The Human Fertilisation and Embryology Authority (HFEA) has published a final consensus statement advising that IVF clinics should not charge patients for add-on treatments that are not proven effective by clinical trials (see comment).
The HFEA is the UK's fertility regulator, and the statement was issued jointly with 10 other professional bodies including the British Fertility Society, Royal College of Obstetricians and Gynaecology and the European Society of Human Reproduction and Embryology.
'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,' Jason Kasraie, chair of the Association of Clinical Embryologists and a signatory to the consensus, told the Telegraph.
The HFEA has pioneered a traffic light rating system to help patients identify if a particular add-on is safe and effective. A red designation indicates there is no evidence the add-on is safe and effective while an amber designation suggests further research of the treatment is required before it is proven safe and beneficial for use.
None of the top ten most popular add-ons has yet been rated green (more than one good quality randomised controlled trial which shows that the procedure is effective and safe).
The report expresses concern that IVF clinics feel obliged to offer add-ons, because patients will go elsewhere if they are not available, even though there may be no evidence of their effectiveness and safety in clinical studies. The consensus statement says that where treatments are not proven to be beneficial, they should only be offered to patients as part of clinical trials with proper ethical oversight. Patients should not be charged extra to take part in research.
The statement also sets seven principles of responsible innovation as guidance to professionals in the UK to ensure greater transparency is given to patients about add-on treatments. Patients must have the ability to make a fully informed decision after reviewing the effectiveness and safety of experimental treatments.
Sally Cheshire, chair of the HFEA, said: '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.'