for many years, the

main clinical treatment programme started towards the end of 1991. The

Centre plans to carry out between 200 and 300 treatment cycles per annum.

The Centre charges each patient £1,250 per treatment cycle.

Glasgow At present, there are 2 programmes in Glasgow. An NHS

programme is based at Glasgow Royal Infirmary, and a programme in the

private sector is based at The Glasgow Nuffield Hospital but there are shared

staff and protocols between the 2 Units. ,

The Centre is funded by a combination of University research funds and

income generated by a collaborative effort with the Glasgow Nuffield Hospital

whose laboratory tests are carried out at Glasgow Royal Infirmary. This

enables the Centre to offer a service to NHS patients throughout the west and

south of Scotland without charge. The Centre at Glasgow Royal Infirmary

carried out 212 IVF treatment cycles during the period April 1990 to March

1991 and 214 cycles during the period April 1991 to March 1992.

Success Rates

Legislation

involved are thought to be small.

40 Pregnancy rates per cycle within the 4 Centres in Scotland

April 1990 to March 1991 were in the range of 9-18% per treat

difficult to compare success rates unless the entry criteria and p

characteristics correspond in each of the 4 Centres. Using data

1990 to March 1991 comparative data on success rates in Scotla

Pregnancy rate

per cycle

Aberdeen 9%

Dundee 18%

Glasgow (NHS) 18%

Glasgow (Nuffield) 10%

No figures were available for Edinburgh during this period

figures looked encouraging.

NOTE: In each case pregnancy rates are given per cycle sta

patient.

41 It would appear that the longer established centres (Dundee

have better pregnancy rates. The trend is towards an improving

Glasgow and Dundee reporting very high success rates of 21%

respectively for 1991.

42 The Human Fertilisation and Embryology Act, which receiv

1 November 1990, has given clinicians and scientists a much ne

Li

I'Lu


43 A new Authority, The Human Fertilisation and Embryology Authority,

(HFEA), has been established under the Act to regulate the field of assisted

conception. The new Authority took up its full statutory responsibilities in August

1991. An account of its remit is given in Appendix VI. Prior to this, an Interim

Licensing Authority (ILA), operated a voluntary licensing system for centres

carrying out IVF and embryo research.

44 Both the Department of Health and the HFEA propose to monitor the use of

GIFT. In particular, the HFEA will consider whether GIFT, because it is not

licensed, is being used inappropriately instead of IVF. This proposal is fully

endorsed by the Working Group.

Survey of Infertility Services in Scotland

45 In 1988, the Working Group studied 2 reports produced by the National

Association For The Childless (Scotiand)* which highlighted senous shortcomings

in the provision of services for the infertile in Scotiand.'' The Group then

formulated 2 questionnaires to assess the extent and quality of the service from the

point of view of the providers, namely Scottish consultants. Copies of both

questionnaires are reproduced in Appendix II.

Questionnaire I

46 The first questionnaire required Scottish Health Board Records Officers to

identify:-

- All consultants who dealt with cases of infertihty.

- The number and location of hospital gynaecological departments and their

satellite clinics, where infertility cases were seen, and

47 Results from the first questionnaire are given below:

Questionnaire I

Total number of Scottish gynaecological consultants

Number of consultants taking referrals for infertility

Total number of "departments" (ie gynaecological

departments with central and satellite clinics)

Total number of departments with specialist activity

Total number of consultants with a special interest

in infertility

48 A second questionnaire was sent to the 21 consultants with

infertility and to the remaining 57 gynaecologists who did not h

arrangements.

49 Seventy-eight questionnaires were sent and 61 replies were

response rate). All 21 consultants with a special interest in infer

50 The aim of the second questionnaire was to assess 3 aspect

provision currently available in Scotland, namely:

Analysis of Results

— patient access to services

— patterns of investigation and treatment

— shortcomings in the service as perceived by care provid

Results from the second questionnaire are given below:

Geography

51 Fifty per cent of the Scottish population reside in areas serv


20 miles should Level III care be required.

Genital Tract

• 20

Access

52 The remaining half of the Scottish population is served by the equivalent of

District General Hospitals both large and small contained in the 9 other mainland

Health Boards. Aberdeen Royal Hospitals NHS Trust provides facilities for Orkney

and Shetland; Caithness has a single-handed consultant facility related to Highland

Health Board. Because many of the areas in this second group have large rural

hinterlands, nearly all have satellite peripheral clinics where investigation is

initiated with treatment being completed at the related base hospital.

53 Maximum waiting times are shown in Table II. Due to organisational

problems and backlogs, maximum waiting times in 4 departments ranged from 17

to 72 weeks for certain forms of treatment at Levels II and III, but in the

remaining 30 departments, it did not exceed 14 weeks. In 5 of these centres the

waiting time was 3 weeks or less. Out of 61 respondents, 51 gave no particular

priority to fertility cases. A 7 day per week facility was available at 16 of the 34

departments and these were represented mainly by those where care at Level II and

Level III was given. Much of this concurred with the findings of the 2 reports

issued by the former National Association For The Childless (Scotland).

Patterns of Investigation

Ovulation

54 Respondents were asked to identify whether they performed certain tests under

the headings "Always" "Often" "Occasionally" or "Never". The following results

emerged:

55 As many as a third of respondents still use temperature charting and

endometrial biopsy to assess ovulation despite these being no longer regarded as

appropriate. More sophisticated tests such as luteinising hormone assay, cycle

hormone and ultrasound profiles are utilised by only half of the respondents most

of whom are consultants with a special interest in infertility. However, follicle

scanning is becoming increasingly available and is mainly performed by

56 Tests involving cervical mucus are performed regularly by

the respondents with more sophisticated testing such as sperm

sperm mucus interaction tests being performed by very few res

Laparoscopy is used by all, to a varying extent whereas X-ray h

is "Always" or "Often" used by only 16 of 61 respondents.

Male Infertility Factors

57 All respondents perform semen analysis but only two-third

for its collection and inspection. Hormone assays are only regu

consultants with a special interest in infertility.

Patterns of Treatment

58 Respondents were questioned about their management of 3

encountered clinical situations, which until recently had not be

treatment; namely the presence of mild endometriosis, cervical

couples in whom no cause is found on conventional testing. Th

about 50% of cases, can now theoretically be helped by metho

Reproduction'. The survey showed that after various forms of

cases were referred to Level III centres or the private sector.

Tubal Surgery

59 Tubal surgery is still mainly performed by general gynaeco

61). Microsurgery, which increases the chances of conception f

rarely used. The Working Group consider that this situation m

reproduction facilities develop.

Artificial Insemination by Donor

60 In addition to the 4 Level III Centres, facilities for artificia

donor are available at Monklands District General Hospital, A


Assisted Reproduction

61 Assisted reproduction is mainly performed at the 4 Level III centres. At the

time of the survey the Group discovered that many patients from Grampian and

Lothian were being referred to private sector facilities in England.

Gross-boundary Flows

62 Table III illustrates existing patterns of cross-boundary flow required for

various aspects of investigation and treatment. It would appear for Level I

investigations that no difficulty is being encountered generally in obtaining

hormone assay. However, there is much cross-boundary flow for DI and some for

specific ovulation testing and induction at Level II.

Shortcomings

63 Shortcomings for the service locally and generally as detailed by the

respondents reveal that a lack of consultants with a special interest in infertility

outwith the main centres remains a problem although many respondents

particularly in the District General Hospitals would wish to have such an

arrangement. Access to DI is also very variable and unsatisfactory. Comments from

the main centres reaffirm well-recognised deficiencies, namely funding and the

organisation of the service.

Introduction

64 Figures mentioned earlier in the report indicated that appro

couples experience infertility yet only one in ten couples appro

discuss the subject. Inability to conceive can lead to frustration

proceed to anger and grief. These painful experiences, which o

from others who have been successful in producing a family, re

management at all stages of counselling, investigation and treat

The Role of the General Practitioner

65 The general practitioner is usually the first point of contact

reveal that there are a sizeable number of couples who do not

seek assistance at all. While opinions differ, it seems not unreas

contact their general practitioner if there has been a failure to c

of regular sexual intercourse during the most fertile time in the

cycle. It is important to ascertain beforehand, however, that the

practitioner is likely to adopt a supportive stance and have an

knowledge of outcomes. The management of emotions does no

priority that it deserves when attention is focussed solely on the

Couples can be extremely vulnerable and an indifferent attitude

The Working Group recommend that the management of infer

be handled with due sensitivity at all levels of care so that full

of emotional needs and attempts are made to reduce levels of s

understanding, tempered with a good deal of realism, is the bes

order to assist the couple to gain an emotional insight into thei

66 A survey carried out by the former National Association fo

(Scotland)' suggested, despite its low rate of response, that a su

general practitioners did not show much interest in the investig

of infertile couples. This could well be an area where those res

• 22

11


• 24

have a special interest may declare this in both the local directory and their patient

information leaflet.

68 Arrangements for clinical audit, advocated in the same document, place a

requirement upon Health Boards to assess patient satisfaction. Compliance with

this should include periodic surveys of patient satisfaction in the field of infertility

services. All these factors may assist couples to select general practitioners who are

known to be supportive to their particular specialist needs.

69 The first task of the general practitioner should be to ascertain the family

plans of the couple, and this should be done by seeing both partners together. The

Group have been made aware of examples where couples have proceeded with

infertility treatment whilst using contraception, and of instances where it has only

become clear at a later date that one partner has no real positive desire for

children at all. Others may be seeking support for a state of childlessness to be

conferred upon them in order to counteract family or peer pressure for offspring.

