The NICE Guideline
In 2004 NICE produced a clinical guideline entitled Fertility: assessment and treatment for people with fertility problems, which made a number of recommendations for the provision of IVF.
The 2004 guideline recommended that 3 cycles of IVF treatment should be provided to infertile couples who had an identified cause for their fertility problems or who had infertility of 3 years duration. In addition to this the guideline recommended that the age ranges of the woman in receipt of the treatment should be between 23-39.
Recognising the advancements in clinical practice, NICE began updating this guideline in 2012 – the final revised guideline was published in February 2013.
The new guideline included the following key recommendations:
- 3 full cycles of IVF/ICSI should be provided where the female partner is aged 39 and under. A full cycle of IVF/ICSI has been clearly defined as one in which 1 or 2 embryos are replaced into the womb as fresh embryos (where possible) with any remaining good-quality embryos frozen for use later. When these frozen embryos are used, this is still considered to be part of the same cycle.
- IVF treatment should be made available to women who have been unable to conceive after two years of regular vaginal intercourse (or 12 cycles of artificial insemination). This is one year less than was previously recommended.
- Women aged 40-42 years who have not conceived after two years of regular unprotected intercourse or 12 cycles of artificial insemination (where six or more are by intrauterine insemination), should now be offered one full cycle of IVF, with or without ICSI, provided the following criteria are fulfilled: they have never previously had IVF treatment; there is no evidence of low ovarian reserve; there has been a discussion of the additional implications of IVF and pregnancy at this age. Previously, NICE did not recommend IVF for women older than 39.
- Unstimulated intrauterine insemination should be considered as a treatment option for :
- People who are unable to, or would find it very difficult to, have vaginal intercourse because of a clinically diagnosed physical disability or psychosexual problem using partner or donor sperm.
- People with conditions that require specific consideration in relation to methods of conception (for example, after sperm washing where the man is HIV positive)
- People in same-sex relationships
The importance of providing up to three full cycles
NICE’s retention of the three cycle recommendation should send a clear signal to commissioners as to the level of service patients should receive.
It remains the case that in order to optimise cost effectiveness, people should receive three full cycles of IVF. Each full cycle, as defined by NICE should include the initial fresh cycle, followed by frozen cycles – depending on the number of embryos produced. At the end of this, if conception has not occurred, they would start another fresh cycle followed by frozen cycles, and so on.
The importance of providing three full cycles of IVF is underpinned by the fact that not all people yield the same amount of viable embryos for transfer. Some may only yield one. These couples are immediately placed at a disadvantage if the option of a third fresh cycle is not made available to them.
A study conducted in 2009, found that the cumulative effect of providing three full cycles of IVF increased the chances of a successful pregnancy to 45-53%. Given the upward trend in success rates, this percentage is likely to only increase over time.
The risk of multiple pregnancy
Multiple pregnancy is recognised as the most common complication presenting the greatest risk for mothers and babies. In January 2009, following an expert group report and public consultation, the HFEA introduced a policy for elective single embryo transfer (eSET) in order to minimise the risk of multiple pregnancies with the overall aim of reducing the UK IVF multiple birth rate to 10%.
The introduction of elective single embryo transfer (eSET) for women most likely to have a multiple pregnancy has increased the importance of offering three full cycles of IVF. Data has confirmed that success rates are not significantly reduced and multiple pregnancies minimised where this approach is adopted.
The emphasis on eSET in the latest NICE guideline (2013) is a welcome development and should help reduce costs to the NHS (a multiple pregnancy is estimated to cost the NHS an average of £4000 more than a singleton pregnancy).