10. Embryo testing and sex selection

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Refer to principles 5, 7 and 9

Regulatory principles that apply to licensed centres

  • 5.

    provide prospective and current patients and donors with sufficient, accessible and up-to-date information in order to allow them to make informed decisions;

  • 7.

    conduct all licensed activities with proper skill and care and in an appropriate environment, in accordance with good clinical practice, to ensure optimum outcomes and minimum risk for patients, donors and offspring;

  • 9.

    ensure that all staff engaged in licensed activity are competent and recruited in sufficient numbers to guarantee safe clinical and laboratory practice;

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Human Fertilisation and Embryology (HFE) Act 1990 (as amended)

Schedule 2 - Activities that may be licensed under the 1990 Act

Licences for treatment

Embryo testing

  • 1ZA

    (1) A licence … cannot authorise the testing of an embryo, except for one or more of the following
    purposes–

    (a) establishing whether the embryo has a gene, chromosome or mitochondrial abnormality that may affect its capacity to result in a live birth,

    (b) in a case where there is a particular risk that the embryo may have any gene, chromosome or mitochondrion abnormality, establishing whether it has that abnormality or any other gene, chromosome or mitochondrion abnormality,

    (c) in a case where there is a particular risk that any resulting child will have or develop –

    (i) a gender-related serious physical or mental disability,

    (ii) a gender-related serious illness, or

    (iii) any other gender-related serious medical condition, establishing the sex of the embryo,
    ...

    (e) in a case where uncertainty has arisen as to whether the embryo is one of those whose creation was brought about by using the gametes of particular persons, establishing whether it is.

    (2) A licence… cannot authorise the testing of embryos for the purpose mentioned in sub-paragraph (1)(b)
    unless the Authority is satisfied–

    (a) in relation to the abnormality of which there is a particular risk, and

    (b) in relation to any other abnormality for which testing is to be authorised under sub-paragraph

    (1)(b), that there is a significant risk that a person with the abnormality will have or develop a serious physical or mental disability, a serious illness or any other serious medical condition.
    (3) For the purposes of sub-paragraph (1)(c), a physical or mental disability, illness or other medical
    condition is gender-related if the Authority is satisfied that –
    (a) it affects only one sex, or
    (b) it affects one sex significantly more than the other.

Licence conditions

  • T86

    Embryos that are known to have a gene, chromosome or mitochondrion abnormality involving a significant
    risk that a person with the abnormality will have or develop:

    a. a serious physical or mental disability

    b. a serious illness, or

    c. any other serious medical condition, must not be preferred to those that are not known to have such an abnormality.

  • T87

    Embryos that are known to be of a particular sex and are known to carry a particular risk, compared with
    embryos of that sex in general, that any resulting child will have or develop:

    a. a gender-related serious physical or mental disability

    b. a gender-related serious illness, or

    c. any other gender-related serious medical condition, must not be preferred to those that are not known to carry such a risk.

  • T88

    With respect to any embryo testing programme involving biopsy the centre must ensure that:

    a. no embryo is transferred to a woman where that embryo or any material removed from it or from the gametes that produced it, has been subject to a test that supplies genetic information about the embryo, unless the test has been expressly authorised by the Authority, and

    b. any information derived from tests on an embryo, or any material removed from it or from the gametes that produced it, is not used to select embryos of a particular sex for social reasons.

  • T89
    With respect to any embryo testing programme the centre must ensure that embryo testing is only being carried out for those genetic conditions that are expressly authorised by the Authority.
  • T91
    Centres may use non-invasive procedures, for example metabolomics, to test and select for the viability of embryos. However, centres must not use these procedures to test for specific gene, chromosome or mitochondrion abnormality without prior authorisation from the Authority.

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Staff to be involved in embryo testing

  • 10.1
    A senior clinical geneticist should be involved in deciding whether a particular patient should receive treatment involving embryo testing.
  • 10.2
    The centre should ensure that a multidisciplinary team is involved in providing the embryo testing service. The team should include reproductive specialists, embryologists, clinical geneticists, genetic counsellors, cytogeneticists and molecular geneticists. It should maintain close contact with the primary care physician or the referring clinician.
  • 10.3
    Treatment should include patient support following embryo testing.

Embryo transfer using biopsied embryos

  • 10.4
    Embryos from which biopsies have been taken, or resulting from gametes from which biopsies have been taken, should not be transferred with any other (non-biopsied) embryos in the same treatment cycle.

