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, 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
N1 - Publisher Copyright:
© 2025 [Author/Employing Institution]
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. 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.
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. 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.
KW - consensus development study
KW - core outcome sets
KW - Delphi survey
KW - male infertility
KW - outcome measures
KW - outcomes
KW - randomized control trials
UR - http://www.scopus.com/inward/record.url?scp=105002783025&partnerID=8YFLogxK
U2 - 10.1016/j.fertnstert.2025.03.009
DO - 10.1016/j.fertnstert.2025.03.009
M3 - Article
C2 - 40237684
AN - SCOPUS:105002783025
SN - 0015-0282
VL - 123
SP - 1017
EP - 1028
JO - Fertility and Sterility
JF - Fertility and Sterility
IS - 6
ER -
