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The UK Parliament Must Act to Protect 'the Welfare of Women' in IVF

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The Human Fertilisation and Embryology Act should be reviewed to protect the "welfare of women" along with the "welfare of children". The use of gametes and embryos in IVF treatment is regulated by the Human Fertilisation and Embryology Act, enforced by the Human Fertilisation and Embryology Authority (HFEA) as an independent regulator. The focus of the HFEA has very much been on the welfare of children born though IVF and its pronouncements on the acceptability of new treatments (such as its recent reports on mitochondrial transfer) are well known and attract widespread media coverage. However, I believe the HFEA has failed to appreciate how its current approach to the publication of data regarding the performance of the clinics it regulates is detrimental to the welfare of women undergoing IVF - and indeed the welfare of the children.
So what's wrong and why now?

The HFEA publishes certain statistics for each UK IVF clinic it licences. These figures are based on the success rates per treatment cycle for each clinic. Whilst this data is intended to inform the public about each clinic's performance, it in fact creates a perverse incentive for clinics to ignore the most modern practices to avoid a serious health risk to women called Ovarian Hyperstimulation Syndrome (OHSS).

It is now known that we can eradicate OHSS using an agonist trigger and by using vitrification to freeze all embryos following egg collection in cycles where the oestrogens are high and then implanting them in a subsequent natural cycle. A recent study has shown that women who have more than 15 eggs collected per cycle have a significantly increased risk of developing OHSS. The HFEA currently counts cycles with "elective freezing to reduce OHSS" as a "failure" for the purposes of their published data, and this therefore lowers a clinic's overall success rate per cycle. This approach to publication therefore creates a situation whereby many clinics' performance appears to be inferior if they adopt the most modern practices for the safety of women undergoing IVF and their babies. Publishing IVF success per cycle incentivises clinics to put back embryo/s in cycles where women are at high risk of developing severe OHSS, thus exposing them to a potentially fatal condition.

For example, the information from the HFEA's own database tells a story. Between 2008 and 2013, 18,134 women in the UK had more than 20 eggs, 2285 women had more than 30 eggs and 313 women had more than 40 eggs collected per cycle as a result of a high response to drugs. This number is not falling, and such numbers of eggs collected are associated with a high incidence of OHSS. Notwithstanding this, only around 1000 cases of OHSS are recorded on the HFEA database because reporting of this condition is voluntary and therefore the data is unreliable.

Furthermore, evidence has also been presented to show that singleton babies born from cycles where more than 15 eggs were collected are at a significantly higher risk of being premature and of low birth weight. Yet, the HFEA's own data shows that 69,784 women who had more than 15 eggs collected per cycle had a fresh embryo transfer in the same cycle in the last 10 years.
Finally, it is also of great concern to me that no-one appears to be monitoring the drugs given to women during IVF treatment. Extremely high doses of stimulation drugs and intravenous immune therapy injections are administered to women by some clinics with no scientific evidence to support those practices. The HFEA do not collect information about drugs and dosages given to women, but we need this information to study any adverse effects of the drugs on women and their children in the future.

A Call to Action

There are three major changes that would end this situation. The first requires Parliament's intervention and will create a paradigm shift in emphasising the protection of women going through fertility treatment. We need:

1. The Human Fertilisation and Embryology Act to be updated to include the "Welfare of Women" undergoing IVF, as well as the Welfare of Children born from the procedure;
2. The HFEA should collect detailed information on drugs and dosages used in treating each woman; and
3. The HFEA should stop publishing success rate per cycle data in its current form: instead it should publish "Term Live Birth rate per Embryo Transferred" along with "Adverse Health Outcomes for women and children", including data on low birth weight and prematurity per clinic.

It is only by making these changes that the quality of care and long-term safety of IVF patients and their babies will be protected, and it will give a balanced picture about IVF outcomes to the public. The HFEA is currently conducting a consultation process and these changes must be made. It is now a matter of urgency.

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