70 The general practitioner should explore all options available to the couple

acting in the guise of both informant and counsellor, as well as adopting the more

traditional investigative role. Some couples, when confronted with the reality of

invasive, diagnostic and treatment procedures may prefer to remain childless, even

at this early stage. Whatever the outcome of these discussions, it is essential that

the couple be given adequate time to consider all the options away from the

surgery in the privacy and quiet of their own home or to seek further information

from a professional or lay counsellor. No pressure should be placed upon them to

reach a decision at the conclusion of the consultation. Couples, whether or not

they seek treatment, must be assisted to come to terms with their fertility problem.

71 The Working Group recommend that the general practitioner or a member of

his team be designated as a key worker to assist couples throughout the entire

treatment process in order to achieve continuity of care.

Use of Protocols

72 Locally-devised protocols for general practitioners covering preliminary

investigations and their role in the service are not generally available but there is

73 These protocols should cover the current definition of infe

of the general practitioner, basic investigations which would b

referral, and such optional investigations as may be appropriat

locally. Investigations which should be included in such a prot

greater detail in Chapter VI.

Referral Times

74 Many couples experiencing infertility find that waiting is a

problem. Modern society conditions us to expect instantaneous

problem of having to wait at every turn of the treatment proce

what is often an already stressful situation.

75 The Working Group has been very conscious of the fact t

results of its survey, priority appointments are for the most pa

patients requiring hospital treatment for infertility. The forme

Association for the Childless (Scotland) indicated that initial re

first point of contact with specialist services varied between 2

76 The Working Group were made forcibly aware of the fact

great variation in the time taken for investigations. The forme

Association for the Childless (Scotland) indicated variations w

months to 6 years. Whilst it is acknowledged that services for

complex, such variation reflects poor management and disorga

in some cases be prompted by a lack of resources. In addition

was conscious that some inappropriate first-line referrals were

III centres and that at times, the sequence of referrals was unc

77 A survey carried out by the former National Association f

(Scotland) in January 1988 revealed a considerable discrepancy

times acknowledged by Health Boards and those reported by t

Uncertainty about waiting times does not allow patients to ma

between NHS and private provision. Locally set targets for wa

advocated by the Patient's Charter" should go some way to re

situation. Publications, providing basic information on IVF clin

Ml.


• 26

been made, the department should be obliged to advise the general practitioner of

the likely waiting time. At that point, the couple should be made aware of the

waiting times of other departments providing the same service, if these are

substantially shorter.

79 In summary, general practitioners are sometimes unclear of the availability of

Level II and Level III services. This is particularly true where cross-boundary flow

occurs. The Group recommends that clear, published guidelines be made available

about referral and waiting times for Boards to ensure that there is adequate

cross-purchasing of Level II and Level III services without discrimination to couples

living in areas where no such service is provided.

Patient Information and Literature

80 Written information is important in many aspects of good medical

management particularly in the case of infertility services, where couples are

known to be intensely anxious in the initial stages. Written information should

not, however, be used as a substitute for counselling.

81 The Working Group examined a number of locally available information

sheets. These varied in terms of quality of production and terminology. A number

of information sheets were, however, commended by the Working Group as

suitable models for adaptation across Scotland. Examples of some of these sheets

are contained in Appendix IV.

82 The Working Group recommend that patient literature on the investigation

and treatment of infertility, including its prevention, should be made widely

available through GP surgeries, retail chemists, local support groups and public

libraries.

83 The Working Group further recommends that each practice, as opposed to

each individual general practitioner, should be aware of:-

- those services available locally and, where these are incomplete, the

appropriate regional or national services;

Counselling

84 These recommendations are in accord with current Govern

the NHS.

85 A clear distinction should be made between counselling an

information and clinical advice. Counselling offers an opportun

discover ways of coming to terms with their situation whereas

information is more of an instructive device.

86 The Working Group gained the overall impression from p

that the emotional and psychological needs of the infertile coup

an adequate way by present services. Daniluck et aP' report in

of 43 couples, that infertility investigations resulted in anxiety

most intense at the time of the initial medical interview, but ha

particularly at the time of the receipt of test results. Although

no time incapacitating, they nevertheless hindered the ability o

information on a verbal basis. Whilst only 53% of males and 7

this study indicated that they would personally use counselling

available, 95% of males and 98% of females considered that su

facilities should be an integral part of an infertility service.

87 Counselling, which was recognised as being an important

infertility service by the Warnock Committee'^ is now a requir

Fertilisation and Embryology Act and the HFEA Code of Pract

on how it expects centres to fulfil their statutory obligation in

Scotland, Level III Centres in Aberdeen, Dundee and Glasgow

collaborating in a large project to assess the value of counsellin

the Human Fertilisation and Embryology Act.

88 The Working Group strongly recommend that all clinics, e

should have access to individuals with appropriate counselling

many of the problems can be helped during initial referral by s

perceptive handling.


psychological aspects. They should also be aware of, and work closely with, local

support groups, and should liaise with the local social work department to advise

couples who have opted for adoption. Couples should be made aware of the

implications and likely outcomes of each particular process and be able to reach an

informed rational decision in relation to each successive stage of treatment.

90 Couples should be encouraged to seek help from a counsellor before referral to

any type of infertility service. The counsellor should act as a key worker for the

couple, unless there is a member of the primary team with a special interest and an

up-to-date knowledge in this field. Ideally, the same counsellor should continue to

act as a key worker throughout the whole process to give continuity to the

treatment plan and should have sufficient knowledge of infertility and of the

services available to assist each couple to make a balanced decision but it is

recognised that for practical purposes this may not always be possible.

91 The counsellor will also need to help couples through the psychological

reactions commonly encountered by the infertile.

92 The counsellor also has an important role to play in helping couples who have

not responded to treatment by assisting them to adjust to the experience of being

childless.

Adoption and Fostering

93 Adoption and fostering are not treatments for infertility and the couple must

be given time to adapt to the fact that they are unable to have children of their

own before they move on to the possibility of becoming adoptive or foster parents.

Surrogacy

• 28

94 Surrogacy should only be contemplated as a last resort in accordance with the

guidelines laid down by the British Medical Association."* Surrogacy arrangements

are not illegal though the law makes clear that any such arrangement is not

enforceable in the courts. The welfare of the child in respect of the carrying


Infertility Investigation

95 Although infertility carries no direct hazard to health, some of the

investigations associated with its management require surgical procedures,

sometimes involving anaesthesia, and may carry a risk to well-being.

96 It is often difficult to decide what constitutes infertihty, and when investigation

should begin. Determining the appropriate investigation, and who should be

responsible for carrying it out has implications for the efficient use of the service

and the best interests of the couple concerned. It is worth bearing in mind that a

number of patients will conceive irrespective of treatment.

97 It has to be acknowledged that there are cases where no explanation for

infertility can be given at present. This group of patients will continue to form the

subject of further research. In the meantime it is our view that rational

investigation should be undertaken in a properly organised way in order to achieve

the best outcome for patients in the most efficient and cost-effective manner.

The Practical Approach to Infertility Investigation

98 A practical approach to investigation is to try to identify causes that have a

solution. A logical way to approach this would be to start with simple

investigations which lead to simple remedies, and then to progress to more

complicated investigations where appropriate.

99 Given that infertility increases with age, investigation can become quite urgent

if the woman is in her thirties. By the time the older woman has completed her

investigations, 'high technology' treatments may no longer be appropriate. It is

therefore essential that the age of the individual should be taken into account

before a plan of investigation is embarked upon.

Group consider that it is essential that there is a defined plan o

a specific end point. This approach should minimise the presen

patients to be submitted to repeated investigations with a subse

scarce resources. Careful attention should be paid to the record

communication between clinicians so as to avoid unneccesary d

collection and testing.

101 General practitioners are ideally placed to obtain the detai

medical background, and will therefore be in a position to iden

underlying problems of coital failure, failure of spermatogenesis

Hormone and semen analysis could be initiated, when appropri

agreed with the local referral centre.

102 It is unrealistic, however, to expect all family doctors to su

of expertise in the management of infertihty because they may o

very few new infertile couples per year. Many will continue to

at an early stage but where general practitioners wish to initiate

themselves, the Working Group recommend adherence to a clea

investigation agreed between the general practitioner and the lo

Progression of Infertility Investigation

103 The Working Group believes that the investigation of infe

very easily to the adoption of a logical sequence of steps as indi

following algorithm which, subject to professional views, could

circumstances and form the basis of a locally agreed plan. It is

the use of protocols should be mandatory and applicable to all

element of flexibility should be present, however to permit their

application. These protocols should be subject to review and up

basis.

• 30


electroejaculation and insemination and cryopreservation of sem

Surgical procedures

105 Surgical procedures, including microsurgical procedures, m

overcome obstruction, perform a testicular biopsy or operate fo

maldescent. Several studies evaluate the effectiveness of testicula

correction which may be an important factor in around 10% of

treatment."'^' Whilst many of the results are conflicting, a wellrevealed

a significant long-term improvement in the cumulative

106 From the evidence available to the Working Group, no pro

experienced with regard to waiting lists for reversal of vasectom

Ql

01

E

05

T3

ca

CO

c/3

CD

05

o

Donor insemination

107 Donor insemination (DI) is a widely accepted means of ov

in the male. Demand for donor insemination is increasing all th

estimated to be around 500 new couples per annum in Scotland

hospitals all recruit donors and have facilities for banking seme

of the smaller district general hospitals with Level II facilities p

using purchased cryopreserved semen from the University of Br

must be examined to make sure that they are in good physical

They must be screened for hepatitis, HIV infection, sexually tra

and chromosomal disorders. Their blood groups must be determ

semen tested to check that they are fertile and that it can be sto

quarantine period of 180 days is now required for donor sperm

Electroejaculatlon and Insemination

108 Techniques for electroejaculation and insemination for inf

the husband is paraplegic are available, and are known to be su

o

<

Cryopreservation of Semen

109 Cryopreservation of semen is widely available for men wh

testicular surgery, irradiation or chemotherapy, and should be c

case as a matter of good practice.

