Regulator updates rating system to warn of unproven fertility treatments

The HFEA has updated its ratings system for fertility treatment add-ons (PA)
The HFEA has updated its ratings system for fertility treatment add-ons (PA) The HFEA has updated its ratings system for fertility treatment add-ons (PA)

Fertility “add-ons” are to be graded in a new system to highlight unproven or unsafe treatments to unsuspecting patients.

Hopeful parents are often offered optional extras to their treatment which claim to improve their chances of having a baby.

Many will spend thousands of pounds on these supplementary treatments but the fertility regulator has raised concerns about clinics “unnecessarily offering unproven treatments to patients”.

As a result, the Human Fertility and Embryology Authority (HFEA) has enhanced its system which highlights the safety and efficacy of these additional treatments.

The fertility regulator is moving to a ratings system which includes five colours and symbols, including:

– Green with a plus sign suggests the treatment is effective.

– Yellow with a plus-minus symbol – it is not clear whether the add-on is effective due to conflicting evidence.

– Grey with a question mark means the HFEA cannot rate the effectiveness due to insufficient evidence.

– Black with a zero in the middle suggests that the add-on has no effect on fertility treatments.

– Red with an exclamation mark means that there are potential safety concerns over the add-on and the treatment may even hamper a couple’s chances of getting pregnant.

The HFEA’s updated fertility treatment add-on rating system has five colours that indicate whether the regulator considers the treatment effective and safe (HFEA/PA)

The HFEA said that add-ons without strong evidence of their safety and/or effectiveness should only be offered in a research setting.

And patients should not be charged extra to take part in research, it added.

“The HFEA has raised concerns for many years about some clinics unnecessarily offering unproven treatments to patients,” said HFEA Scientific and Clinical Advances Advisory Committee chairman Professor Tim Child.

“For defined patient groups, 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 treatment could be more effective.

“We have developed these ratings looking at all the evidence available and with input from clinicians, embryologists, scientists and patients. We strongly encourage patients to look at and use this information when talking to their clinics.”

HFEA chief executive Peter Thompson added: “People going through treatment are often spending a lot of money and want to have a baby as soon as possible and do everything they can to improve the chances of success.

“But when some add-ons cost hundreds or even thousands of pounds each, we want to make sure patients have the best available information.

“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 system.”

Fertility add-on treatments can include genetic tests, drugs, surgery and equipment.

An example of a red category add-on is endometrial receptivity testing, which purports to find the optimal time for an embryo to be transferred into a woman’s womb.

Embryo glue (also known as hyaluronate enriched pre-transfer culture medium), which claims to help the embryo implant in the womb, has been rated as yellow – meaning it is not clear whether it is effective at improving chances of pregnancy.

The HFEA said it cannot rate the effectiveness of embryo “hatching” treatments or intrauterine cultures due to insufficient evidence, and both have been rated grey.

Commenting on the new system, Dr Catherine Hill, head of policy and public affairs at Fertility Network UK, said: “Because of the lack of access to NHS-funded fertility treatment in the UK, the majority of fertility patients have to make decisions about the type and amount of fertility care they purchase.

“These emotionally and financially difficult decisions often centre on whether to try expensive fertility treatment add-ons and are typically made when patients are at their most vulnerable – desperate to try anything if there is a chance it may help them become parents.

“Fertility Network is aware of how stressful and confusing purchasing private fertility treatment can be for patients, and we welcome this updated treatment add-on ratings system and encourage fertility patients considering a treatment add-on to look at the enhanced information on the HFEA website before making any decisions.”