IVF - managing the risks

Currently, 25% of in vitro fertilisation (IVF) and intra-cytoplasmic sperm injection (ICSI) pregnancies in the UK leads to the birth of twins. This is around 20 times the risk expected after natural conception.

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On this page

• What is the official guidance? 
• HFEA policy decision
• NICE guidelines 
• What is the view of the Department of Health? 
• Minimising the risks
  

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What is the official guidance?

The current HFEA guidelines state that:

Where a woman is to receive treatment using her own eggs, or embryos created using her own eggs, whether fresh or previously cryopreserved: 

1. where the woman is aged under 40 at the time of transfer the centre should not transfer more than 2 eggs or 2 embryos in any treatment cycle, regardless of the procedure used; 
2. where the woman is aged 40 or over at the time of transfer the centre should not transfer more than 3 eggs or 3 embryos in any treatment cycle, regardless of the procedure used.
   
   

HFEA policy decision

However, despite the limits of no more than 2 embryos (or 3 for women over 40) to be transferred, the twin rate is still too high at 25% for in vitro fertilisation (IVF) and intra-cytoplasmic sperm injection (ICSI) pregnancies.

In its recent review, the HFEA decided that the Year 1 interim target for implementing the multiple births policy will be 24% IVF/ICSI multiples (the current national average).    

This target will be a maximum ´upper limit´ that all clinics will be expected to meet, and be introduced as of 1st January 2009. Over the next 2–3 years, the HFEA will set progressively lower interim targets during the implementation phase, towards the final goal of a 10% national rate.
 
The HFEA also agreed that all clinics will also need to produce a ´multiple births minimisation´ strategy, which will include an outline of how they plan to reach the HFEA-set target. This will also be introduced at the same time as the Year 1 target.
 
The HFEA based its decision about the Year 1 target on assessments of: 

• Its feasibility
• The impact it will have on multiple birth rates
• The extent to which the target might affect pregnancy rates, on a per transfer basis.

Following this impact analysis, the HFEA was confident that the Year 1 target would have only a minimal impact on pregnancies rates. However, it will closely monitor the impact of targets on pregnancy rates during the course of the 3 year implementation phase.

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NICE guidelines

The NICE Guidelines  on IVF and multiple pregnancy state that:  

• Couples should be informed that the chance of multiple pregnancy following in vitro fertilisation treatment depends on the number of embryos transferred per cycle of treatment. To balance the chance of a live birth and the risk of multiple pregnancy and its consequences, no more than two embryos should be transferred during any one cycle of in vitro fertilisation treatment. This recommendation is a key priority for implementation. (para 1.10.3.1)
• Couples in which the woman is aged 23–39 years at the time of treatment and who have an identified cause for their fertility problems (such as azoospermia or bilateral tubal occlusion) or who have infertility of at least 3 years´ duration should be offered up to three stimulated cycles of in vitro fertilisation treatment. This recommendation is a key priority for implementation. (para 1.10.8.1) 
• Embryos not transferred during a stimulated in vitro fertilisation treatment cycle may be suitable for freezing. If two or more embryos are frozen then they should be transferred before the next stimulated treatment cycle because this will minimize ovulation induction and egg collection, both of which carry risks for the woman and use more resources. This recommendation is a key priority for implementation. (para 1.10. 8.2)

See the NICE website for more information.

What is the view of the Department of Health?

At the time the NICE Guideline was published in February 2004, the then Secretary of State for Health, Mr John Reid MP, issued a statement on the same subject. He said that all Primary Care Trusts (PCTs) in England were expected to provide 1 full cycle of treatment to all those fulfilling the criteria by April 2005.

The NICE guideline defines a full cycle as including the freezing and replacement of suitable embryos not transferred during a stimulated IVF cycle. John Reid also said that he expected PCTs to implement the full guideline (that is, 3 full cycles) in the longer term.

In a letter from Dawn Primarolo MP (Minister of State for Public Health) in July 2007 to PCTs, the Department of Health restated the NICE recommendation on what constitutes a full cycle. The letter also said "The department is looking to PCTs to move towards the provision of 3 full cycles of IVF, for those who need it, as recommended in the NICE guideline."

Minimising the risks

To balance the risks of multiple pregnancy with the chance of a positive outcome, the following approach is recommended:

• The British Fertility Society (BFS) and the Association of Clinical Embryologists (ACE) have recently issued professional guidelines on elective single embryo transfer (eSET). These guidelines can be found on the website of the journal, Human Fertility.  Further information about these guidelines will appear on this website soon.
• Each fertility centre/clinic should have a protocol in place for eSET and all staff should be aware of and follow the correct procedure.
• It is important to explain to patients the risks of multiple pregnancy associated with IVF and to give details of the types of problems that accompany multiple pregnancies and births. For more information see What are the risks?
• Follow up with written information (brochures, leaflets, etc).
• In particular, the effect that multiple embryo transfer has on the risk of multiple pregnancies should be fully explained and the option of choosing single embryo transfer (eSET) should be discussed, if appropriate for the individual patient. For more information see Which patients are suitable for SET?
• If eSET is offered and the initial treatment with a fresh embryo is unsuccessful, it is important to offer follow-up treatment consisting of freezing and storage of viable embryos, and further single embryo transfer.

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