Preimplantation genetic diagnosis for heritable conditions

10AInterpretation of mandatory requirements

Preimplantation genetic diagnosis (PGD) can be carried out for a heritable condition only in two circumstances:

  • • where there is a particular risk that the embryo to be tested may have a genetic, mitochondrial or chromosomal abnormality, and the Authority is satisfied that a person with the abnormality will have or develop a serious disability, illness or medical condition, or
  •  • where there is a particular risk that any resulting child will have or develop a gender related serious disability, illness or medical condition. A condition is gender related if the Authority is satisfied that it affects only one sex, or affects one sex significantly more than the other. In the first situation, PGD may be carried out to establish whether the embryo has the suspected abnormality; in the second, PGD may be carried out to establish the sex of the embryo.
  • 10.5

    When deciding if it is appropriate to provide PGD in particular cases, the centre should consider the circumstances of those seeking treatment rather than the particular heritable condition.

  • 10.6
    The use of PGD should be considered only where there is a significant risk of a serious genetic condition being present in the embryo. When deciding if it is appropriate to provide PGD in particular cases, the seriousness of the condition in that case should be discussed between the people seeking treatment and the clinical team. The perception of the level of risk for those seeking treatment will also be an important factor for the centre to consider.
  • 10.7

    The centre should consider the following factors when deciding if PGD is appropriate in particular cases:

    (a) the views of the people seeking treatment in relation to the condition to be avoided, including their previous reproductive experience

    (b) the likely degree of suffering associated with the condition

    (c) the availability of effective therapy, now and in the future

    (d) the speed of degeneration in progressive disorders

    (e) the extent of any intellectual impairment 

    (f) the social support available, and

    (g) the family circumstances of the people seeking treatment.

  • 10.8

    Concerns have been raised about the ethical implications of directly testing embryos for a genetic condition without disclosing the test results to the patients (PGD with non-disclosure).

    Where patients seek PGD, but do not wish to discover their own genetic status, centres should, where possible, only offer PGD with exclusion testing.

  • 10.9

    In exceptional circumstances the centre may offer PGD, but withhold the patient’s test results (PGD with non-disclosure). However, this should only be offered under the following conditions:

    (a) that patients are given the opportunity to receive genetic counselling on the implications prior to giving consent,

    (b) that protocols are established to limit, as far as possible, the risk of unwanted disclosure to the patients. Centres should consider using a different embryology laboratory from their own, in order to minimise the number of centre staff who know the patient’s genetic status, and

    (c) that no dummy embryo transfers are to be performed.

  • 10.10

    The centre should document its reasons for offering PGD with non-disclosure to a patient. This record
    should include:

    (a) written informed consent from the patient to perform PGD with non-disclosure,

    (b) a statement from the people seeking treatment confirming that they have been given the opportunity to receive genetic counselling and that they have, prior to giving consent, received information:

    (i) on the risks of inadvertent disclosure,

    (ii) that where all embryos are suitable for transfer this is not evidence of the patient’s genetic status,

    (iii) that where no embryos are suitable for transfer this is not evidence of the patient’s genetic status,

    (iv) that therefore dummy embryo transfers are not necessary or permissible, and

    (v) that treatment may go ahead which is not medically necessary in cases where the patient (or partner) does not have the genetic condition. This includes information about the potential costs and risks of any medically unnecessary treatments.

Preimplantation genetic diagnosis to establish the identity of gamete providers

10BInterpretation of mandatory requirements

An embryo may be tested to establish whether it was brought about using the gametes of particular people, where this is uncertain.

Genetic consultation and counselling

  • 10.11

    The centre should ensure that people seeking treatment have access to clinical geneticists, genetic counsellors and, where appropriate, infertility counsellors.

  • 10.12

    The centre should work closely with the local genetics team of those seeking treatment.

Information for those seeking preimplantation genetic diagnosis

  • 10.13

    The centre should ensure that people seeking PGD are given the appropriate information about the treatment. This should include:

    a) the process, procedures and possible risks involved in IVF and biopsy procedures when providing a sophisticated genetic test

    b) the experience of the centre in carrying out the procedure.

  • 10.14

    The centre should also provide information to those seeking treatment to help them make decisions about their treatment, including:

    (a) genetic and clinical information about the condition being tested for

    (b) the likely impact of the condition on those affected and their families

    (c) information about treatment and social support available, and

    (d) information from a relevant patient support group or the testimony of people living with the condition, if those seeking treatment have no direct experience of it themselves.

  • 10.15

    If the person seeking treatment has already been given information about the particular genetic disorder, for example from a regional genetics centre, the centre need not provide this information again. However, the centre should ensure that the information has been provided to a satisfactory standard of breadth and clarity.

  • 10.16

    Before providing PGD, the centre should ensure that those seeking treatment have had sufficient opportunity to fully consider the possible outcomes of genetic testing and their implications.

