Training workshops 2010

• HFEA clinic workshops on multiple births
• Multiple births policy – Year 1 evaluation
• What was learnt?
  • Patient selection and clinical issues
  • Patient engagement
  • Patient choice
  • Variable NHS commissioning policies
  • Sector strategy
  • HFEA regulation

HFEA clinic workshops on multiple births

In early 2010 the Human Fertilisation and Embryology Authority (HFEA) held a series of workshops for clinic staff across the UK.

The workshops were designed to update clinics about the revised multiple births policy. Bringing staff together from different clinics, the workshops also gave clinicians the opportunity to share successes and issues and to discuss emerging best practice.

The HFEA is the UK regulator overseeing the use of gametes and embryos in fertility treatment and research.

• Read more about the multiple births policy
• Visit the HFEA website 

Multiple births policy – Year 1 evaluation

At the workshops, the HFEA gave an update on the first year of the multiple births policy – a policy designed to lower the rate of multiple births following fertility treatment.

An initial analysis of the national data collected by the HFEA from clinics for fresh treatment cycles shows that:

• there has been an increase in elective single embryo transfers (eSET) in 2009, with the greatest increase in women under 35
• there has been an increase in blastocyst transfers in 2009
• there has been a slight decrease in the overall multiple pregnancy rate in 2009
  - the biggest decrease has been in women under 35
  - there has only been a slight decrease in women aged 35 – 37 and a slight increase in women aged 37 – 39
• the multiple pregnancy rate from double blastocyst transfers is extremely high. This may be driving up the multiple pregnancy rates in slightly older women
• the difference in overall pregnancy rates for eSET compared to two embryo transfers is marginal (though currently eSET patients are more likely to become pregnant)
• that approximately two-thirds of clinics are predicted to meet the year 1 maximum multiple birth rate of 24%.

It’s encouraging that the proportion of eSETs is rising and that this increase appears to have resulted in a lower multiple pregnancy rate in 2009 compared to 2008, especially for women under 35.

Importantly, the current effect on overall pregnancy rates appears minimal.

• Data slides of the national data

What was learnt?

Speakers from different clinics talked about their experience of implementing their multiple births minimisation strategies and how they graded, assessed and froze embryos.

During the lively discussions a number of key issues and lessons were identified:


Patient selection and clinical issues

• Embryo quality appears more important than age as even older women with good embryos or blastocysts are at risk of a multiple birth
• It is not good practice to transfer two good quality blastocysts, especially to younger women, as the multiple pregnancy rate is extremely high
• Patients eligible for eSET must feel that this is their best clinical option, with a subsequent frozen embryo transfer if needed
• eSET is not considered appropriate for patients who have had successive failures
• Clinics need to carry out regular audits of their data to see where their multiple births are coming from
• Training staff on embryo assessment at day 4 and day 5 is crucial for effective use of blastocyst culture
• Clinics reported increasing use of vitrification but advised it can take up to six-months for embryologists to become competent at this method.

Participants discussed embryo grading and freezing protocols in their clinics. Both embryo transfer at cleavage stage and blastocyst transfers had their supporters.

Specific suggestions included:

• adapting the ACE/BFS eSET guidelines for cleavage stage embryos - using a scoring range of day 2: 4 (4/3)/(4/3) and day 3: 6-8 (4/3)/(4/3)
• for blastocysts, embryos scoring 3-6 Aa/Ab/Ba/Bb was seen as an effective approach
• with frozen day 3 embryos, depending on availability, thaw out three or four, culture to blastocyst and preferably put back one (depending on quality)
• consider freezing suitable embryos at cleavage stage and day 5 blastocysts
• if using vitrification, thaw one blastocyst and transfer one at a time.

Read the British Fertility Society (BFS) / Association of Clinical Embryologists (ACE) eSET guidelines

Patient engagement

• All clinic staff need to be onboard with the clinic’s eSET policy.
• Patients need to trust clinic staff – those that qualify for eSET should be made to feel that clinically this is the best option for them.
• Clinics that have good patient uptake of eSET give information early on and throughout treatment, provide consistent, positive advice from all staff members and use their own data to support the benefits and efficacy of eSET.

Patient choice

• Should clinicians allow patients, especially self-funded patients, to decide the number of embryos to put back even if clinically, they are suitable for SET?
• Satient choice needs to be understood in the context of safe, good practice and the individual clinic’s professional judgement and responsibility.

Variable NHS commissioning policies
A number of clinics commented that many Primary Care Trusts (PCTs) and health boards:

• have different interpretations of cycles and this impacts how they fund treatment
• still sometimes impose a one size fits all approach based on age for the number of embryos permitted for transfer which fails to recognise differences in embryo quality
• do not include frozen embryo transfer (FET) in their funding arrangements which mitigates against an effective SET approach.

Sector strategy

• Should clinics in other parts of the UK operate a common SET policy just like clinics in the West Midlands successfully do?
• All clinics in the West Midlands region worked together to set the same patient selection criteria for SET across their clinics.  Any patient at a West Midlands clinic who qualifies for SET will only receive treatment on that basis. Patients will not be able to go to another clinic in the region to have two embryos transferred. West Midland clinics have been particularly successful in reducing their multiple rates without compromising their overall success rates.
• At the Birmingham workshop, staff said that one of the advantages of this approach is that patients suitable for SET feel very positive about their treatment because they know their prognosis is good, don’t agonise over a ‘choice’ or feel guilty about not putting two back if their first attempt is unsuccessful.

HFEA regulation

• Workshop participants felt the first year was about clinics introducing new approaches and processes, and gaining confidence. The 2nd year will be crucial to the success of the policy. #
• Many clinic staff were keen to know more about how the Authority will regulate clinics that are not making an effort to comply with the policy.
• The HFEA emphasised their commitment to ensuring proportionate and consistent enforcement of the policy.  The Authority is currently analysing individual clinics’ performance in Year 1 of the policy and will be reporting back to centres at the end of Summer 2010. Centres who have not demonstrated any change in practice will be asked to attend a management review meeting.
• There was wide support for HFEA removing its fee for frozen embryo transfers (FET) following an initial SET.