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

Michael P. Rimmer; Ruth A. Howie; Richard A. Anderson; Christopher L. R. Barratt; Kurt T. Barnhart; Yusuf Beebeejaun; Ricardo Pimenta Bertolla; Pietro Bortoletto; Robert E. Brannigan; Astrid E. P. Cantineau; Ettore Caroppo; Barbara L. Collura; Kevin Coward; William Colin Duncan; Michael L. Eisenberg; Steven A. Gellatly; 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; Hajra Khattak; 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; M. nica H. Vazquez-Levin; Lan N. Vuong; Alex Y. Wang; Rui Wang; James M. N. Duffy; Cindy M. Farquhar; Craig Niederberger

doi:10.1016/j.fertnstert.2025.03.009

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

Michael P. Rimmer^*
, Ruth A. Howie
, Richard A. Anderson
, Christopher L. R. Barratt
, Kurt T. Barnhart
, Yusuf Beebeejaun
, Ricardo Pimenta Bertolla
, Pietro Bortoletto
, Robert E. Brannigan
, Astrid E. P. Cantineau
, Ettore Caroppo
, Barbara L. Collura
, Kevin Coward
, William Colin Duncan
, Michael L. Eisenberg
, Steven A. Gellatly
, 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, Hajra Khattak, 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, M. nica H. Vazquez-Levin, Lan N. Vuong, Alex Y. Wang, Rui Wang, James M. N. Duffy, Cindy M. Farquhar, Craig Niederberger

^*Corresponding author for this work

University of Edinburgh
University of Dundee
University of Pennsylvania
King's College London
Universidade Federal de São Paulo
Wayne State University
Boston IVF
Northwestern University
University of Groningen
Asl Bari
RESOLVE: The National Infertility Association
University of Oxford
Stanford University
University of Basel
Aristotle University of Thessaloniki
Imperial College London
University of the Western Cape
LogixX Pharma
My Duc Hospital
Minia University
University of Pretoria
Freya Dutch Infertility Association
Christian Medical College
University of New South Wales
IVFAustralia
University College London
Dokkyo Medical University
Guy's and St Thomas' NHS Foundation Trust
Acibadem Maslak Hospital
Hospital Universitario La Fe
Stellenbosch University
Manchester University NHS Foundation Trust
Newcastle upon Tyne Hospitals NHS Foundation Trust
Monash University
Harley Street Fertility Centre
The University of Hong Kong
University of Manchester
University of Turku
Mohammed Bin Rashid University of Medicine and Health Sciences
Université de Rouen Normandie
PLLC
Association for Infertility Treatment and Adoption Support “Our Stork”
Fertility Europe
University of Münster
Centre for Reproductive Medicine
Amsterdam UMC
Consejo Nacional de Investigaciones Científicas y Técnicas
University of Medicine and Pharmacy at Ho Chi Minh City
University of Technology Sydney
The University of Sydney
Barts Health NHS Trust
Cochrane Gynaecology and Fertility Group
The University of Auckland
University of Illinois at Chicago

Research output: Contribution to journal › Article › Academic › peer-review

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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.

Original language	English
Pages (from-to)	1017-1028
Number of pages	12
Journal	Human reproduction (Oxford, England)
Volume	123
Issue number	6
Early online date	2025
DOIs	https://doi.org/10.1016/j.fertnstert.2025.03.009 https://doi.org/10.1093/humrep/deaf039
Publication status	Published - Jun 2025

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Delphi survey
consensus development study
core outcome sets
male infertility
outcome measures
outcomes
randomized control trials

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Rimmer, M. P., Howie, R. A., Anderson, R. A., Barratt, C. L. R., Barnhart, K. T., Beebeejaun, Y., Bertolla, R. P., Bortoletto, P., Brannigan, R. E., Cantineau, A. E. P., Caroppo, E., Collura, B. L., Coward, K., Duncan, W. C., Eisenberg, M. L., Gellatly, S. A., Geyter, C. D., Goulis, D. G., Henkel, R. R., ... Niederberger, C. (2025). A core outcome set for future male infertility research: development of an international consensus. Human reproduction (Oxford, England), 123(6), 1017-1028. https://doi.org/10.1016/j.fertnstert.2025.03.009, https://doi.org/10.1093/humrep/deaf039

@article{63475ae7ea1f46ce8092031704e0ef7f,

title = "A core outcome set for future male infertility research: development of an international consensus",

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",

author = "Rimmer, \{Michael P.\} and Howie, \{Ruth A.\} and Anderson, \{Richard A.\} and Barratt, \{Christopher L. R.\} and Barnhart, \{Kurt T.\} and Yusuf Beebeejaun and Bertolla, \{Ricardo Pimenta\} and Pietro Bortoletto and Brannigan, \{Robert E.\} and Cantineau, \{Astrid E. P.\} and Ettore Caroppo and Collura, \{Barbara L.\} and Kevin Coward and Duncan, \{William Colin\} and Eisenberg, \{Michael L.\} and Gellatly, \{Steven A.\} and Geyter, \{Christian De\} and Goulis, \{Dimitrios G.\} and Henkel, \{Ralf R.\} and Ho, \{Vu N. A.\} and Hussein, \{Alayman F.\} and Carin Huyser and Kadijk, \{Jozef H.\} and Kamath, \{Mohan S.\} and Shadi Khashaba and Hajra Khattak and Yoshitomo Kobori and Julia Kopeika and Tansu Kucuk and Saturnino Luj{\'a}n and Matsaseng, \{Thabo Christopher\} and Mathur, \{Raj S.\} and Kevin McEleny and Mitchell, \{Rod T.\} and Mol, \{Ben W.\} and Murage, \{Alfred M.\} and Ng, \{Ernest H. Y.\} and Allan Pacey and Perheentupa, \{Antti H.\} and \{du Plessis\}, Stefan and Nathalie Rives and Ippokratis Sarris and Schlegel, \{Peter N.\} and Majid Shabbir and Maciej {\'S}miechowski and Venkatesh Subramanian and Sunkara, \{Sesh K.\} and Tarlarzis, \{Basil C.\} and Frank T{\"u}ttelmann and Andy Vail and \{van Wely\}, Madelon and Vazquez-Levin, \{M. nica H.\} and \{Lan N. Vuong\} and Wang, \{Alex Y.\} and Rui Wang and Duffy, \{James M. N.\} and Farquhar, \{Cindy M.\} and Craig Niederberger",