Prohibitions in connection with embryo selection

Mandatory requirements

Human Fertilisation and Embryology (HFE) Act 1990 (as amended)

Section 13

(8) Subsections (9) and (10) apply in determining any of the following –

(a) the persons who are to provide gametes for use in pursuance of the licence in a case where consent is required under paragraph 5 of Schedule 3 for the use in question;

(b) the woman from whom an embryo is to be taken for use in pursuance of the licence, in a case where her consent is required under paragraph 7 of Schedule 3 for the use of the embryo;

(c) which of two or more embryos to place in a woman.

(9) Persons or embryos that are known to have a gene, chromosome or mitochondrion abnormality involving a significant risk that a person with the abnormality will have or develop–

(a) a serious physical or mental disability,

(b) a serious illness, or

(c) any other serious medical condition, must not be preferred to those that are not known to have such an abnormality.

(10) Embryos that are known to be of a particular sex and to carry a particular risk, compared with embryos of that sex in general, that any resulting child will have or develop–

(a) a gender-related serious physical or mental disability,

(b) a gender-related serious illness, or

(c) any other gender-related serious medical condition,

must not be preferred to those that are not known to carry such a risk.

(11) For the purposes of subsection (10), a physical or mental disability, illness or other medical condition is gender-related if–

(a) it affects only one sex, or

(b) it affects one sex significantly more than the other.

Schedule 2 – Activities that may be licensed under the 1990 Act

Sex selection

1ZB

(1) A licence under paragraph 1 cannot authorise any practice designed to secure that any resulting child will be of one sex rather than the other.

(2) Sub-paragraph (1) does not prevent the authorisation of any testing of embryos that is capable of being authorised under paragraph 1ZA.

(3) Sub-paragraph (1) does not prevent the authorisation of any other practices designed to secure that any resulting child will be of one sex rather than the other in a case where there is a particular risk that a woman will give birth to a child who will have or develop –

(a) a gender-related serious physical or mental disability,

(b) a gender-related serious illness, or

(c) any other gender-related serious medical condition.

(4) For the purposes of sub-paragraph (3), a physical or mental disability, illness or other medical condition is gender-related if the Authority is satisfied that –

(a) it affects only one sex, or

(b) it affects one sex significantly more than the other.

Licence conditions

T86 Embryos that are known to have a gene, chromosome or mitochondrion abnormality involving a significant risk that a person with the abnormality will have or develop:

a. a serious physical or mental disability

b. a serious illness, or

c. any other serious medical condition,

must not be preferred to those that are not known to have such an abnormality.

T87 Embryos that are known to be of a particular sex and are known to carry a particular risk, compared
with embryos of that sex in general, that any resulting child will have or develop:

a. a gender-related serious physical or mental disability

b. a gender-related serious illness, or

c. any other gender-related serious medical condition,

must not be preferred to those that are not known to carry such a risk.

T88 With respect to any embryo testing programme involving biopsy the centre must ensure that:


b. any information derived from tests on an embryo, or any material removed from it or from the gametes that produced it, is not used to select embryos of a particular sex for social reasons.

 

10CInterpretation of mandatory requirements

The law prohibits the selection of an embryo for treatment if it is known to:

a) have a gene, chromosome or mitochondrial abnormality involving a significant risk that the person with the abnormality will develop a serious physical or mental disability, a serious illness, or a serious medical condition, or

b) be of a sex that carries a particular risk that any resulting child will have or develop a gender-related serious physical or mental disability, serious illness, or serious medical condition

This applies only where there is at least one other embryo suitable for transfer that is not known to have the characteristics. Where there is no other embryo suitable for transfer, an embryo with these characteristics may be transferred. 

  • 10.17

    The use of an embryo known to have an abnormality as described above should be subject to consideration of the welfare of any resulting child and should normally have approval from a clinical ethics committee.

  • 10.18

    If a centre decides that it is appropriate to provide treatment services to a woman using an embryo known to have an abnormality as described above, it should document the reason for the use of that embryo.

    NOTE: An example of an embryo not suitable for transfer in this context is one that has no realistic prospect of resulting in a live birth. 

Sex selection for social reasons

10DInterpretation of mandatory requirements

The law requires that the centre should not, for social reasons:

a) select embryos of a particular sex

b) separate sperm samples, or use sperm samples that have been separated, for the purpose of sex selection, or

c) participate in any other practices designed to ensure that a resulting child will be of a particular sex.

Sex selection: sperm sorting for medical reasons

  • 10.19

    If sperm is sorted for medical reasons to create (or maximise the chance of creating) embryos of a particular sex for medical reasons, patients should be given information about the process, procedures, possible risks and the experience of the clinic in doing the procedure.

