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.
Keywords: Fertility, Male Fertility, Infertility, Andrology, Urology, Reproductive
Trial Registration Number
Core Outcome Measures in Effectiveness Trials (COMET) initiative registration No: 1586. Available at www.comet-initiative.org/Studies/Details/1586.
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 Smiechowski, 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
Disease Category: Pregnancy & childbirth
Disease Name: Male infertility
Age Range: 15 - 55
Sex: Male
Nature of Intervention: Any
- Charities
- Clinical experts
- Conference participants
- Consumers (patients)
- Epidemiologists
- Governmental agencies
- Journal editors
- Methodologists
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Policy makers
- Regulatory agency representatives
- Researchers
- Service commissioners
- Service providers
- Service users
- Statisticians
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Literature review