Multiple births

Refer to principles 5, 6, 7, 10 and 13

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;
6.
ensure that patients and donors have provided all relevant consents, before any licensed activity is undertaken;
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;
10.
maintain proper and accurate records and information about all licensed activities;
13.
conduct all licensed activities with proper regard for the regulatory framework governing treatment and research involving gametes or embryos within the UK. including:
- maintaining up to date awareness and understanding of legal obligations;
- responding promptly to requests for information and documents from HFEA; and
- co-operating fully with inspections and investigations by HFEA or other agencies responsible for law enforcement or regulation of healthcare.

…see all the principles

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Mandatory requirements

Licence conditions

T123
The centre must not exceed the maximum multiple birth rate specified by Directions.

Directions

0003 - Multiple births

HFEA guidance

Strategy to minimise multiple births

7AInterpretation of mandatory requirements

HFEA Directions require centres to have a documented strategy to minimise multiple births. Its purpose is to reduce the annual rate of multiple births resulting from treatments at the centre.

The strategy must set out:

a) how the centre aims to reduce the annual multiple birth rate following treatment at that centre, and to ensure the rate does not exceed the maximum rate specified by the Authority as set out in Directions,

b) the circumstances in which the person responsible would consider it appropriate to recommend single embryo transfer (SET) to a patient (in setting out such circumstances, the centre should give proper consideration to relevant professional guidance), and

c) the criteria for transferring eggs during gamete intrafallopian transfer (GIFT).

The centre must document regular audits that:

a) assess progress in reducing its multiple birth rate, and

b) help evaluate the effectiveness of its strategy.

If more than one embryo is transferred to a patient who fulfilled the SET criteria outlined in the centre’s strategy, this should be recorded in the patient’s medical records, with:

a) an explanation of why the patient did not have SET, and

b) evidence that the risks of a multiple pregnancy were fully discussed with the patient before the procedure.

The centre must keep a summary log of all cases where more than one embryo was transferred to a patient who met the SET criteria outlined in the centre’s strategy.

Limits on egg and embryo transfer

7BInterpretation of mandatory requirements

HFEA Directions require centres to:

a) detail in patients’ medical records each time during a treatment cycle that four eggs or three embryos are placed in a woman, including the reasons, and

b) keep a summary log of every treatment cycle that involves the placing in a woman of four eggs or three embryos.

7.1
The person responsible should ensure that the centre's annual multiple birth rate does not exceed the figure specified by Directions..
7.2
When implementing the centre’s strategy to minimise multiple births, the person responsible should consider the higher rate of multiple births from blastocyst transfers.
7.3
Where appropriate, the centre should have documented standard operating procedures for egg and embryo transfer.
7.4
The centre should not transfer more than three eggs or two embryos in any treatment cycle if:

a) the woman is to receive treatment using her own eggs, or embryos created using her own eggs (fresh or cryopreserved), and

b) the woman is aged under 40 at the time of transfer.
7.5
The centre should not transfer more than four eggs or three embryos in any treatment cycle if:

a) the woman is to receive treatment using her own eggs, or embryos created using her own eggs (fresh or cryopreserved), and

b) the woman is aged 40 or over at the time of transfer
7.6
If a woman is to receive treatment using donated eggs or embryos, or embryos created with donated eggs, the centre should not transfer more than three eggs or two embryos in a treatment cycle. This is regardless of the procedure used and the woman’s age at the time of transfer.

Consent and provision of information

7.7
If the treatment involves the use of superovulatory drugs or the transfer of multiple eggs or embryos in any one cycle (whether fresh or previously cryopreserved), the centre should give people seeking treatment information about the risks of multiple pregnancy for the woman, the fetus and any resulting child(ren), including the:

a) the higher risk of miscarriage and complications during pregnancy

b) the higher rate of premature birth and the problems arising from low birth weight, the higher rate of still birth, and the higher rate of perinatal mortality

c) the higher rate of disability and other health problems, plus the potential need for extended stays in hospital before and after birth, and

d) the possible practical, financial and emotional impact on the family and any children.
7.8
The centre should give the woman the opportunity to discuss the number of eggs or embryos to be transferred before egg collection and just before embryo transfer.
7.9
If a woman is to undergo an egg or embryo transfer, the centre should:

a) obtain her consent to the proposed number of eggs or embryos to be transferred and the reasons for this (including her acceptance of the risk of multiple births), and

b) record her consent in her medical records.

Other legislation, professional guidelines and information

Elective Single Embryo Transfer: Guidelines for Practice, British Fertility Society and Association of Clinical Embryologists, Human Fertility, Volume 11, Issue 3 September 2008 , pages 131–146
One at a time – better outcomes for fertility treatment (a web-resource for professionals and the public aimed at reducing the rate of multiple births).

Code of Practice version: 8

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