O-102 Add-ons in the ART clinic
Authors: Pinborg A , Bentzen J , Bozdag G , Ebner T , Harper J , Le Clef N , Moffett A , Norcross S , NP Polyzos , Rautakallio-Hokkanen S , Sfontouris I , Sermon K , Vermeulen N , Lundin K 
Published: June 2023

Study question

Which add-ons are effective and safe to use in the ART clinic?

Summary answer

More than thirty recommendations were formulated on the use of add-ons in diagnosis and diagnostic tests, laboratory tests and intervention, and clinical management.

What is known already

Treatment add-ons are not essential for the treatment but optional additional treatments that are sometimes offered on top of routine fertility treatment. There are a wide range of treatment add-ons on offer including tests, drugs, equipment, holistic or alternative therapies, laboratory and surgical interventions, but consistently, they aim to potentiate the effect of treatment or to lessen side effects herein improve pregnancy or live birth rate, reduce the risk of miscarriage or shorten the time to pregnancy. Evidence on whether some treatment add-ons are effective and safe is often missing or absent. Add-ons can be proven or evidence-based (or not) and can be at extra cost (or not), presumable they can be both beneficial and non-beneficial, as there may be absence of evidence to either.

Study design, size, duration

The ESHRE working group for good practice recommendations on add-ons in ART has produced recommendations useful for professionals, patients and policy makers and identified more than 30 add-ons and evaluated each one of them for efficiency and safety and wherever possible also costs. The literature was identified in a systematic search, was reviewed and critically appraised. In the absence of any clear scientific evidence, judgement was based on the professional experience and consensus of the development group. The guidelines are thus based on the best available evidence and expert agreement. Prior to publication, the guidelines were reviewed by independent international reviewers.

Participants/materials, setting, methods

Interventions were characterized in three sections: 1) Diagnosis and diagnostic tests, 2) Laboratory tests and intervention, and 3) Clinical management. Outcomes were efficacy (pregnancy or live birth rate), risk of miscarriage, time to pregnancy, costs, and safety/risk aspects. This lecture will focus on the recommendations relevant for the ART clinic including endometrial receptivity tests, assisted hatching, freeze-all (elective), ICSI (elective), uterine flushing and endometrial scratching.

Main results and the role of chance

The multidisciplinary development group formulated more than 30 recommendations. This lecture provides a summary of the recommendations of the add-ons currently used in fertility clinics. First it is described how an add-on is hypothesized to have beneficial effects on the IVF treatment, its efficacy, and its safety. While most add-ons are not recommended for the general population of ART patients, indications were formulated where specific patient populations might benefit.

The guideline has been in stakeholder review and is prepared for submission in 2023.

Limitations, reason for caution

Of the recommendations, none are based on high quality evidence and only a few are based on moderate quality evidence. Hence 90% of the recommendations are supported only by low quality RCTs, observational data, professional experience, or consensus of the development group.

Wider implications of the findings

These recommendations provide guidance to health care professionals and laboratory experts in the field of reproductive medicine, and will help towards safe and efficient ART treatment, where patients can participate in informed decision making with realistic expectations and are fully informed about their changes to pregnancy and live birth.

Study funding and competing interest(s)

All costs relating to the development process were covered from ESHRE funds. There was no external funding of the development process or manuscript production.

The authors have stated their conflicts of interest if any.