• 32


• 34

- Before undertaking donor insemination, donors should be counselled, and

assessed for their suitability. There should be extensive counselling of couples

supplemented by written information, with full recognition of their need for

time to reflect, balanced by the need to avoid the development of lengthy

waiting times, in view of the declining fertility of women after the age of 30.

The setting and provision of such counselling is set out in the HFEA Code of

Practice.

- Success rates of around 13% per cycle, with a cumulative pregnancy rate of

75%, can be maximised by accurate ovulation prediction and the timing of

insemination. The timing of ovulation is best achieved using plasma luteinizing

hormone. Equally effective and more economical is the use of home-based

urinary luteinizing hormone assays. A limit is recommended for the numbers

of cycles of treatment offered in view of the high marginal cost of additional

treatments after 5 or 6 cycles. The female partner should be fully investigated,

including laparascopy, if pregnancy does not occur early.

- Insemination should be carried out by a gynaecologist, a suitably trained

general practitioner or infertility nurse, or by the couple with prior instruction.

- Clinical records should reflect the need to maintain anonymity and

confidentiality, whilst preserving accuracy and the facility for follow up.

111 The Working Group endorse the long-standing proposal to have a national

sperm bank in Scotiand. It would not be practical for more than one sperm bank

to be established because of the difficulties in recruiting donors and maintaining

the quality control of the samples including quarantine provision for HIV.

112 The place of assisted reproduction techniques in the presence of poor quality

semen has not yet been fully evaluated although much research has been focussed

in this area.

Treatment of the Female

113 Routine methods currentiy available for the treatment of infertility in the

female comprise reversal of tubal ligation, surgery for tubal damage and ovulation

induction.

that conducts both IVF and tubal surgery.

115 A code of good practice for the routine treatment of fema

ensure that reversal of sterilisation and surgery for tubal damag

extensive counselling on the poor success rates and the subsequ

pregnancy. Surgery should be performed by experienced gynaec

access to microsurgical equipment.

Ovulation Induction

116 Failure to ovulate is normally indicated by the absence of

(amenorrhoea) or infrequent periods (oligomenorrhoea).

117 There is good evidence that medical treatments such as cl

gonadotrophin for hypothalamic dysfunction, and bromocriptin

hyperprolactinaemia restore fertility to near normal levels."""

118 Treatment of ovulation failure with clomiphene should alw

the hospital clinic, although the general practitioner may assist

monitoring and management. Monitoring by fast hormone assa

ultrasound should allow for correct adjustment of dosage. Facil

the luteal phase progesterone are widely available. Multiple pre

looked for when ovulation has been induced with clomiphene.

119 For the treatment of hyperprolactinaemia, bromocryptine

and is sometimes prescribed by the general practitioner. This fo

however, is best left to specialist clinics rather than general pra

hyperprolactinaemia is present, then the prescription and treatm

monitored from a specialist infertility endocrine clinic. Visual fi

pregnancy is required for women with prolactinomas.

Specialised Treatments

Ovulation Induction by Gonadotrophins

120 Ovulation induction by gonadotrophins is widely available

treated in Level III clinics. Gonadotrophins should not be used,


IVF and GIFT

121 Both medical and surgical treatments for mild endometriosis have been shown

to be ineffective.""^' However, for couples who have failed to conceive naturally,

IVF and GIFT appear successful. Retrospective data indicate a pregnancy rate up

to 15-19% per cycle for IVF and GIFT in endometriosis.""'' Maternity rates per

cycle for IVF of 14%", 15%'" and 18%'' have been reported. IVF and GIFT also

appear to be the most effective forms of treatment for unexplained infertility. A

12% maternity rate per treatment cycle has been reported for couples with

unexplained infertility who were treated with IVF in the UK."

Patient Selection Criteria

122 In considering the extent to which the NHS should meet the needs of infertile

couples, the Working Group consider that treatment should be made available

through the NHS for women with damaged tubes, and for selected cases of

endometriosis and oligospermia and for women with unexplained infertihty of

more than 4 years duration.

123 With regard to the selection of patients for IVF, the Working Group

recommend that a maximum of 3 treatment cycles should be offered to each

patient and that this treatment should be restricted to women up to and including

40 years of age. Unless there are extenuating circumstances, unexplained infertility

should be of at least 4 years duration at the time of treatment starting.

Furthermore, it is recommended that unless exceptional circumstances dictate to

the contrary, women who have had failed reversal of sterilisation and/or women

with responsibility for at least 2 children within their present relationship should

not be eligible for infertility treatment within the NHS.

Authority", the overall multiple pregnancy rate across the UK

recorded as 25.6% compared with 26.8% in 1989. Whilst the a

triplet pregnancies has increased slightly from 65 in 1989 to 69

percentage of all IVF pregnancies, the rate has reduced^". The n

quadruplet pregnancies reduced from 3 in 1989 to one in 1990.

127 Concerns previously expressed by the Interim Licensing A

increased demand that these multiple births place upon overstre

services have to some extent been assuaged because it is not no

replace large numbers of embryos to achieve a satisfactory chan

128 The HFEA has stipulated that no more than 3 embryos sh

in any one treatment cycle. However, many centres are only re

favourable couples since there is broad agreement that this does

reduce the pregnancy rate. With the wider availability of embry

transfer of more than 2 embryos should now be the exception

rule.^' Because of the high financial costs of neonatal intensive

personal and financial costs to families of multiple births, purch

should specify in contracts that not more than 2 embryos shoul

124 The Working Group recommend that patient selection criteria be kept under

regular review.

• 36

Multiple Births

125 Complications are common in multiple pregnancies, especially the higher

multiples, which have a very poor prognosis. In view of this, couples should


Introduction

the next treatment cycle. Timing is viewed as being all-importa

hormone assays can be extremely complex and can only be ach

if adequate information is given. Full consultation between lab

clinicians is viewed as being essential in this context.

129 It is essential that laboratory staff are involved at an early stage in

investigations for infertility. Such involvement should include agreeing detailed

protocols in conjunction with the clinician for the investigation of infertility,

providing advice on the use of protocols, monitoring the progress of individual

patients and attending regular meetings with clinicians to discuss results.

130 Tests for the investigation of infertility are expensive. It is therefore seen as

important that a detailed history and physical examination is undertaken prior to

any initial request being made for a laboratory test.

131 Laboratory investigations for infertility can be broadly classified into 3 areas

of activity, namely, preliminary tests, sophisticated tests and highly specialised

tests.

Tests at Level III

134 It is recommended that highly-specialised tests such as pit

testing and follicular scanning should be restricted to Level III

employ specialists in reproductive medicine or clinicians with a

expertise in infertility.

135 To reduce resource use in laboratory and clinical facilities

prior to IVF or GIFT to use luteinizing hormone-releasing horm

"down-regulate" ovarian function prior to ovulation induction

so that both oocyte retrieval and embryo or oocyte replacement

during normal working hours. Super ovulation is practised so t

embryos can be chosen for replacement; others may be frozen f

• 38

Tests at Level I

132 The only preliminary hormone test that is of value in a regularly

menstruating female is plasma progesterone. On the other hand, if the female is

oligomenorrhoeic (usually defined as a cycle greater than 42 days) then the

measurement of oestradiol, gonadotrophins and prolactin is indicated. These

preliminary tests should be generally available to all practitioners undertaking

infertility work.

Tests at Level I

133 Sophisticated tests may include menstrual cycle tracking to establish whether

normal ovulation is occuring. Since this is a specialised requirement, it should be

restricted to those gynaecologists involved in more detailed infertility work.

Sophisticated tests such as gonadotrophins, androgens and 17-hydroxy-progesterone

Organisation and Management

136 The Working Group recommend that rationalisation of la

should be explored. Clinicians are now able to control the timi

hormone manipulation therapy maximising the use of laborator

facihties during the 5 days of the normal working week. This r

avoids anti-social hours for laboratories, theatres and medical a

services were rationalised, laboratory staff would gain wide exp

measurement of the various assays leading to good quality cont

results. Experience gained could be passed on to the clinician in

137 Infertility services generate considerable work for laborato

increase in the number of assay methods and also the time requ

results and transmit information to the appropriate clinician.


consider that this may result in a misuse of resources since many unnecessary and

inappropriate investigations may be requested. For this and other reasons, the

Working Group consider that it is appropriate for protocols to be designed at a

number of levels for the management of infertility patients. Such a system needs to

maintain a certain degree of flexibility to permit practical apphcation.

Introduction

139 The Working Group recognise the important role played

the overall management of infertility. It is for this reason that,

consultation exercise, evidence was sought from the Royal Coll

Fertility Nurses Interest Group (FING), and members of the N

Midwifery Advisory Committee.

Extent of Activity

140 Nurses are involved in a very wide range of activities whi

from clinic to clinic. Procedures with which they offer assistanc

summarised as follows:

— artificial insemination, both intra-uterine and intra-cerv

or donor samples;

— sperm mucus interaction tests;

— semen analysis;

— ultrasound follicle scanning;

— assisting at oocyte retrieval procedures and embryo tran

Practice nurses are increasingly involved in the administration o

sometimes on a daily basis. Nurses are also involved with histo

giving of advice and information. Nurses have a major role to

counselling and support to infertile couples.

