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; Mónica 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. HoAlayman 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, Mónica H. Vazquez-Levin, Lan N. Vuong, Alex Y. Wang, Rui Wang, James M.N. Duffy, Cindy M. Farquhar, Craig Niederberger

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

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.
Intervention or 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
Journal	Fertility and Sterility
Early online date	16 Apr 2025
DOIs	https://doi.org/10.1016/j.fertnstert.2025.03.009
Publication status	E-pub ahead of print - 16 Apr 2025

Keywords / Materials (for Non-textual outputs)

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

Access to Document

10.1016/j.fertnstert.2025.03.009Licence: CC BY-NC-ND

https://linkinghub.elsevier.com/retrieve/pii/S0015028225001578

Protecting spermatogonial stem cells from chemotherapy-induced damage for fertility preservation in childhood cancer
Mitchell, R. (Principal Investigator) & Carragher, N. (Co-investigator)
UKRI (formerly RCUK)
1/05/24 → 30/04/27
Project: Research

Cite this

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., De Geyter, C., Goulis, D. G., Henkel, R. R., ... Niederberger, C. (2025). A core outcome set for future male infertility research: development of an international consensus. Fertility and Sterility. Advance online publication. https://doi.org/10.1016/j.fertnstert.2025.03.009

@article{9b13644395754b4f8f3096a343336730,

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

abstract = "ObjectiveTo develop a core outcome set for male infertility trials.DesignA two-round Delphi survey and consensus development workshop were undertaken with healthcare professionals, researchers and clinicians globally.Subjects334 participants from 39 countries participated in the Delphi Survey, while 44 participants from 21 countries participated in the consensus development workshop.Intervention or ExposureNAMain Outcome MeasuresThe 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.ResultsThe 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.ConclusionEmbedding 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 NumberCore 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 {De Geyter}, Christian 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{\'o}nica H.} and Vuong, {Lan N.} and Wang, {Alex Y.} and Rui Wang and Duffy, {James M.N.} and Farquhar, {Cindy M.} and Craig Niederberger",

year = "2025",

month = apr,

day = "16",

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

language = "English",

journal = "Fertility and Sterility",

issn = "0015-0282",

publisher = "Elsevier Inc.",

}

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, De Geyter, C, 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, MH, Vuong, LN, 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', Fertility and Sterility. https://doi.org/10.1016/j.fertnstert.2025.03.009

TY - JOUR

T1 - A core outcome set for future male infertility research: 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 - De Geyter, Christian

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, Mónica H.

AU - Vuong, Lan N.

AU - Wang, Alex Y.

AU - Wang, Rui

AU - Duffy, James M.N.

AU - Farquhar, Cindy M.

AU - Niederberger, Craig

PY - 2025/4/16

Y1 - 2025/4/16

N2 - ObjectiveTo develop a core outcome set for male infertility trials.DesignA two-round Delphi survey and consensus development workshop were undertaken with healthcare professionals, researchers and clinicians globally.Subjects334 participants from 39 countries participated in the Delphi Survey, while 44 participants from 21 countries participated in the consensus development workshop.Intervention or ExposureNAMain Outcome MeasuresThe 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.ResultsThe 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.ConclusionEmbedding 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 NumberCore Outcome Measures in Effectiveness Trials (COMET) initiative registration No: 1586. Available at www.comet-initiative.org/Studies/Details/1586.

AB - ObjectiveTo develop a core outcome set for male infertility trials.DesignA two-round Delphi survey and consensus development workshop were undertaken with healthcare professionals, researchers and clinicians globally.Subjects334 participants from 39 countries participated in the Delphi Survey, while 44 participants from 21 countries participated in the consensus development workshop.Intervention or ExposureNAMain Outcome MeasuresThe 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.ResultsThe 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.ConclusionEmbedding 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 NumberCore 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

U2 - 10.1016/j.fertnstert.2025.03.009

DO - 10.1016/j.fertnstert.2025.03.009

M3 - Article

SN - 0015-0282

JO - Fertility and Sterility

JF - Fertility and Sterility

ER -

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

Abstract

Keywords / Materials (for Non-textual outputs)

Access to Document

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Projects

Protecting spermatogonial stem cells from chemotherapy-induced damage for fertility preservation in childhood cancer

Cite this