ESHRE suggests good practice recommendations for add-ons in reproductive medicine

Innovation is a key aspect and driving force in fertility treatment which has enabled clinicians and laboratory professionals to help millions of couples with fertility issues to become parents.

Still, a considerable proportion of patients and their partners remain childless even after fertility treatment. These couples are often desperate to achieve a pregnancy, and there may be pressures on the professionals treating them to try to do so. The fact that many of these patients need to carry the costs of their own medical testing and fertility treatment means they are financially motivated to increase their chances of conception with each cycle they embark on.

Add-ons, defined in the guideline as 'tests or treatments being not clinically relevant for an IVF/ICSI cycle but optional additional procedures that are sometimes offered on top of standard fertility procedures', and most often at an additional cost for the patient, have been increasingly implemented in clinical practice. While innovation is considered beneficial, the uptake of innovative and unnecessary procedures and treatments in clinical practice without established benefit and safety, or even a rationale, is an increasing concern among experts in the field, but also to the general public.

To address this concern, a working group under the umbrella of the European Society of Human Reproduction and Embryology (ESHRE) has investigated published data for over 30 tests and treatments which are offered to patients and their partners while undergoing fertility treatment. The aim of this exercise was to document if trustworthy data supporting the benefit and safety of these add-on tests and treatments were available. The results of this effort were less encouraging as it was shown that there was evidence supporting the safe use to increase the live birth rate for just a handful of tests and treatments, and often only in a certain subgroups of patients.

While many tests and treatments offered as add-ons still warrant further research and studies to clarify their efficacy and safety, for most interventions assessed, the working group could only conclude they should not be recommended for use in clinical practice. For some of these test and treatments, it was considered there was no rational for their use, while for others there was not sufficient research carried out to draw conclusions from, or studies existed showing they did not increase pregnancy or live birth rates. A third category included interventions that could potentially have negative effects on the patients or their future children.

For all of the included tests and treatments, the group created a statement on whether or not they should be routinely offered to patients, based on current evidence for safety and efficacy, or only offered to certain patient groups, or within a strict research protocol.

With the drafted paper, ESHRE hopes to send a clear message that the widespread implementation of several add-on treatments in fertility clinics is not good practice. This message will hopefully help clinicians and laboratory personnel to resist competitive pressures and refrain from offering and 'selling' these add on treatments to patients with the promise that they increase their chances of achieving a pregnancy or live birth.

On the other hand, there is a message of hope. The field of reproductive medicine is highly dynamic and yesterday's add-ons, such as ovarian stimulation, are today's good practice, as an article in the BMJ outlined. As such, today's add-ons could become tomorrow's good practice, but only if more research has provided quality evidence of efficiency and safety.

As part of the ESHRE procedures when preparing guidance documents, anyone considering themselves as a stakeholder can formulate feedback to the draft document and voice their suggestions. The full paper and information on participating in the stakeholder review process can be found on the ESHRE website. The final recommendations from ESHRE will be published in Spring 2023.