• 40

141 Despite the above, it should also be mentioned that in som

of nursing involvement may be restricted to pre and post opera

GIFT procedures. It appears that many nurses working in gyna

departments assist with infertility clinics as and when required.


Training

Conclusion

142 Given the estimated incidence of infertility, the Working Group recommend

that a Professional Studies II Module on Infertility should be developed in Scotland

by Health Board Colleges of Nursing and Midwifery and Departments of Nursing

in Higher Educational Establishments and made available to nurses working in this

field.

143 The Working Group wish to acknowledge the role of the nurse in infertility

treatment and endorse the work of the Fertility Nurses Interest Group in

promoting and supporting the education and training of nurses for their role in this

area.

Introduction

144 Quality assurance covers all activities and functions conce

attainment of quality. Its objective is to make sure that quality

be in order to satisfy given needs. This implies a commitment o

providers to an on-going evaluation of the adequacy and effect

and procedures with corrective measures being instigated where

to be able to assure quality it is necessary to be able to measur

145 Clinical audit is one aspect of quality assurance, consistin

critical analysis of the quality of patient care, including the pro

diagnosis and treatment, the use of resources, and the resulting

quality of life for the patient.

Quality Assurance

146 The issue of quality, which is of the utmost importance in

medical nature, is particularly important in the field of infertili

vulnerable when confronted with the task of having to discuss

their lives in a clinical setting. Emotional factors come into play

to be handled in a sensitive manner so that an atmosphere of c

can be established at the outset in the doctor-patient relationsh

time-consuming and attendances at hospital clinics can often be

regular basis over a period of several years. There is therefore a

be used effectively and for details to be accurately recorded on

Sophisticated treatments are expensive and their outcome is at

particularly successful. Care needs to be taken to ensure that, f

view of both the clinician and the patient, these treatments are

where they are considered to be absolutely necessary and there

willingness on the part of the patient to undergo such treatmen

knowledge of all that it entails.

• 42


unnecessarily distressing for these couples to be in the same room as patients who

are pregnant, require sterilisation or are seeking an abortion in the same treatment

area.

148 In cases where the male partner is asked to produce a semen sample,

adequate provision should be made for this eventuahty. A comfortable bedroom

with a lockable door should be provided for this purpose. The use of a toilet in

this instance is regarded as being totally unacceptable. Wherever possible, the male

partner should be afforded the opportunity to produce the sample at home.

149 Every patient should be given a treatment plan with a specific end point in

accordance with a locally agreed protocol. The establishment of these protocols

should assist in preserving a measure of continuity much needed in the field of

infertility. Teamwork is crucial in an area where there is a high rate of referral

from one level to another and the possibility of a range of specialists being

involved. This situation is particularly acute when the source of the problem

appears to lie with the male partner. Male factors in infertility are best dealt with

by an andrologist or urologist since gynaecologists may not possess expertise in

this area. A team approach to infertility at Level III might well comprise a number

of specialists including a gynaecologist, a urologist, an embryologist and an

ultrasonographer, as well as junior doctors, nurses and laboratory staff.

developed which would include patient satisfaction with treatm

152 Greater attempts should be made to produce data that ca

comparison across all Level III centres - a matter which is diff

present as different centres take on different types of patient a

different methods of treatment. This audit should also be appl

centres. To some extent the HFEA provides a framework in w

issues can be addressed. In addition, there is evidence of effect

between centres in Scotiand but this is not yet so apparent els

153 There should be a continuing commitment to specialised

research and a regular forum should be established for an exch

disemmination of good practice. The role of the Royal College

and Gynaecologists and its recognition of sub-specialty training

important in this respect.

150 The timing of investigations is crucial, as tests have to be undertaken at a

particular point in a woman's menstrual cycle for the results to be meaningful.

Clinics should as far as possible offer a service to ensure that women are tested at

the appropriate time. Difficulties in matching appointments with cycles can result

in treatment being unnecessarily protracted, and allow an element of frustration to

be built up within both partners.

• 44

Clinical Audit

151 Clinical audit should examine both the qualitative and the quantitative

aspects of medical care by external peer review. Accurate statistics will need to be

kept under specific headings such as patient throughput, waiting times for

investigation and treatment, success rates per cycle of treatment and cumulatively


• 46

Forecast of Demand

154 Assessing the demand for services, present and future, is difficult. The

Working Group had hoped to carry out a census of new couples attending all

Scottish departments and their satellite clinics during a fixed period, but the

potential for ensuring that such an exercise would be accurate and complete was

doubted. It was felt that assessing the optimum timing and the correct length of

study, as well as differentiating primary from secondary referrals would prove too

difficult in the time allowed. An incidence of approximately one new couple per

thousand population served was reported from Bristol. Similar rates have been

reported from Lothian, Grampian and Tayside.

155 Any change in present numbers could depend on a variety of factors, some

complementary and some conflicting. Points which may be relevant to this

argument are highlighted below:

- an increase in the numbers of individuals in the reproductive age group

until the end of the century

- changes in the current trend towards delayed planned childbirth

- changes in the background incidence of pelvic infection^'

- more approachable and better organised services which may prompt more

couples to come forward for investigation.

- better counselling which may actually deter some couples from taking their

problem further.

156 Planning becomes possible in the light of assumptions being made about the

incidence of one new couple per thousand population served presenting for

treatment for infertility. By applying generally accepted figures for the incidence of

the various causes of infertility, health boards could assess the potential demand

for services in their area at all three levels of care.

replacements. In the long term, by appropriate new consultant a

the mutually agreed adjustment of existing consultant sessions, a

evolve where each department possesses the appropriate number

with a special interest in infertility - in some cases accredited by

of Obstetricians and Gynaecologists as "Sub-specialists", conduc

clinics where all the precepts of good infertility care detailed els

report are practised.

158 Each of the 4 centres has a major responsibility for trainin

infertility, included assisted conception. Two of the centres (Abe

Edinburgh) are accredited by the Royal College of Obstetricians

Gynaecologists as recognised centres for training in Reproductiv

centre in Glasgow has been recognised in the past but the traini

currently in abeyance. It is likely that the centre in Dundee wou

if it were to apply.

Patterns of Provision

Level i

159 The sequential pattern of National Health Service care rem

unchanged. The majority of patients initially consult their gener

self-referral. Counselling should be undertaken at an early stage

discretion of the couple to elicit any lack of knowledge or anxie

the attitude of the couple to the likely path of care thereafter. A

plan of investigation relating to Level 1 management devised by

the chosen department known to the practice should be invoked

being referred when the protocol is complete.

Level il

160 Couples referred to Level II facilities should be interviewed

separately and counselled by an infertility nurse at an early stag

should be arranged if it has not already been performed. Protoc

detection and a full assessment of the genital tract should be co

classified and the appropriate therapy initiated. If treatment can


• 48

vary.

162 Level II protocols and treatment plans should be developed. The referring GP

should be kept fully aware of these matters. Consultants with a special interest in

infertility at Level II should inform themselves at all times of new developments

and techniques by attending Level III centres. In some instances, it may be

beneficial for consultants with a special interest in infertility at Level III to visit

Level II departments to see cases for themselves for the purposes of providing an

element of continuing education and affording an opportunity for clinical audit.

Level lli

163 For reasons of geography, it is likely that Health Boards in the south west of

Scotland and those to the east and north of Scotland will continue to relate mainly

to their respective Level III centres as at present. Treatment undertaken at Level III

pre-supposes greater expertise and greater costs.

164 The Working Group recommend that both IVF and GIFT should be restricted

to existing Level III centres where there is appropriate laboratory support and

where facilities are being developed for embryo cryostorage. This should not

preclude other hospitals being involved in the work-up prior to assisted conception,

provided there is a clearly agreed protocol between the feeder hospital and the

referral centre.

165 Proliferation of small units should be avoided as success rates seem to be

higher in larger units. This is borne out in the UK data produced by the Interim

Licensing Authority as indicated in Figure 1.14

Figure 1

(a)

Treatment

IVF DATA 1990

Treatment Egg Embryo

Patients Cycles Collections Transfers

Large Centres (8)* 5,218 6,165 5,131 4,276

Medium Centres (21) 3,814 4,365 3,751 3,162

Small Centres (35) 932 1,053 947 757

TOTALS (64) 9,964 11,583 9,829 8,195

Large Centres (8) 1,198 876 223 4

Medium Centres (21) 672 484 134 1

Small Centres (35) 134 83 44

TOTALS (64) 2,004+-!- 1,443 401 6

* The figures in parentheses are the numbers of centres incl

returns.

+ This refers to a pregnancy resulting in at least one live ba

++ 57 pregnancies lost to follow up.

+++ Perinatal Mortality Rate is 19 (PMR (E&W) in 1990 was

The centres have been grouped into those performing more than

cycles per year (large), those performing 100-400 treatment cycle

those performing fewer than 100 cycles (small). Over 50% of the

cycles carried out during 1990 were performed in the 8 large cen

less than 10% in the 35 small centres.

Source: Interim Licensing Authority

166 The Working Group is concerned that access to assisted co

techniques in Scotland is determined largely by a couple's ability

recommends that every involuntarily infertile couple should be e

choose, to receive a proper and well-ordered investigation leadin

to diagnosis and treatment under the general provision of the NH

Group also recommends that resources for IVF and GIFT should

funded. Permanent reliance on funding from charitable sources -

part - is totally unsatisfactory and acts as a deterrent to long-ter

and development.

