Core Outcome Measures for Infertility Trials (COMMIT) - Male Infertility

A global initiative to develop a core outcome set for future male fertility trials led by clinicians, researchers and men with infertility.

Our Goal

We are looking to improve research into male infertility to enable healthcare professionals and researchers to provide better treatments for men with infertility.

Male Infertility COMMIT research

What is the problem?

Male factor infertility is a contributing factor in half of all couples who experience infertility. This is when a couple have been unable to become pregnant, despite 12 months of regular sexual intercourse. Infertility affects up to 1 in 6 couples trying to become pregnant.

Many new treatments for male infertility have been proposed in recent years; however, robust evidence as to how effective they are is variable. One way to assess these treatments is through randomised controlled trials, considered to be the gold standard study design to generate high quality evidence.

Combining evidence from different trials studying the same treatment, called a meta-analysis, means researchers can increase their confidence in the results. How data from several trials can be collected and analysed is limited by what outcomes these trials report.

Work to agree and standardise what clinical outcomes male infertility trials should report, or how these outcomes should be defined, is lacking. This can lead to researchers making arbitrary decisions on which outcomes to report in clinical trials. The range of different outcomes reported means it is challenging to combine the results of different trials which limits their potential to inform clinical practice.

Our Objective

We have formed a multinational group of healthcare professionals, researchers and men with infertility to lead this initiative.

These outcomes, called a core outcome set, will be developed by those with experience in male infertility. We welcome input from healthcare professionals, researchers and men with infertility to help identify the outcomes which should be reported in future male infertility trials.

This initiative will form an extension to the recently developed core outcome set for infertility trials, which lacked relevant stakeholder representation for male infertility. Once published, this outcome set will form part of the CROWN initiative, a researcher-led drive to harmonise outcome reporting in women's and newborn health research, currently adopted by over 80 peer-reviewed journals.

Our goal is to develop a core outcome set to be used in all future male infertility trials - this has now been achieved!

What we've done

Using a global team of clinicians, researchers, and patients with lived experience of infertility, we have identified the core outcomes to be included in future male infertility trials.

Over 300 participants from over 39 countries across the world have helped us to review over 79 individual core outcomes reported in randomised control trials over the last 10 years. From this we have now identified 3 main areas to collect data on and report, including:

Paternal outcomes - World Health Organisation semen analysis, including semen volume, pH, sperm concentration, total sperm number, total motility, progressive motility, vitality and sperm morphology.
Maternal outcomes - viable intrauterine pregnancy confirmed by ultrasound, to include singleton pregnancy, twin pregnancy, and higher multiple pregnancy. Pregnancy loss, including ectopic pregnancy, miscarriage, stillbirth, and termination of pregnancy. Live birth and gestational age of delivery.
Neonatal outcomes - Birth weight, neonatal mortaility and major congenital anomaly.

How should these be used

When desiginig future clinical trials, or conducting systematic reviews, these outcomes should be collected and reported. This means that clinical trials evaluating similar interventionscan be more easily compared when synthesising data across several studies. This will help us to understand if interventions are effective for treating male factor infertility, and if they should be used in clinical practice in the future. This will also help reduce research waste as we will identify which treatments do and do not work sooner, and avoid the need for further costly clinical trials.