Protocol for developing a core outcome set for male infertility research: an international consensus development study

STUDY QUESTION: We aim to develop, disseminate and implement a minimum data set, known as a core outcome set, for future male infertility research.
WHAT IS KNOWN ALREADY: Research into male infertility can be challenging to design, conduct and report. Evidence from randomized trials can be difficult to interpret and of limited ability to inform clinical practice for numerous reasons. These may include complex
issues, such as variation in outcome measures and outcome reporting bias, as well as failure to consider the perspectives of men and their partners with lived experience of fertility problems. Previously, the Core Outcome Measure for Infertility Trials (COMMIT) initiative, an international consortium of researchers, healthcare professionals and people with fertility problems, has developed a core outcome set for general infertility research. Now, a bespoke core outcome set for male infertility is required to address the unique challenges pertinent to
male infertility research.
STUDY DESIGN, SIZE, DURATION: Stakeholders, including healthcare professionals, allied healthcare professionals, scientists, researchers and people with fertility problems, will be invited to participate. Formal consensus science methods will be used, including the
modified Delphi method, modified Nominal Group Technique and the National Institutes of Health’s consensus development conference.
PARTICIPANTS/MATERIALS, SETTING, METHODS: An international steering group, including the relevant stakeholders outlined above, has been established to guide the development of this core outcome set. Possible core outcomes will be identified by undertaking a systematic review of randomized controlled trials evaluating potential treatments for male factor infertility. These outcomes will be entered into a modified Delphi method. Repeated reflection and re-scoring should promote convergence towards consensus outcomes, which will be prioritized during a consensus development meeting to identify a final core outcome set. We will establish standardized definitions and recommend high-quality measurement instruments for individual core outcomes.


We aim to develop, disseminate and implement a minimum data set, known as a core outcome set, for future male infertility research.


Michael P. Rimmer, Ruth A. Howie, Richard A. Anderson, Christopher L.R. Barratt, Kurt T. Barnhart, Yusuf Beebeejaun, Ricardo Pimenta Bertolla, Siladitya Bhattacharya, Lars Bjorndahl, Pietro Bortoletto, Robert E. Brannigan, Astrid E.P. Cantineau, Ettore Caroppo, Barbara L. Collura, Kevin Coward, Michael L. Eisenberg, Christian De Geyter, Dimitrios G. Goulis, Ralf R. Henkel, Vu N.A. Ho, Alayman F. Hussein,
Carin Huyser, Jozef H. Kadijk, Mohan S. Kamath, Shadi Khashaba, Yoshitomo Kobori, Julia Kopeika, Tansu Kucuk, Saturnino Lujan, Thabo Christopher Matsaseng, Raj S. Mathur,
Kevin McEleny, Rod T. Mitchell, Ben W. Mol, Alfred M. Murage, Ernest H.Y. Ng, Allan Pacey,
Antti H. Perheentupa, Stefan Du Plessis, Nathalie Rives,
Ippokratis Sarris, Peter N. Schlegel, Majid Shabbir, Maciej Smiechowski, Venkatesh Subramanian, Sesh K. Sunkara, Basil C. Tarlarzis, Frank Tuttelmann, Andy Vail, Madelon van Wely, Monica H. Vazquez-Levin, Lan N. Vuong, Alex Y. Wang, Rui Wang, Armand Zini54,
Cindy M. Farquhar, Craig Niederberger and James M.N. Duffy


Journal: human reproduction
Pages: -
Year: 2022
DOI: 10.1093/hropen/hoac014

Further Study Information

Current Stage: Completed
Funding source(s): This work has been supported by the Urology Foundation small project award, 2021

Health Area

Disease Category: Urology

Disease Name: Male infertility

Target Population

Age Range: Unknown

Sex: Male

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Researchers

Study Type

- COS for clinical trials or clinical research


- Consensus meeting
- Delphi process
- Systematic review