167 It is suggested that the 4 Centres should be funded, at least

basis of the following number of treatment cycles per annum:


X RESOURCE IMPLICATIONS

Future Reviews

168 The Working Group recommend that the development of infertility services in

Scotland be kept under review and that protocols be regularly updated. This is a

rapidly changing field of medicine and the need to keep up to date with progress is

paramount. It is suggested that these reviews be undertaken by a small group of

experts convened by, and reporting to, the Clinical Resource and Audit Group

(CRAG) with authority to make recommendations which could be included in local

protocols. These experts should collectively act as an audit group for infertility

services in Scotland and as a stimulus to education and research.

Introduction

169 In vitro fertilisation is an expensive procedure. Whilst it is

infertile women, there are attendant health risks.^^"^' Few attempt

to appraise it in economic terms. Its true cost is often underestim

studies simply calculate the cost per liveborn baby associated wi

cycle only. Moreover, the cost of infertility treatment cannot alw

distinguished from the cost of other gynaecological services.

170 Nevertheless, evaluation of direct and indirect costs of assis

must be seen as an integral part of rational planning. To calcula

one birth from IVF it is necessary to include the cost of drugs, m

human resources for all treatment cycles, irrespective of outcome

should embrace the cost of all subsequent procedures such as hig

care, caesarean section and neonatal services. To complete the e

necessary to assess the impact that an NHS-funded IVF service i

other forms of infertility treatment, in particular, tubal surgery.

approach is not without error since it is based on the assumption

never achieved without IVF whereas it is known that pregnancy

of treatment are often high.

171 Finally, it is necessary to compare the cost of IVF to the co

unrelated procedures which are carried out in the NHS, in order

proper context. This exercise is not merely of academic interest.

expended on IVF, then it follows that some other service must b

• 50

'Hospital Planing Note 1-In-patient Accommodation. Supplement K. Acutely Disturbed Mentally-Handicapped Patients.

The Cost of an NHS-funded IVF service to Scotland

172 The Working Group has not attempted to cost the establish

service from scratch since the rudiments of the service in terms o

physical resources and equipment are already in place. No attem


• 52

173 Based on a cost per treatment cycle of £1,400 (inclusive of drugs and

consumables) and a combined forecast demand from all 4 Level III centres of

between 1,250 and 1,450 treatment cycles per annum (paragraph 167) it is

estimated that the total cost of introducing an NHS-funded service would amount

to between £1,750,000 and £2,030,000 per annum. These costs are a conservative

estimate because they do not take into account laboratory costs or training costs.

174 The Working Group expect some of the cost of introducing a fully-funded

IVF service to be offset by savings resulting from a more rationalised approach to

tubal surgery and other savings as a result of greater efficiency in the management

of infertile couples.

The Impact of IVF on Tubal Surgery

175 The Working Group consider that the introduction of IVF could achieve

savings in secondary and tertiary care by reducing the need for tubal surgery.

Given that it is still appropriate to treat a certain number of patients by tubal

surgery insofar as it carries a better or comparable success rate to IVF, it has been

estimated that in one centre during the year 1990-1991, 45 out of 117 patients with

tubal or related disease who could have been treated by tubal surgery would have

been treated by IVF because of the higher success rate. Thus, the introduction of

an IVF programme would have saved the cost of carrying out 45 tubal surgery

cases. On the assumption that each case of tubal surgery costs £2,000^', this would

have resulted in a saving of £90,000 in one Centre. This sum represents about half

the cost of the Centre's free-standing IVF programme which carries out 130-150

cycles of treatment a year. If it is considered to be appropriate to extrapolate these

figures to the rest of Scotland, then the overall saving in tubal surgery cases for the

whole of Scotland would not be far short of £1,000,000. This is also, however, an

extremely conservative estimate.

Other Savings

176 In addition to the specific issue of tubal surgery, the Working Group believe

that the implementation of this Report, with its emphasis on clear hnes of referral

accuracy and savings may not be immediately apparent. Howev

Infertility Investigation and Management, currently being initia

should go some way to quantifying these savings in the future.

177 The Working Group conclude that it would be possible to

funded IVF service in all 4 Level III centres at an initial cost of

£2m. The rationahsed use of tubal surgery could achieve saving

future years.

The Costs of IVF Compared with the Costs of Other Procedures

178 Page (1989)^' compared the cost of IVF with that of other

out in the NHS. The results were as follows:

Cosis of Procedures

Haemodialysis at home

Renal Transplant

Heart Transplant

Coronary Artery By-Pass

Hip Replacement

IVF (treatment, 3 cycles)

IVF (cost per maternity)

179 These figures illustrate that IVF (at 1989 prices) is not ver

compared with some other procedures. Moreover, Page and Br

out that, when looked at in terms of cost per quality adjusted l

where the benefit is assumed to accrue to the child, the cost pe

compares favourably with other medical procedures.

180 Any costs associated with infertility treatment must be wa

acknowledged to be a very distressing and emotionally debilita

can have damaging side-effects such as a high incidence of acut


! I

Dalton and Lilford (1989) indicate that the value which the general public and the

infertile place upon having a child exceeds the value of a few extra years at the end

of life.''" Edwards and Brinsden et al (1989)'" conclude that it is impossible to put a

price on a healthy, happy family, or the benefit to society of producing wanted

children raised in a caring environment.

Principles of Investigation and Treatment

1 Every involuntarily infertile couple should be entitled, where

receive a proper and well-ordered investigation leading, where p

diagnosis and treatment under the general provision of the Nati

Service, (paragraph 166).

2 At Level I, the management of infertility should commence w

a well-defined initial plan of investigation agreed between the g

and the local gynaecological department, (paragraph 159).

3 At Level II, in order to effect the most efficient use of resour

should be limited to that which is most likely to lead to realistic

treatment. The plan of investigation should contain a specific en

both the nature and the extent of the treatment is fully compreh

couple concerned, (paragraph 100).

4 The management of infertility lends itself to a systematised a

The use of protocols should be mandatory and applicable to all

element of flexibility should be present, however, to permit thei

application. These protocols should be subject to review and up

basis, (paragraph 103).

5 In the long term, by appropriate new or replacement consult

or by the mutually agreed adjustment of existing consultant sess

department should possess an appropriate number of consultant

interest in infertility to conduct infertility clinics where all the p

infertility care detailed in this report can be practised, (paragrap

• 54

6 At Level III, facilities offering IVF and GIFT should be restri

centres in the 4 Scottish cities where there is appropriate labora

facilities for embryo cryostorage, (paragraph 164).

a.


122).

infertility, (paragraph 142).

8 In vitro fertihsation should be offered by the NHS to women up to and

including 40 years of age. Unless there are extenuating circumstances, unexplained

infertility should be of at least 4 years duration by the time that treatment begins,

(paragraph 123).

9 Unless exceptional circumstances dictate to the contrary, women who have had

failed reversal of sterilisation and/or women with responsibihty for at least 2

children within their present relationship should not be eligible for infertility

treatment within the NHS, (paragraph 123).

10 Patient selection criteria should be subject to regular review, (paragraph 124).

11 Patients with blocked fallopian tubes may be treated by either IVF or tubal

surgery. Assessment to decide which procedure is indicated should be performed in

a centre that conducts both IVF and tubal surgery, (paragraph 114).

Laboratory Services

12 Laboratory staff involved in the processing of complex and expensive tests

relating to the investigation and treatment of infertility should be fully consulted at

all stages to permit a full exchange of information to take place on each individual

case, (paragraph 129).

Quality of Care

17 The management of infertile couples should be handled wi

all levels of care so that full cognisance is taken of emotional n

are made to reduce levels of stress, (paragraph 64).

18 Patient literature on the investigation and treatment of infe

prevention, should be made widely available through GP surger

local support groups and public libraries, (paragraph 82).

19 Trained counsellors should be made available in sufficient

adequate counseUing of infertile couples at all levels of care (pa

There is now a statutory requirement to provide counselling pr

insemination and IVF treatment.

20 Couples should be made aware of the imphcations and like

particular process and be able to reach an informed rational de

each successive stage of treatment, (paragraph 89).

21 Each GP practice should receive information from the Hea

availability of services at local and national level, current waiti

data, (paragraph 83).

13 Clinics and seminology laboratories should as far as practicable offer a service

to ensure that infertile couples are tested at the appropriate time, (paragraph 133).

22 The investigation of infertility should involve both partner

(paragraph 100).

• 56

14 Highly specialised tests should be restricted to specialist centres employing

sub-specialists in reproductive medicine or clinicians with a special interest or

expertise in reproductive medicine, (paragraph 134).

15 The possibility of rationalising existing laboratory resources should be

explored, (paragraph 136).

23 The General Practitioner or a member of his team should

key worker to assist couples throughout the entire treatment p

achieve continuity of care (paragraph 71).

24 Careful attention should be paid to the recording of data a

communication between clinicians so as to avoid unnecessary d

of data collection and testing, (paragraph 100).


166).

REFERENCES

Future Reviews

26 The Working Group endorse the intention of the Department of Health and

the Human Fertilisation and Embryology Authority to monitor the use of GIFT,

(paragraph 44).

27 The continued development of infertility services should be kept under review.

An advisory committee of experts convened by, and reporting to, CRAG should

meet on a regular basis for this purpose, make recommendations which could be

included in local protocols, and form an audit group for infertility services in

Scotiand, (paragraph 168).

1 Owens D J, Read M W. Patients experience with an assessm

testing and treatment. Journal of Reproductive and Infant Ps'ycli

2 Bromham D R, Balmer B, Clay R and Hamer R. Disenchant

infertility services: a survey of patients in Yorkshire. British Jou

Planning 1988; 14: 3-8.

