The Human Fertilisation and Embryology Authority Treatment has today called for a change in the way optional fertility treatment extras are offered to patients and outlined key guidance for health professionals when doing so.
“This document will empower nurses to contribute to changing the culture around fertility treatment add-ons”
In collaboration with 10 of the leading professional and patient fertility groups, including the RCN, the fertility regulator has drawn up a new consensus statement on the topic of add-on treatments and their use and promotion.
The document, published today, highlighted that, when offered responsibly, add-ons could be a sign of healthy innovation in the fertility treatment sector. But it noted that there was currently no conclusive evidence that any of the add-ons being offered actually increased the chance of pregnancy or birth.
Therefore, the document has set out key principles of responsible innovation to help guide health professionals in the UK when offering these services in the future.
Among the key principles, it states that clinics should only offer treatment add-ons where more than one high quality study demonstrates it to be safe and effective and that clinics should stop offering the treatment to patients if concerns regarding safety or effectiveness are raised.
“We know many patients are asking for these add-ons and paying for them if they have private treatment”
It also said 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, and that patients should not be charged extra to take part in a clinical trial.
The regulator said the consensus statement had been published in response to growing evidence that add-ons are being offered without conclusive evidence that they increased the chance of pregnancy, in addition to the fact that many patients felt they must do anything to improve the possibility of success.
Within its document, the HFEA highlighted that “practitioners have a duty of care to patients, which should separate pressure from patients and commercial interests from their best practice advice”.
It added that “culture change is required, if the potential benefits of new treatments are to be offered responsibly”.
Responding to the consensus statement, Bronagh Scott, director of nursing, policy and practice at the RCN said: “Some people who require treatment to help them to have a healthy baby can become desperate and will try a wide range of treatments, not all of which are based on sound evidence.”
Ms Scott noted that the RCN’s fertility nursing forum had been working with the HFEA and other key stakeholders to try and ensure that only “evidence-based” products and procedures were offered to those seeking fertility services.
“This includes ‘add-ons’ – optional extras to their treatment which claim to improve their chances of having a healthy baby,” she said. “It’s important that people seeking fertility treatment aren’t offered add-ons that have no conclusive evidence to suggest they’re effective or safe.”
“This document will empower nurses to contribute to changing the culture around fertility treatment add-ons and ensure any innovations in the field are responsible and ethical,” she said.
“It’s crucial that clinics are transparent about the add-on treatments they offer”
Alongside the principles for the clinics, the HFEA explained that it has also published information on the most commonly offered add-ons, including a traffic light system to help patients better understand the effectiveness of the treatments they might consider.
HFEA chair Sally Cheshire 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,” she said.
She added: “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.”
Therefore, Ms Cheshire said the HFEA had been working with professional groups, like the British Fertility Society, “to decide how unproven treatments into clinical practice should be correctly and ethically introduced”. She noted that this was 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,” she stated.
Ms Cheshire also highlighted the new traffic light system, which is available on the HFEA website, as a way of providing patients with the latest evidence on each of the most commonly offered add-ons.
She 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.”