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. 2025 Jun;123(6):1017-1028.
doi: 10.1016/j.fertnstert.2025.03.009. Epub 2025 Apr 16.

A core outcome set for future male infertility research: development of an international consensus

Michael P Rimmer  1 , Ruth A Howie  2 , Richard A Anderson  3 , Christopher L R Barratt  4 , Kurt T Barnhart  5 , Yusuf Beebeejaun  6 , Ricardo Pimenta Bertolla  7 , Pietro Bortoletto  8 , Robert E Brannigan  9 , Astrid E P Cantineau  10 , Ettore Caroppo  11 , Barbara L Collura  12 , Kevin Coward  13 , William Colin Duncan  3 , Michael L Eisenberg  14 , Steven A Gellatly  4 , Christian De Geyter  15 , Dimitrios G Goulis  16 , Ralf R Henkel  17 , Vu N A Ho  18 , Alayman F Hussein  19 , Carin Huyser  20 , Jozef H Kadijk  21 , Mohan S Kamath  22 , Shadi Khashaba  23 , Hajra Khattak  24 , Yoshitomo Kobori  25 , Julia Kopeika  26 , Tansu Kucuk  27 , Saturnino Luján  28 , Thabo Christopher Matsaseng  29 , Raj S Mathur  30 , Kevin McEleny  31 , Rod T Mitchell  32 , Ben W Mol  33 , Alfred M Murage  34 , Ernest H Y Ng  35 , Allan Pacey  36 , Antti H Perheentupa  37 , Stefan Du Plessis  38 , Nathalie Rives  39 , Ippokratis Sarris  40 , Peter N Schlegel  41 , Majid Shabbir  26 , Maciej Śmiechowski  42 , Venkatesh Subramanian  6 , Sesh K Sunkara  43 , Basil C Tarlarzis  16 , Frank Tüttelmann  44 , Andy Vail  45 , Madelon van Wely  46 , Mónica H Vazquez-Levin  47 , Lan N Vuong  48 , Alex Y Wang  49 , Rui Wang  50 , James M N Duffy  51 , Cindy M Farquhar  52 , Craig Niederberger  53
Affiliations

A core outcome set for future male infertility research: development of an international consensus

Michael P Rimmer et al. Fertil Steril. 2025 Jun.

Abstract

Objective: To develop a core outcome set for male infertility trials.

Design: A two-round Delphi survey and consensus development workshop were undertaken with healthcare professionals, researchers and clinicians globally.

Subjects: 334 participants from 39 countries participated in the Delphi Survey, while 44 participants from 21 countries participated in the consensus development workshop.

Exposure: NA MAIN OUTCOME MEASURES: The core outcome set for male infertility trials has been developed by the inclusion of specific male-factor outcomes in addition to the general infertility core outcome set which focuses on female-factor outcomes.

Results: The outcomes identified include assessment of semen using the World Health Organisation recommendations for semen analysis; viable intrauterine pregnancy confirmed by ultrasound (accounting for singleton, twin and higher multiple pregnancies); pregnancy loss (accounting for ectopic pregnancy, miscarriage, stillbirth and termination of pregnancy); live birth; gestational age at delivery; birthweight; neonatal mortality; and major congenital anomaly. Although not a requirement as part of the core outcome set, other outcomes were identified as potentially useful in certain study settings.

Conclusion: Embedding the core outcome set within RCTs and systematic reviews should ensure the comprehensive selection, collection and reporting of core outcomes, which are inconsistently reported at present. Research funding bodies, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement, and over 80 specialty journals, including the Cochrane Gynaecology and Fertility Group, Fertility and Sterility and Human Reproduction, have committed to implementing this core outcome set for male infertility trials.

Trial registration number: Core Outcome Measures in Effectiveness Trials (COMET) initiative registration No: 1586. Available at www.comet-initiative.org/Studies/Details/1586.

Keywords: Delphi survey; consensus development study; core outcome sets; male infertility; outcome measures; outcomes; randomized control trials.

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Conflict of interest statement

Conflict of interest C.L.R.B. is the co-editor in chief of Human Reproduction and 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. R.P.B. receives royalties from Flow diagnósticos. M.L.E. is an advisor to the companies Hannah, Illumicell, Next, Legacy, Doveras, Vseat and received a consultancy fee for this. B.W.M. is a paid consultant for Norgine and Organon and has received research funding from Ferring and Merck, he also receives consultancy and travel support from Merck. R.R.H. received royalties from Elsevier for a book, consultancy fees from Glyciome, and presentation fees from GryNumber Health and Aytu Bioscience. 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. has been an associate editor with Human Reproduction Open. K.Mc.E. received funding to attend Fertility 2025 by the British Fertility Society and is the Chair of the British Fertility Society. He is a member of the HFEA’s Scientific and Clinical Advances Advisory Committee and a Committee Member of the NICE Fertility Problems Guideline Group. M.H.V.L. receives consultation fees for the WHO Manual Spanish translation, and travel expenses for the ESHRE MRHI meeting in Budapest. She is a member of the editorial board for Fertility & Sterility, F&S Science, Human Reproduction, and Frontiers in Endocrinology. She is also a panel member of the World Health Organization (WHO) Human Reproduction Programme (HRP) Research Project Review Panel. R.S.M. is a member of the NICE Guideline Committee on Fertility and former chair of the British Fertility Society. A. Perheentupa receives an honoraria for lecturing from Merck for the Tackling Infertility manifest, Gedeon Richter & Ferring. A. Perheentupa declares lecture honoraria from Merck, Gideon Richter, and Ferring; and payment from Merck for the Tackling Infertility manifesto. A. Pacey receives consultancy fees for Carrot Fertility and Cryos International as well as lecturing for IBSA Institut Biochimique SA and Mealis Group—all fees paid to The University of Manchester. He is also a Trustee of Progress Educational. Trust (Charity Number 1139856) and Chairman of UKNEQAS Reproductive Sciences Advisory Committee. F.T. is the recipient of a Bayer research grant, as well as DFG Clinical Research Unit ‘Male Germ Cells’ (CRU326, project number 329621271) and BMBF Junior Scientist Research Centre ‘ReproTrack.MS’ (grant 01GR2303), he has received travel support from IBSA and Organon. M.v.W. is the Editor-in-Chief of Human Reproduction Update. R.W. is a former Deputy Editor of Human Reproduction and is currently a Deputy Editor of Human Reproduction Update.

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