3 Davies P. Failing the infertile. The Health Service Journal, 7

4 Laurance J. A fertile dispute. Neiv Society, 4 December 1987

5 The National Association for the Childless (Scotland). Scotti

Services: An Appraisal. NAC (Scodand) 1988.

6 The National Association for the Childless (Scotland). The O

Management of Infertility. [A submission presented to the Work

Infertihty Services in Scotland]. NAC (Scotiand) 1989.

7 Page H. The increasing demand for infertility treatment. He

November 1988.

8 Hull M G R, Glazener CMA, Kelly N J et al. Population s

treatment and outcome of infertility. British Medical Journal. 19

9 Pfeffer N and Quick A. Infertility Services: A Desperate Cas

Greater London Association of Community Health Councils, 19

10 Menning B E. The Emotional Needs of Infertile Couples. F

1980; 34/4: 313-319.

• 58

11 Templeton A, Fraser C, Thompson B. The epidemiology of

Aberdeen. British Medical Journal. 1990; 301: 148-152.


HFEA, 1992.

14 The Voluntary Licensing Authority: The Fifth Report of the Voluntary

Licensing Authority for Human In Vitro Fertilisation and Embryology. London:

VLA, 1990.

15 The National Health Service in Scotland. The Patient's Charter: A Charter for

Health. Edinburgh: HMSO, 1991.

16 Daniluk, J C. Leader A and Taylor P J. Psychological and Relationship

Changes of Couples Undergoing an Infertility Investigation: Some Implications for

Counsellors. British Journal of Guidance and Counselling 1987; 15/1: 29-36

25 Guzick D S. Rock J A. A comparison of danazol and conser

the treatment of infertility due to mild or moderate endometriosi

Sterility 1983; 5:580-583.

26 Seiier J C, Gidwani G, Ballard L. Laporascopic cauterization

for fertility, a controlled study. Fertility and Sterility 1986; 46:10

27 Interim Licensing Authority: The Sixth Report of the Interim

Authority for Human In Vitro Fertilisation and Embryology. Lo

28 Tan S L. Royston P. Campbell S et al. Cumulative concepti

rates after in vitro fertilisation. Lancet 1992; 339: 1390-1394.

17 Warnock M. A question of hfe. Oxford. Basil Blackwell, 1985.

18 The British Medical Association Surogacy Report. London: BMA; 1990

29 Mills M S, Eddowes H A, Cahill D J et al. A prospective co

in vitro fertilisation, gamete intra-fallopian transfer and intraute

combined with superovulation. Human Reproduction 1992; 7:49

m

• 60

19 Mordel N, Mor-Yosef S. Margalioth E J. Spermatic vein ligation as treatment

for male infertility: justification by postoperative semen improvement and

pregnancy rates. Journal of Reproductive Medicine 1990; 35:123-127

20 Takihara H. Sakatoku H. Cockett A T K. The pathophysiology of varicocele

in male infertility. Fertility and Sterility 1991; 55:861

21 Okuyama A. Fujisue H. Matsui T. Surgical repair of varicocele: effective

treatment for subfertile men in a controlled study. European Urology 1988;

14:298-300

22 Hull, M G R, Savage P E, Jacobs H S. Investigation and treatment of

amenorrhoea resulting in normal fertility. British Medical Journal 1979; I:

1257-1261

23 Braat D D. Schoemaker R, Schoemaker J. Life table analysis of fecundity in

intravenously gonadotrophin-releasing hormone-treated patients with

normogonadotropic and hypogonadotropic amenorrhoea. Fertility and Sterility

1991; 55:266.

30 Dawson K J, Rutherford A J, Margara R A, Winston R M

pregnancies following in vitro fertilisation Lancet 1991, 337: 15

31 Abdalla HI. Active management of infertility. British Journa

Medicine 1992; 48/1: 28-33.

32 Buchan H, Vessey M. Trends in hospital discharge rates for

inflammatory disease in Scotland, 1975-1985 Health Bulletin 199

33 Botting B, Macdonald Davies I, Macfarlane A. Recent trend

of multiple births and associated mortality. Archives of Disease

62: 941-950.

34 Ashkenazi J, Ben David M, Feldberg D, et al. Abdominal c

following ultrasonically guided percutaneous transvesical collect

in vitro fertilisation. Journal of In Vitro Fertilisation and Embryo

316-318.

35 Congress of the United States, Office of Technology Assessme

Medical and Social Choices. Washington DC: US Government Pri


University of York; Research Unit, Royal College of Physicians. Effective Health

Care: The Management of Subfertility. University of Leeds, 1992

38 Page H. Economic appraisal of in-vitro fertilisation: discussion paper. Journal

of the Royal Society of Medicine 1989; 82: 99-102.

39 Page H and Brazier J. Benefits of In-Vitro Fertilisation. Lancet 1989; 334:

1327-1328.

40 Dalton M, Lilford R J, Benefits of in-vitro fertilisation. Lancet 1989; 334: 1327.

41 Edwards R G, Brinsden P, et al. Benefits of in-vitro fertihsation. Lancet 1989;

334: 1328.

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Chairman

Dr A Ford

Members

Professor A Calder

Consultant Paediatrician

Royal Hospital for Sick Children

Consultant Obstetrician and Gynaecologist

Centre for Reproductive Biology, Edinburgh

NAME

MAIN HOSPITAL

Summ

YE

(1) ARE INFERTILITY PATIENTS GIVEN PRIORITY 10

APPOINTMENTS?

Dr S K Cole

Dr G Gordon

Dr M H Hall

Consultant in Public Health Medicine

Information and Statistics Division,

Common Services Agency, Edinburgh

Consultant Obstetrician and Gynaecologist

Dumfries and Galloway Royal Infirmary

Consultant Obstetrician and Gynaecologist

Aberdeen Royal Infirmary

(2) IS A SEVEN DAY PER WEEK FACILITY PROVIDED? 16

(3) IS THE MALE PARTNER POSITIVELY

ENCOURAGED TO ATTEND?

(4) ARE PATIENTS GIVEN AN INVESTIGATION

AND/OR TREATMENT PLAN?

(5) ARE THERE LOCAL 'PATIENT SUPPORT' GROUPS 23

32

29

Dr M Hulse

Consultant Obstetrician and Gynaecologist

Raigmore Hospital, Inverness

(6) IS THERE SPECIFIC 'INFERTILITY'

NURSE INPUT 15

• 68

Dr B Potter

Dr R J Simpson

Dr R Smith

Dr M Whittle

Secretariat

Dr R E G Aitken

Mr J N Leadbeater

General Practitioner, Edinburgh

General Practitioner, Bridge of Allan

Consultant Obstetrician and Gynaecologist

Ninewells Hospital, Dundee

Consultant Obstetrician and Gynaecologist

The Queen Mother's Hospital, Glasgow

Senior Medical Officer, SHHD

Principal Administrative Assistant, SHSAC

(7) IS THERE NON-MEDICAL COUNSELLING

(eg SOCIAL WORKER, LOCAL VOLUNTEER) 11

BEFORE AND/OR AFTER REFERRAL? SPECIFY ..

(8) DOES THE GP HAVE A PRE-REFERRAL

PROTOCOL 4

(9) DOES THE GP RECEIVE AN INVESTIGATION

AND/OR TREATMENT PLAN? 20

Results have not been numerically summarised for the remainde

questionnaire due to the complex nature of the responses. An ac

findings of the questionnaire is given in Chapter III.


B.B.T CHARTS

MIDLUTEAL

PROGESTERONE(S)

URINE ANALYSIS

AND M.S.U.

F.B.C.

RUBELLA STATUS

CHLAMYDIA STATUS

STATUS

HORMONE

PROFILE(S)

HEIGHT/WEIGHT

ENDOMETRIAL

BIOPSY

LH SURGE

ASSAY(S)

CYCLE HORMONE

PROFILE(S)

CYCLE FOLLICLE

SCANS

HYSTERO

-SALPINGOGRAM

LAPAROSCOPY

SPERM INVASION

TEST(S)

CROSS HOSTILITY

TEST(S)

ANTISPERM

ANTIBODY TEST(S)

MALE

FACTORfSj

SEMEN ANALYSIS (ES)

BACTERIOLOGY

HORMONE ASSAY

(L.H., FSH,

TESTOSTERONE)

ALWAYS OFTEN OCCASION

IS THERE A CLINIC PROTOCOL FOR

SEMINAL COLLECTION AND INSPECTION?

IS THE COUNT ROUTINELY REPEATED

YES

YES

HOW IS "UNEXPLAINED" INFERTILITY IN THE FOLLOW

MANAGED:-

a. WITH MILD ENDOMETRIOSIS

b. WITH POOR MUCUS TESTS

• 70

AVERAGE WAITING FROM DECISION TIME TO

OPERATION WEEKS FOR EITHER/BOTH

c. WITH NO OBSERVED ADVERSE FACTORS


ANOVULATION

CLOMID +-HCG

OR CYCLOFENIL)

Subspecialist

Centre

IF APPROPRIATE, TO WHICH SPECIALIST CENTRE ARE

PATIENTS USUALLY REFERRED FOR A.I.D. (D.I.)

IF APPROPRIATE, TO WHICH SPECIALIST CENTRE ARE

PATIENTS USUALLY REFERRED FOR ASSISTED

CONCEPTION (I.V.F., G.I.F.T etc)

H.M.G. + H.C.G.

