We aim to develop, disseminate and implement a minimum data set, known as a core outcome set, for future male infertility research.
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.
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.
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.
This work has been supported by the Urology Foundation small project award, 2021. C.L.R.B. is the recipient of a BMGF grant and received consultancy fees from Exscentia and Exceed sperm testing, paid to the University of Dundee and speaking fees or honoraria paid personally by Ferring, Copper Surgical and RBMO. S.B. received royalties from Cambridge University Press, Speaker honoraria for Obstetrical and Gynaecological Society of Singapore, Merk SMART Masterclass and Merk FERRING Forum, paid to the University of Aberdeen. Payment for leadership roles within NHS Grampian, previously paid to self, now paid to University of Aberdeen. An Honorarium is received as Editor in Chief of Human Reproduction Open. M.L.E. is an advisor to the companies Hannah and Ro. B.W.M. received an investigator grant from the NHMRC, No: GNT1176437 is a paid consultant for ObsEva and has received research funding from Ferring and Merck. R.R.H. received royalties from Elsevier for a book, consultancy fees from Glyciome, and presentation fees from GryNumber Health and Aytu Bioscience. Aytu Bioscience also funded MiOXYS systems and sensors. Attendance at Fertility 2020 and Roadshow South Africa by Ralf Henkel was funded by LogixX Pharma Ltd. R.R.H. is also Editor in Chief of Andrologia and has been an employee of LogixX Pharma Ltd. since 2020. M.S.K. is an associate editor with Human Reproduction Open. K.Mc.E. received an honoraria for lectures from Bayer and Pharmasure in 2019 and payment for an ESHRE grant review in 2019. His attendance at ESHRE 2019 and AUA 2019 was sponsored by Pharmasure and Bayer, respectively. The remaining authors declare no competing interests.
Core Outcome Measures in Effectiveness Trials (COMET) initiative registration No: 1586. Available at www.comet-initiative.org/Studies/Details/1586.
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Human reproduction open. 2022 Mar 16*** epublish ***
Michael P Rimmer, Ruth A Howie, Richard A Anderson, Christopher L R Barratt, Kurt T Barnhart, Yusuf Beebeejaun, Ricardo Pimenta Bertolla, Siladitya Bhattacharya, Lars Björndahl, 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 Luján, 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 Śmiechowski, Venkatesh Subramanian, Sesh K Sunkara, Basil C Tarlarzis, Frank Tüttelmann, Andy Vail, Madelon van Wely, Mónica H Vazquez-Levin, Lan N Vuong, Alex Y Wang, Rui Wang, Armand Zini, Cindy M Farquhar, Craig Niederberger, James M N Duffy
MRC Centre for Reproductive Health, Queens Medical Research Institute, University of Edinburgh, Edinburgh, UK., Edinburgh Fertility Centre, Simpsons Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh, UK., Reproductive Medicine Research Group, University of Dundee, Ninewells Hospital and Medical School, Dundee, UK., Department of Obstetrics and Gynaecology, University of Pennsylvania School of Medicine, Philadelphia, PA, USA., King's Fertility, The Fetal Medicine Research Unit, King's College London, London, UK., Division of Urology, Department of Surgery, Universidade Federal de Sao Paulo, Sao Paulo, Brazil., University of Aberdeen, Aberdeen, UK., ANOVA-Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden., The Ronald O. Perelman and Claudia Cohen Centre for Reproductive Medicine, Weill Cornell Medicine, New York, NY, USA., Northwestern University, Feinberg School of Medicine, Chicago, IL, USA., University of Groningen, University Medical Centre, Groningen, Centre of Reproductive Medicine, Groningen, Netherlands., Asl Bari, Reproductive Unit and Andrology Clinic, Conversano (Ba), Italy., RESOLVE: The National Infertility Association, McLean, VA, USA., Nuffield Department of Women's and Reproductive Health, University of Oxford, Oxford, UK., Stanford University, Stanford, CA, USA., Reproductive Medicine and Gynaecological Endocrinology (RME), University Hospital, University of Basel, Basel, Switzerland., Units of Human Reproduction and Reproductive Endocrinology, 1st Department of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece., Department of Digestion, Metabolism and Reproduction, Imperial College London, London, UK., IVFMD, My Duc Hospital, HOPE Research Centre, My Duc Hospital, Ho Chi Minh City, Vietnam., Minia University, Minia, Egypt., Reproductive Biology Laboratory, Department of Obstetrics and Gynaecology, University of Pretoria, Steve Biko Academic Hospital, Pretoria, South Africa., Freya-Dutch Patient Association for Infertility, Gorinchem, The Netherlands., Christian Medical College, Vellore, India., University of New South Wales, Sydney, Australia., Dokkyo Medical University Saitama Medical Center, Mibu, Japan., Guy's and St Thomas Hospital, London, UK., Acibadem Maslak Hospital, Istanbul, Turkey., Urology Department, Hospital Universitari i Politècnic La Fe, Valencia, Spain., Stellenbosch University, Stellenbosch, Western Cape, South Africa., Manchester University Foundation Trust, Manchester Academic Health Sciences Centre, Manchester, UK., Newcastle Fertility, The Newcastle upon Tyne Hospitals NHS Trust, Newcastle upon Tyne, UK., Harley Street Fertility Centre, Nairobi, Kenya., Department of Obstetrics and Gynaecology, The University of Hong Kong, Hong Kong Special Administrative Region, China., Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK., Department of Obstetrics and Gynaecology, University of Turku and Turku University Hospital, Turku, Finland., College of Medicine, Mohammed Bin Rashid University of Medicine and Health Sciences, Dubai, UAE., Rouen University Hospital, Biology of Reproduction-CECOS Laboratory, Rouen, France., Association for Infertility Treatment and Adoption Support "Our Stork", Warsaw, Poland., Faculty of Life Sciences and Medicine, King's College London, London, UK., Institute of Reproductive Genetics, University of Münster, Münster, Germany., Centre for Biostatistics, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK., Netherlands Satellite of the Cochrane Gynaecology and Fertility Group, Centre for Reproductive Medicine, Amsterdam, Netherlands., Laboratorio de Estudios de Interacción Celular en Reproducción y Cáncer, Instituto de Biología y Medicina Experimental (IBYME), Consejo Nacional de Investigaciones Científicas y Técnicas de Argentina (CONICET), Fundación IBYME (FIBYME), Buenos Aires, Argentina., Department of Obstetrics and Gynaecology, University of Medicine and Pharmacy at Ho Chi Minh City, Ho Chi Minh City, Vietnam., Faculty of Health, University of Technology Sydney, Ultimo, Australia., Department of Obstetrics and Gynaecology, Monash University, Melbourne, Australia., Division of Urology, Department of Surgery, McGill University, Montreal, Quebec, Canada., Cochrane Gynaecology and Fertility Group, University of Auckland, Auckland, New Zealand., Department of Urology, University of Illinois at Chicago, Chicago, IL, USA.