Fertility regulator calls for clinics to be more open about treatment add-ons

The Human Fertilisation and Embryology Authority (HFEA) and 10 of the leading professional and patient fertility groups, have agreed how treatment add-ons should be offered ethically in clinical practice in the UK in a consensus statement published today.

It’s published in response to growing evidence of add-ons being offered to patients, without conclusive evidence to date that any of them increase the chance of a pregnancy, and the fact that many patients feel they must do anything to improve the possibility of success. The aim is to create a culture change among fertility professionals in the UK.

Sally Cheshire CBE, Chair of the HFEA, said:

“We welcome the introduction of new treatments that could increase the chances of success, however, we want to see responsible innovation. Fertility treatment add-ons are being offered to more patients by clinics and we know many patients are asking for these add-ons and paying for them if they have private treatment.”

“It’s crucial that clinics are transparent about the add-on treatments they offer, including the potential costs, to ensure patients know exactly whether they are likely to increase their chance of having a baby.

“That is why we’ve been working with professional groups such as the British Fertility Society to decide how unproven treatments into clinical practice should be correctly and ethically introduced, which is a vital step towards a more transparent approach in fertility services.

“We are now expecting clinics to provide information about treatment add-ons to patients, including what evidence there is of effectiveness.”

Alongside the principles for clinics, the HFEA has also published information on the most commonly offered add-ons, with a traffic light rating system, to help patients better understand the effectiveness of treatments they might consider.

Sally adds: “It’s crucial that patients inform themselves about the add-ons they may be offered, so that they can ask the right questions, and make the right choices, when choosing what treatment to have. We’ve produced ‘traffic light’ rated information on our website that keeps them up-to-date with the latest evidence on each of the most commonly offered add-ons.”

Jason Kasraie, Chair of the Association of Clinical Embryologists, said:

“We support greater transparency in the sector with regard to treatment add-ons. Whilst it is important that we work to ensure patients always receive the latest treatments and have access to new technologies in order to maximise their chance of treatment success, it is also essential that we ensure patients are fully informed and that only procedures or technologies that are evidence based are used.”

Key principles of the consensus statement are:

• Clinics should only offer treatment add-ons where more than one high quality study demonstrates a treatment add-on to be safe and effective.
• Clinics should stop offering the treatment add-on to patients if concerns are raised regarding safety or effectiveness.
• Patients must be clearly informed of the experimental nature of any treatment add-on which is offered, where there is no robust evidence of its safety and/or effectiveness
• Patients should not be charged extra to take part in a clinical trial.

The General Medical Council, has welcomed the statement. Chief Executive, Charlie Massey said:

"We welcome this consensus statement, which will help protect fertility patients from poor practice and feeling pressure to accept additional, unproven extras. Patients deserve to have the best available evidence so they can make informed decisions, in partnership with doctors.

"It’s vital that doctors innovate responsibly and place patient safety first and foremost. Our guidance on consent sets out how doctors should work with patients to make decisions together about care and treatment options. Doctors working in the fertility sector must ensure that patients have information about the options available to them, including risks and available evidence, as well as any potential benefits."

ENDS

For further information, including interview requests, please contact Ramona Aning, External Communications Manager, T: 020 7291 8302, E: ramona.aning@hfea.gov.uk

Notes to editors

Download the consensus statement (PDF 460 KB)

The HFEA add-on treatments information is available at www.hfea.gov.uk/treatments/explore-all-treatments/treatment-add-ons/

According to the latest HFEA’s national fertility patient survey:

• For those that had treatment in the last two years, three quarters (74%) had at least one type of treatment add-on, similar to 71% of those in the past five years. 
• The most commonly used treatment add-ons for those that used a fertility clinic in the past two years were clinical techniques, such as an endometrial scratch (27%), embryo glue (23%) or embryoscope (22%).

Signatories of the consensus statement include:

• Association of Biomedical Andrologists
• Association of Clinical Embryologists
• British Andrology Society
• British Fertility Society
• British Infertility Counselling Association
• European Society of Human Reproduction and Embryology
• Fertility Network UK
• Human Fertilisation and Embryology Authority
• Royal College of Nursing
• Royal College of Obstetricians and Gynaecologists
• Senior Infertility Nurses Group