(eg

Glasgow Royal Infirmary, Edinburgh Royal Infirmary, N

Aberdeen Royal Infirmary, Private or other)

METRODIN

DOWN REG.c- LHRH

+HMG

IF YOUR HOSPITAL OR AREA IS UNABLE TO PROVIDE A

ABOVE FORMS OF INVESTIGATION OR TREATMENT W

CONSIDERED?

i. DESIRABLE

TUBAL

ii.

NECESSARY

TUBAL SURGERY

ANY OTHER COMMENTS ABOUT THE LEVEL OF PROVI

SERVICE IN YOUR HOSPITAL/AREA, PRESENT OR FUTUR

MICROSURGERY

ASSISTED CONCEPTION

G.I.F.T.

I.V.F.

ANY OTHER COMMENT ABOUT INFERTILITY SERVICES

SCOTLAND.

Other

MALE PARTNER

A.I.D. (D.I.)

• 72


Androgens Hormones influencing the development and function of male sexual

organs and the secondary sexual characteristics of the male.

Andrologist An expert in male infertility and endocrine problems.

Artificial insemination Introduction of sperm into the female genital tract by means

other than sexual intercourse using semen from the husband or from a donor.

Hyperprolactinaemia Elevated blood concentrations of the hormo

which may result in the inappropriate secretion of milk and prev

Hypothalamus Part of the forebrain which contains nerve centre

of certain vital processes including genital functions.

In-vitro fertilisation (IVF) A technique used in assisted reproduct

fertiUsation of the female sex cell by a male sex cell in a glass di

Bromocriptine A drug which reduces concentrations of the hormone prolactin in

the blood.

Laparoscopy A technique for viewing the abdominal cavity by p

instrument through the abdominal wall.

Clomiphene A drug that stimulates ovulation or the production of ova through the

medium of the pituitary gland.

Ectopic Pregnancy A pregnancy which implants outside of the womb.

Embryo A term used to describe the very early fetus.

Endometriosis A condition in which the cells of the type lining the interior of the

womb are found in other parts of the body.

Oestradiol A hormone secreted from the ovary which is responsi

development of the female sexual characteristics and for part of

take place in the uterus before menstruation.

Oligospermia A diminished output of sperm.

Oocyte The immature egg cell or ovum in the ovary.

Ovulation The process of rupture of the mature Graafian foUicl

shed from the ovary into the womb.

Endometrium The lining of the interior of the womb.

Erythrocyte Sedimentation Rate (ESR) The rate at which red blood cells form a

deposit in a graduated 200 mm tube.

Gamete A sex cell (ie sperm or oocyte) which combines with another to form a

single fertilised cell.

Gamete intra-fallopian transfer (GIFT) A technique used in assisted reproduction in

which spermatozoa and oocytes are placed in the fallopian tube thereby enabling

fertilisation to occur in vivo.

Pituitary gland An endocrine gland whose function is to secrete

play an important part in general chemical changes or the activi

at a distance.

Polycystic ovarian syndrome Enlarged cystic ovaries.

Progesterone A hormone which is elevated when ovulation has o

Prolactin A milk producing hormone which stimulates the breas

Spermatozoa Generative cells which form the essential part of se

• 74


Vasectomy Surgical operation involving removal of part of the vas deferens - a

duct conveying semen along the spermatic cord - to render men sterile.

Zygote intra-fallopian transfer (ZIFT) A technique used in assisted reproduction in

which a single fertilised cell is placed in the fallopian tube.

Zygote A single fertihsed cell formed from two gametes.

INTRODUCTION TO THE INFERTILITY CLINIC

Infertility is a common problem affecting at least 1 in 10 of all m

you have been referred to our clinic, it is likely that either you o

suspected that there may be a problem in this area and we very

can help resolve the situation. At this stage, it may be little com

you should know that you are not alone and that your problem

common. Infertility occurs equally in men and women and can o

those who have had or been responsible for a previous pregnanc

discover a clear cut reason, but sometimes there are a combinati

nothing very definite is found.

This document is designed to help you through the initial assess

give you some indication of what you might expect at the Clinic

help to us if you could complete the accompanying questionnaire

confirm that you are going to attend the Clinic and thus keep th

you have difficulty with some of the questions, please do not wo

Please remember that the purpose of the Clinic is to help you an

uncertain or unhappy about anything, please discuss this with th

infertility nurse. Never be afraid to ask questions!

initial Assessment

We always attempt to see both partners at the initial visit and w

thereafter. It is therefore important that you both attend so that

you both the relevant questions. Information about previous illn

is very useful, and if you have completed the questionnaire and

part can be covered very quickly. After you are both asked the r

the doctor will carry out a physical examination. This does not

few minutes for each partner. For women it is useful to know w

smear was last taken.

• 76


• 78

after the initial assessment. If more tests are required the doctor will explain their

reason. A full instruction sheet about handing in sperm specimens will be given to

you at the Clinic.

Hormone tests

An arrangement will be made for the woman to have blood taken during the

second half of the month. In this blood test we measure hormones to confirm that

ovulation is occurring, and also take the opportunity to check on general health

and German Measles. Usually one blood sample is sufficient.

Second Visit

At the second visit you will both be given the results of these tests and the next

step will be discussed at that stage. If these tests are normal, we usually

recommend that the woman comes in for a small operation to check that her tubes

are normal. This procedure involves being in hospital for 1-2 nights. It is done

under general anesthetic and a small telescope is used to look at the tubes directly,

but more information will be given about this if and when the time comes.

Subsequent Visits

Other tests are organised as needed and these will be explained to you as you go

along. Similarly, any treatment that is started will be fully explained to you.

TUBAL SURGERY

Your infertility investigations have indicated that tubal surgery may be an option

in an attempt to improve your chances of conceiving. While you are considering

this matter, and before you come to a decision, there are some facts you should

know:

1. This is a major operation, lasting 2-3 hours, and involves a large incision

in your abdomen.

2. You will be in hospital 5-10 days.

79

5. If the operation is successful and you become pregnant, y

increased risk of ectopic pregnancy. This would involve anot

operation for removal of the tube and the pregnancy.

6. This operation is technically more difficult if you are ove

may be asked to lose weight before you are placed on the w

All these factors, and others, will be fully discussed with you bot

Clinic.

REVERSAL OF STERILISATION

As you are enquiring about reversal of sterilisation there are som

should know.

Before proceeding further, it is essential that both you and your

potential fertility checked. For the woman this involves blood tes

ovulation. For the man it will be necessary to check two semen s

If these tests are all normal and the doctor feels in your circumst

of sterilisation is feasible, then it it is sometimes necessary for the

undergo a laparoscopy so that the state of the fallopian tubes can

is important, as the amount of tube remaining gives an indicatio

successful the operation might be. There is usually a waiting tim

for this investigation, which involves 2 nights in hospital.

Should the doctor decide to go ahead with your reversal of steril

some important facts you should know:

1. The success rate can be quite low, anything from 10-70%

2. The operation is considered to be a major one, involving

the abdomen, and reconstruction of the tubes.

3. You will be in hospital for 5-10 days.


pregnancy.

6. Technically this operation is more difficult if you are overweight, and you

may well be asked to lose weight before you are placed on the waiting list.

All these factors, and others, will be fully discussed with you both by the doctor.

CLOMIPHENE

Your infertility investigations show that you may benefit from C

in an attempt to help you conceive.

The dosage of this drug will be closely monitored by the Inferti

must NEVER increase the dosage without direct instruction fro

any questions or problems with your treatment, please 'phone th

LAPAROSCOPY

The next step in your infertility investigations is now a laparoscopy.

This is a minor operation which will involve you coming into hospital as a day

case or for 1-2 nights.

This investigation can be carried out at any time during your cycle except when

you are menstruating. The ward staff will be in touch with you by letter to find

out roughly when you expect your periods. It is important that during the cycle,

when you have your laparoscopy, that you avoid the risk of pregnancy, in other

words, you should use contraception.

The operation is carried out under general anaesthetic. A small incision is made

under your umbilicus through which a telescope is passed. Through this telescope,

the doctor is able to look at your ovaries and fallopian tubes. He will pass some

dye through your tubes to check that they are open. This operation normally takes

about 15 minutes. You come out of hospital the day after your operation and can

normally return to work after 48 hours.

Approximately 8-10 weeks after your operation, you will receive an appointment to

return to the Infertility Clinic to discuss the results.

It is normal to start Clomid on the second day of your period,

have periods then the clinic will take a blood test for you to che

levels, and give you a date to start the tablets.

The initial dose of Clomid is one tablet (50mg) from day 2 to d

You then have to come back to the Infertility Clinic on day 21

another blood test to check if you have ovulated. You 'phone in

for the result of that blood test and further instructions. Occasio

arrange for these blood tests to be done by your GP, but this m

difficult for us to receive the result in time for us to adjust the

next cycle.

You should note that this treatment is more likely to be effectiv

overweight nor underweight.

As Clomiphene is a "fertility drug" you will have a slightly incr

pregnancy.

POSTCOITAL TEST

The next step in your infertility investigations is a post-coital te

determine how well the sperm can penetrate, and survive in, the

• 80

If you have any other questions or concerns, please do not hesitate to discuss these

with the clinic Sisters.

81

The result of a PCT are only valid if the test is carried out at th

cycle when you are about to ovulate.


• 82

next morning for your PCT. Your husband is welcome to attend with you.

Please 'phone the Clinic when your next period starts so that the timing for your

PCT can be arranged.

It is important that you abstain from intercourse from when you first start

attending for blood tests.

ENDOMETRIAL BIOPSY

The aim of this procedure is to obtain a sample of the lining of the womb, which

is normally shed during menstruation.