note = "Publisher Copyright: {\textcopyright} 2025 [Author/Employing Institution]",

year = "2025",

month = jun,

doi = "10.1016/j.fertnstert.2025.03.009",

language = "English",

volume = "123",

pages = "1017--1028",

journal = "Human reproduction (Oxford, England)",

issn = "0268-1161",

publisher = "Oxford University Press",

number = "6",

}

Rimmer, MP, Howie, RA, Anderson, RA, Barratt, CLR, Barnhart, KT, Beebeejaun, Y, Bertolla, RP, Bortoletto, P, Brannigan, RE, Cantineau, AEP, Caroppo, E, Collura, BL, Coward, K, Duncan, WC, Eisenberg, ML, Gellatly, SA, Geyter, CD, Goulis, DG, Henkel, RR, Ho, VNA, Hussein, AF, Huyser, C, Kadijk, JH, Kamath, MS, Khashaba, S, Khattak, H, Kobori, Y, Kopeika, J, Kucuk, T, Luján, S, Matsaseng, TC, Mathur, RS, McEleny, K, Mitchell, RT, Mol, BW, Murage, AM, Ng, EHY, Pacey, A, Perheentupa, AH, du Plessis, S, Rives, N, Sarris, I, Schlegel, PN, Shabbir, M, Śmiechowski, M, Subramanian, V, Sunkara, SK, Tarlarzis, BC, Tüttelmann, F, Vail, A, van Wely, M, Vazquez-Levin, MNH, Lan N. Vuong, Wang, AY, Wang, R, Duffy, JMN, Farquhar, CM & Niederberger, C 2025, 'A core outcome set for future male infertility research: development of an international consensus', Human reproduction (Oxford, England), vol. 123, no. 6, pp. 1017-1028. https://doi.org/10.1016/j.fertnstert.2025.03.009, https://doi.org/10.1093/humrep/deaf039

TY - JOUR

T1 - A core outcome set for future male infertility research

T2 - development of an international consensus

AU - Rimmer, Michael P.

AU - Howie, Ruth A.

AU - Anderson, Richard A.

AU - Barratt, Christopher L. R.

AU - Barnhart, Kurt T.

AU - Beebeejaun, Yusuf

AU - Bertolla, Ricardo Pimenta

AU - Bortoletto, Pietro

AU - Brannigan, Robert E.

AU - Cantineau, Astrid E. P.

AU - Caroppo, Ettore

AU - Collura, Barbara L.

AU - Coward, Kevin

AU - Duncan, William Colin

AU - Eisenberg, Michael L.

AU - Gellatly, Steven A.

AU - Geyter, Christian De

AU - Goulis, Dimitrios G.

AU - Henkel, Ralf R.

AU - Ho, Vu N. A.

AU - Hussein, Alayman F.

AU - Huyser, Carin

AU - Kadijk, Jozef H.

AU - Kamath, Mohan S.

AU - Khashaba, Shadi

AU - Khattak, Hajra

AU - Kobori, Yoshitomo

AU - Kopeika, Julia

AU - Kucuk, Tansu

AU - Luján, Saturnino

AU - Matsaseng, Thabo Christopher

AU - Mathur, Raj S.

AU - McEleny, Kevin

AU - Mitchell, Rod T.

AU - Mol, Ben W.

AU - Murage, Alfred M.

AU - Ng, Ernest H. Y.

AU - Pacey, Allan

AU - Perheentupa, Antti H.

AU - du Plessis, Stefan

AU - Rives, Nathalie

AU - Sarris, Ippokratis

AU - Schlegel, Peter N.

AU - Shabbir, Majid

AU - Śmiechowski, Maciej

AU - Subramanian, Venkatesh

AU - Sunkara, Sesh K.

AU - Tarlarzis, Basil C.

AU - Tüttelmann, Frank

AU - Vail, Andy

AU - van Wely, Madelon

AU - Vazquez-Levin, M. nica H.

AU - Lan N. Vuong, null

AU - Wang, Alex Y.

AU - Wang, Rui

AU - Duffy, James M. N.

AU - Farquhar, Cindy M.

AU - Niederberger, Craig

PY - 2025/6

Y1 - 2025/6

N2 - 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.

AB - 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.

KW - Delphi survey

KW - consensus development study

KW - core outcome sets

KW - male infertility

KW - outcome measures

KW - outcomes

KW - randomized control trials

UR - https://www.scopus.com/pages/publications/105002783025

U2 - 10.1016/j.fertnstert.2025.03.009

DO - 10.1016/j.fertnstert.2025.03.009

M3 - Article

C2 - 40237684

SN - 0268-1161

VL - 123

SP - 1017

EP - 1028

JO - Human reproduction (Oxford, England)

JF - Human reproduction (Oxford, England)

IS - 6

ER -

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

Abstract

UN SDGs

Keywords

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