O-101 Add-ons in the ART lab
Authors: Lundin K , 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 , Pinborg A 
Published: June 2023

Abstract

Study question
Which laboratory based add-ons are effective and safe to use in ART treatment?

Summary answer
In total, more than thirty recommendations were formulated on the use of add-ons, with about a third being laboratory based tests or interventions

What is known already
Treatment add-ons are defined as 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 available, including diagnostic tests, drugs, equipment, holistic or alternative therapies, laboratory and surgical interventions, all claiming to potentiate the effect of the treatment and/or to lessen side effects, improve pregnancy or live birth rate, reduce the risk of miscarriage or shorten the time to pregnancy. Add-ons and can be at extra cost (or not), and evidence on efficacy and safety is often missing. Presumably they can be both beneficial or 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. More than 30 add-ons were identified, and evaluated for efficiency and safety, and wherever possible also for cost. The literature was identified in a systematic search, reviewed and critically appraised. In the absence of any clear scientific evidence, judgement was based on the professional experience and consensus of the multidisciplinary 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, cost, and safety/risk aspects. Some examples of add-ons in the group of laboratory tests and interventions are oocyte and sperm activation, mitochondria load and transfer, sperm selection, assisted hatching, genetic testing and addition of hyaluronic acid to media.

Main results and the role of chance
The guideline development group formulated more than 30 recommendations. This lecture will focus on the rationale and the recommendations of the laboratory add-ons currently used in fertility clinics. We will discuss the potential 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, where specific patient populations might benefit, indications were formulated.
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 aim to provide guidance to health care professionals and laboratory experts in the field of reproductive medicine, to help towards safe and efficient ART treatments for patients where they can participate in informed decision making with realistic expectations and be fully informed about their chances 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.