It involves an examination similar to getting a smear, except a small flexible tube

is passed into the womb and a sample of lining is removed by suction. This

procedure is relatively painless but you may experience mild "period-like"

discomfort for a minute or two. It is normal to have some light bleeding

afterwards.

The procedure itself only takes about 5 minutes. It would be advisable to bring a

companion with you who could accompany you home.

DONOR INSEMINATION (Dl)

Patient Information Sheet

It is thought that each year thousands of couples will seek treatment by DI. The

need appears to be increasing as adoption prospects diminish and DI gains

acceptance and wider publicity.

Treatment by DI is commonly recommended when the woman is found to be

normally fertile and the husband is found to be substantially infertile, or to be the

carrier of an hereditary disease which the couple do not want passed on to the

child.

implications of the treatment and are happy about undergoing it.

explanation and counselling are then offered by the nursing staff

programme.

Confidentiality

At present, your donor insemination notes are kept separately fro

hospital file and in such a way that confidentiality is preserved. T

donor is kept strictly confidential so that you cannot learn his id

may if you wish obtain some non-identifying information about h

your name will not be known to the donor.

Selection of Donors

The selection of donors is very carefully controlled. We pay parti

the health and potential fertility of the donor, as well as to the a

sexually transmissible diseases. As far as is possible, we try to ex

possible hereditary illness by taking a very detailed family history

select donors who have a fair level of intelligence.

In accordance with Government guidelines, all donors are tested

infection and hepatitis about every 6 months, and semen is kept

the second test is known to be negative. This is not a guarantee

be passed on through donor insemination, but the likelihood of t

extremely remote. To comply with Government guidelines, all se

donor insemination will be stored in a frozen semen bank.

The identity of the donor is strictly confidential, and neither the

recipient will know the identity of the other.

Matching of Donors

Where possible, we try to use a donor who has similar characteri

partner. Race, blood group and eye colour are the major conside

and whilst details such as hair colour and build are taken into ac

possible, it is unwise for a couple to expect exact matching in thi

from different ethnic groups are kept separately.


• 84

patterns. If blood tests are necessary, these will be done here at the Infertility

Clinic at 8.00-8.40am each morning, and you should be kept for no more than 10

minutes. If urine testing at home seems advisable, then this can be done using one

of the commercially available urine testing kits, which we can supply you with at a

reduced cost.

When ovulation is expected, you will be asked to return to the clinic that

afternoon, with your partner if you wish, for your treatment. The actual

insemination is quite simple and painless. The midwife gently inserts an instrument

(a speculum) into the vagina in order to place semen in the mucus at the neck of

the womb (the procedure is very similar to having a smear taken). A short rest

follows. Sexual intercouse can continue as normal during the treatment cycle unless

you are advised against this.

Initially you will be offered a course of 6 cycles of treatment. The pregnancy

success rate at the end of this number of cylces of treatment is expected to be

around 50%. During these initial 6 cycles, your treatment will be continually

assessed.

Once conception has been confirmed, the pregnancy should follow a normal

course. There is no lower or higher risk of miscarriage, tubal pregnancy or of

congenital abnormality than when conception occurs naturally.

Counselling

You and your partner will be given detailed information about the process of

insemination. The implications of this treatment for yourselves, your family and

any other children will be discussed. The welfare of the child will be an important

issue. You will have an opportunity to reflect on this decision before making your

decision. If you feel you need further discussion or support, please ask, and it will

be arranged.

Coming to terms with infertility can be very difficult and it is essential that

treatment by DI is very carefully considered and your joint decision is not hurried.

As far as possible you should both try to anticipate your own reaction to the

clinic who is available to discuss matters with you if you wish i

LegalAspects

Under the terms of the Human Fertihzation and Embryology A

Human Fertilization and Embryology Authority (HFEA) regulat

centres which practice donor insemination. Any child resulting

insemination treatment may be registered legally as the child of

partner. The personal details of all donors used are registered w

that non-identifying information may be made available to offs

(see below).

Consent

Both partners must consent in writing to the procedure.

Telling Your Child?

Although you will be encouraged to tell your child about his/he

insemination, whether or not you choose to do so is a very pers

which you as a couple must make. We will of course respect yo

regard.

If you do choose to tell your child, he or she will have the righ

age of 18, and upon application to HFEA after appropriate cou

about his/her origin by donor insemination. Non-identifying in

donor may be made available to the child.

Costs

Unfortunately, the National Health Service is unable to meet fu

providing this service, and we are therefore obliged to ask patie

contribution towards the costs of keeping the programme going

on the attached sheet.

In addition, HFEA levy a registration fee per cycle treated, and

locally is not in a position to meet this. Regretfully therefore, w

alternative but to pass this cost on.


Pfeffer N and Quick A: Infertility Services: A Desperate Case. London:

The Greater London Association of Community Health Councils, 1988.

Jones M: Trying to Have a Baby? Overcoming Infertility and Child Loss. Sheldon

Press, 1984.

Benady S: How to Choose a Test Tube Baby Clinic. London: The Independent,

1989.

Glover J: Fertility And the Family: The Glover Report on Reproductive

Technologies To The European Commission. London: Fourth Estate, 1989.

Belhna J and Wilson J: The Fertility Handbook: A Positive And Practical Guide.

Penguin, 1986.

The Human Fertilisation and Embryology Authority Annual Report, HFEA,

London, 1992.

Statistical Analysis of the United Kingdom IVF and GIFT Data, 1985-1990, HFEA,

London, 1992.

School of Public Health, University of Leeds; Centre for Health Economics,

University of York; Research Unit, Royal College of Physicians. Effective Health

Care: The Management of Subfertility. University of Leeds, 1992.

Royal College of Obstetricians and Gynaecologists. Infertihty: Guidelines for

Practice. RCOG, London, 1992.

British Agencies for Adoption and Fostering

40 Shandwick Place, Edinburgh EH2 4RT

Tel: 031-225 9285

This organisation offers guidance to prospective persons seeking

and aims to establish good practice in adoption.

British Pregnancy Advisory Service

Head Office: Austy Manor, Wootten Wawen, Solihull, West Mi

Tel: 0564 793225

The British Pregnancy Advisory Service (BPAS) is a non-profit m

limited by guarantee with some 20 branches spread throughout

these branches is located in Scotland (see below). Treatment for

available at a number of specialist centres and includes artificial

reversal of male and female sterilisation.

Scottish Branch:

British Pregnancy Advisory Service

245 North Street, Glasgow.

Tel: 041 204 1832

Child

367 Wandsworth Road, London SW8 2JJ

Tel: 081 740 6605

This is an independent voluntary organisation which assists in d

into infertility and helps to educate the public in methods of ov

of infertility. The organisation offers a 24-hour answering servic

newsletter and a series of factsheets on infertility, including ado

• 86

Family Care

21 Castie Street, Edinburgh EH2 3DN

Tel: 031-225 6441


27-35 Mortimer Street, London Wl.

Tel: 071 636 7866

This association provides advice and support to childless couples

number of self-help groups. It also publishes a regular newsletter

on services for the infertile.

The Family Planning Information Service provides a personal enquiry service to the

general pubhc on matters relating to contraception and infertility also offers advice

and information on infertility.

The Human Fertilisation and Embryology Authority

Paxton House, 30 Artillery Lane, London El 7LS.

Tel: 071 377 5077

The Human Fertilisation and Embryology Authority is a statutory body established

under the Human Fertilisation and Embryology Act 1990 to regulate the field of

assisted conception. The Authority is required to operate a licensing system for all

centres carrying out one or more of the following activities:

- storage of gametes of embryos;

- research on human embryos;

- any infertility treatment which involves the use of donated gametes; and

- any treatment which involves the creation or use of embryos outside the

body.

The Authority is empowered to issue 3 kinds of licence - for treatment, for storage,

or for research.

A second major function of the Authority is to maintain a central register of all

such treatments given, of all people born as a result of treatment, and of all

donors.

The Authority has a number of other statutory duties. These include publicising

the services which it provides and those which licensed centres provide and

publishing a Code of Practice giving guidance to centres on how they should carry

out their licensed activities.

Scottish Branch:

Issue - (The National Fertility Association) (Scotland)

21 Castie Street, Edinburgh EH2 3DN.

Tel: 031 225 2464

The Miscarriage Association

18 Stoneybrook Close, West Bretton, Wakefield WF4 4TP

Tel: 0924 830515

This association provides support through local groups nationwi

newsletter and a number of factsheets.

The National Foster Care Association

Leonard House, 5-7 Marshallsea Road, London SEl lEP

Tel: 071-828 6266

The National Foster Care Association provides information and

people who wish to foster children.

Pregnancy Advisory Service

11-13 Charlotte Street, London WIP IHD

Tel: 071-637 8962

The Pregnancy Advisory Service (PAS) is a non-profit making or

provides a service offering artificial insemination using donated

offer advice on infertility.

Progress

27-35 Mortimer Street, London, WIN 7RJ

Tel: 071 436 4528


Tel: 031 553 5060

This Association provides a service in placing children between 0-8 years to

couples within a 60 mile radius of Edinburgh.

The Scottish Adoption Advice Service

16 Sandyford Place, Glasgow G2

Tel: 041-339 0772

t

This centre offers advice to couples who wish to adopt children.

Twins and Multiple Births Association

292 Valley Road, Lillington, Leamington Spa, Warwickshire CV32 7UE

This association provides support and help to parents who have triplets (or more)

and a series of local clubs nationwide for the parents of twins.

Printed by HMSO, Edinburgh Press

Dd 287568 C15 3/93 (208493)

• 90


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