Eighth Edition - R.3 - Human Fertilisation & Embryology Authority

Mandatory requirements (cont)
T89
(cont)
b. any information derived from tests on an embryo, or any material removed from it or from
gametes that produced it, is not used to select embryos of a particular sex for social reasons
c. before the people seeking treatment give consent to preimplantation screening of embryos
for aneuploidy they must be given an oral explanation supported by relevant written material:
i. of the risks associated with the preimplantation screening for aneuploidy
ii.
iii.
iv.
of the unproven nature of the procedure, in particular that more robust clinical and
laboratory trials are needed to assess whether or not PGS can significantly increase live
birth rates for different specific indicators and it is likely that the method of fluorescent
in situ hybridisation (FISH) on embryos, using a limited number of chromosomes, is not
effective at increasing live birth rates
that embryos that have been biopsied may not be available for cryopreservation and for
use in subsequent treatment cycles
of the misdiagnosis rates associated with the preimplantation screening for aneuploidy,
including that the misdiagnosis rates can be positive or negative
v. that the more chromosome tests that are used, the higher the technical failure rate, and
the lower the chance of finding suitable embryos for transfer
vi. that there is no guarantee against a miscarriage occurring, despite PGS for aneuploidy
being performed
vii. of the costs of treatment both financially and emotionally in the context of the chance of
not taking home a baby following preimplantation screening for aneuploidy, and
viii. that counselling is available.
d. they monitor the latest literature and professional guidance in order to validate the use of PGS
for each category of patients to which they offer it. Validation should also be based on data
from previously published studies and retrospective evaluation of their own data.
HFEA guidance
The use of PGS
Interpretation of mandatory requirements
An embryo may be tested to establish whether it has a particular chromosomal abnormality only if:
9A
(a)
(b)
that abnormality may affect its capacity to result in a live birth, or
there is a particular risk that it has that abnormality, and where the Authority is satisfied that there is
a significant risk that a person with that abnormality will have or develop a serious medical condition.
See also guidance note:
10 – Embryo testing and sex selection
Human Fertilisation and Embryology Authority
Guidance note | 9. Preimplantation genetic screening (PGS)
Version 1.0