HFEA committed to improving clarity around fertility treatment add-ons 

In vitro fertilisation (IVF) and intrauterine insemination (IUI) are established treatments that have been proven effective for most patients.

Treatment add-ons are optional non-essential treatments that may be offered in addition to such proven fertility treatment. They exist in clinical practice with the aim of improving the outcomes of fertility treatment, most commonly, they claim to improve the chances of having a baby, but add-ons may also be offered for other reasons. They may be offered, for example, where there is evidence that a treatment add-on could reduce the risk of a patient developing ovarian hyperstimulation syndrome (OHSS). In some circumstances, therefore, there may be a justifiable medical reason for using an add-on.

Offered responsibly, they can be a sign of healthy innovation in the fertility sector. However, the evidence to support the use of add-ons for most fertility patients is usually missing, limited or not very reliable.

Improved information for patients

The Human Fertilisation and Embryology Authority (HFEA) has raised concerns for many years about some clinics unnecessarily offering unproven treatments to patients. Since information about add-ons is increasingly available online, discussed in the media and in online discussion groups, many patients have strong views about the apparent advantages of a particular treatment add-on before they step into the clinic. For defined patient groups, for example, patients who are at most risk of OHSS, there are particular treatment add-ons that may be potentially beneficial, but we know that for the vast majority of patients, more rounds of proven IVF treatment without using any treatment add-ons could be more effective.

One example of this would be elective freeze all cycles, which involve creating embryos using IVF or ICSI and then choosing to freeze them all so no embryos are transferred in a 'fresh' cycle. The embryos are thawed a few months later and transferred to the patient's uterus as part of a frozen embryo transfer cycle. While this add-on is rated amber as it is not clear whether it is effective at improving the changes of having a baby, it has been proven to be effective at reducing the risk of developing OHSS in patients with an increased risk – and it is rated green for that particular patient group.

Patients undergoing fertility treatment now have better information on whether 'add-on' treatments will improve their chances of having a baby as well as other outcomes, as the HFEA launches its new ratings (see BioNews 1212).

The improved rating system now has five-categories giving more detailed information for patients than previously, which will help patients make better-informed decisions about their treatment. We have developed these ratings looking at all the evidence available and with input from clinicians, embryologists, scientists and patients. As well as assessing the evidence as to whether a particular add-on increases the chance of a live birth, the new ratings also show outcomes such as miscarriage rates or whether a particular patient group would benefit from each add-on.

In line with the HFEA Code of Practice, clinics must give patients a clear idea of what any treatment add-on will involve, how likely it is to increase their chance of a successful pregnancy and how much it will cost, and link to the HFEA ratings.

We hope that the improved information will empower patients to ask relevant questions about the use of add-ons and their treatment when talking to their clinics, so they make an informed decision based on what’s right for them.

The responsible use of treatment add-ons in fertility services: a consensus statement

As well as the new ratings, the HFEA and eight professional and patient bodies have reaffirmed their commitment to the responsible use of treatment add-ons in an updated consensus statement. We in the fertility sector in the UK are concerned that many patients are being frequently offered, and charged for, optional extras to their treatment which claim to improve their chances of having a baby. This consensus statement sets out that add-ons without strong evidence of their safety and/or effectiveness should only be offered in a research setting. The consensus statement also makes it clear that patients should not be charged more to take part in research, including clinical trials. This updated statement reflects the signatories ongoing commitment to monitor the evidence base for treatment add-ons and their offering in UK clinics.

We want to continue to move towards a more consistent and transparent approach to the use of treatment add-ons in fertility services.

*Set up in 1991, the HFEA is the independent regulator of fertility treatment and human embryo research in the UK. Information is key when thinking about or going through fertility treatment. The HFEA supports patients by providing free, clear, and impartial information about fertility treatment, clinics and egg, sperm and embryo donation. Find out more at www.hfea.gov.uk