  • 10.20

    Due to concerns about the reliability of the technique, sperm that has been sorted for sex selection using gradient methods should not be used for medical reasons.

Preimplantation genetic diagnosis for histocompatibility (tissue typing)

Mandatory requirements

Human Fertilisation and Embryology (HFE) Act 1990 (as amended)

Schedule 2 – Activities that may be licensed under the 1990 Act

Licences for treatment

Embryo testing

1ZA (1) A licence … cannot authorise the testing of an embryo, except for one or more of the following purposes–

(d) in a case where a person (“the sibling”) who is the child of the persons whose gametes are used to bring about the creation of the embryo (or of either of those persons) suffers from a serious medical condition which could be treated by umbilical cord blood stem cells, bone marrow or other tissue of any resulting child, establishing whether the tissue of any resulting child would be compatible with that of the sibling

1ZA (4) In sub-paragraph (1)(d) the reference to “other tissue” of the resulting child does not include a reference to any whole organ of the child.

10EInterpretation of mandatory requirements

The law requires that the intended recipient of any donated tissue from a child born following tissue typing must:

(a) be a sibling of any child born as a result of treatment, and

(b) suffer from a serious medical condition that could be treated by umbilical cord blood stem cells, bone marrow or other tissue (excluding whole organs) of any resulting child.

The law also permits tissue typing if the embryo will not, in addition to the histocompatibility test, be tested for a particular genetic or mitochondrial abnormality.

  • 10.21

    Where preimplantation tissue typing is to be used with PGD for a heritable condition, the centre should follow the requirements and guidance applicable to a PGD service.

  • 10.22

    When deciding whether to use preimplantation tissue typing, the centre should consider the circumstances of each case individually, rather than the fact that the procedure is sought to provide tissue to treat a particular condition.

  • 10.23

    When deciding on the appropriateness of preimplantation tissue typing in a particular situation, the centre should consider the condition of the affected child, including:

    a) the degree of suffering associated with their condition

    b) the speed of degeneration in progressive disorders

    c) the extent of any intellectual impairment

    d) their prognosis, considering all treatment options available
     
    e) the availability of alternative sources of tissue for treating them, now and in the future, and

    f) the availability of effective therapy for them, now and in the future.

  • 10.24

    The centre should also consider the possible consequences for any child who may be born as a result, including:

    a) any possible risks associated with embryo biopsy

    b) the likely long-term emotional and psychological implications

    c) whether they are likely to require intrusive surgery as a result of the treatment of the affected child (and whether this is likely to be repeated), and

    d) any complications or predispositions associated with the tissue type to be selected.

  • 10.25

    The centre should also consider the family circumstances of the people seeking treatment, including:

    a) their previous reproductive experience

    b) their views and the affected child’s views of the condition

    c) the likelihood of a successful outcome, taking into account:

    i) their reproductive circumstances (ie, the number of embryos likely to be available for testing in each treatment cycle, the number likely to be suitable for transfer, whether carrier embryos may be transferred, and the likely number of cycles)

    ii) the likely outcome of treatment for the affected child

    d) the consequences of an unsuccessful outcome

    e) the demands of IVF/preimplantation testing treatment on them while caring for an affected child, and

    f) the extent of social support available.

Information for those seeking preimplantation genetic diagnosis for histocompatibility

  • 10.26

    Information given to patients considering preimplantation tissue typing should include:

    a) information about the tissue typing tests to be done

    b) an explanation of the latest evidence about any risk associated with the biopsy procedure for any child who may be born

    c) the overall likelihood of a successful outcome for the affected child, including:

    i)  the likelihood of an embryo with appropriate tissue type being available for transfer following the IVF, biopsy and genetic testing

    ii) the likelihood of a child being born as a result, taking into account the circumstances of the people seeking treatment and their previous reproductive experience

    iii) the likelihood of tissue from that child providing a successful treatment

    iv) the limitations of the treatment for the affected child

    d) the likely impact of the proposed procedure on all family members involved, and

    e) information about other sources of treatment, counselling and social support available.

  • 10.27

    If information about the disorder affecting the existing child has already been provided, for example by a regional genetics centre or by the clinical team responsible for that child’s care, it will not be necessary to provide this information again. However, the centre should:

    a) ensure that this information is satisfactorily broad and clear, and

    b) obtain a statement to that effect from those providing it.

Follow-up arrangements for preimplantation tissue typing

  • 10.28

    Centres offering preimplantation tissue typing should be able to demonstrate that they have arrangements for inviting patients and their families to take part in long-term follow-up studies. These should include long-term medical and psychosocial follow-up studies of children born as a result. Centres should strongly encourage patients and their families to participate in such studies.

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Code of Practice edition: 8