core outcome set for future male infertility research: development of an international consensus.
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 MH., Lan N Vuong ., Wang AY., Wang R., Duffy JMN., Farquhar CM., Niederberger C.
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.