Regulation and its impact on clinical practice

In the UK 40% of all IVF babies are twins, and this is thought to be the main reason behind the increasing number of babies born as multiples, rising from 11941 in 1978 to 18,395 in 2003 (Office of National Statistics). There are significantly greater risks for both mother and babies with a twin pregnancy. In December 2007 the Human Fertilisation and Embryo Authority (HFEA) announced their intention to introduce an outcome-based policy to reduce the rate of multiple pregnancies following ART to no more than 10% within three years. This figure will be reached by introducing interim targets on an annual basis, with the first target 24% from January 2009. To achieve these targets there needs to be a substantial change in clinical practice, increasing the proportion of patients where one embryo is transferred following IVF or ICSI treatment. To implement this change the Authority coordinated and funded a multidisciplinary National Strategy Multiple Births Stakeholder group with representation from all interested parties, including patient groups and professionals. Strategies to promote this initiative include a series of training workshops on single embryo transfer, a communication campaign headed by a new website Oneatatime.org. uk, and the production of professional guidelines by the BFS and ACE, published in this edition of Human Fertility (Cutting et al., 2008). These guidelines are the first of a series to be produced by the BFS and ACE working in unison. This joint guideline focuses on the effectiveness of eSET, both in terms of the impact on success rates and on the principle aim of reducing multiple births. The two most important criteria that emerge to help patient selection are the woman’s age, and the quality of embryos available. To aid appropriate embryo selection, two embryological grading systems are described, one for early cleavage stage and the other for blastocysts. The aim is to introduce uniformity into embryo selection, although further research will be required to confirm these grading systems are effective. A simple algorithm for eSET, based on embryo quality, is provided. The guideline explores a number of strategies to help individual clinics introduce their own eSET policy and does not seek to be prescriptive. The second guideline in this issue on Embryo cryopreservation (Granne et al., 2008) is complementary to the eSET document. All available evidence suggests that embryo cryopreservation is crucial to making eSET effective. The guideline comprehensively covers embryo selection pre and post cryopreservation, the optimal time for embryo cryopreservation, and the subsequent thawing and transfer procedures. It is essential to recognize that the introduction of eSET without an increase in NHS funding is likely to have an adverse impact on the live birth rates in the UK, as currently only 60% of primary care trusts (PCTs) fund embryo cryopreservation (INUK survey 2006). When eSET, is used, parity with double embryo transfer is only achieved if the frozen embryo transfer cycles are included. The alternative is that patients will have to bear the increased costs. However, there is good evidence in other health care settings where appropriate funding is available that eSET is effective in reducing multiple pregnancy, and if the costs of neonatal care are included, more cost effective than double embryo transfer (Heijnen et al., 2007). Figures from the HFEA confirm that the number of men recruited for sperm donation have fallen from 503 in 1991 to 260 in 2005, with the fall apparent before the removal of donor anonymity in 2005 (HFEA). Although the advent of intracytoplasmic sperm injection has certainly had an impact on demand, there remains a significant need for sperm donors, which is not matched by the current supply. The BFS and a multidisciplinary working party report, published in this issue (Human Fertility 2008) estimate that approximately 4000 patients per annum require donor sperm. The working party proposes setting up a nationally coordinated approach to sperm donation services using a Hub and Spoke arrangement. The proposal involves setting up 14 regional centres (hubs), which would provide the bulk of donor management, with both the regional Human Fertility, September 2008; 11(3): 129–130