Time as an outcome measure in fertility-related clinical studies: long-awaited. Issue 8 (9th July 2020)

• Record Type: Journal Article
• Authors: Sunkara, Sesh K; Zheng, Wenjing; D'Hooghe, Thomas; Longobardi, Salvatore; Boivin, Jacky
• Is Part Of: Human reproduction. Volume 35:Issue 8(2020)
• Page Start: 1732
• Page End: 1739
• Publication Date: 2020-07-09
• Subjects: clinical trial design -- time -- medically assisted reproduction -- time to live birth -- statistical study design -- outcomes -- study design -- trial design -- endpoints; Human reproduction -- Periodicals; 618
• DOI: 10.1093/humrep/deaa138
• Languages: English
• ISSNs: 0268-1161

Abstract

Abstract: Time taken to achieve a live birth is an important consideration that is central to managing patient expectations during infertility treatment. However, time-related endpoints are not reported as standard in the majority of fertility-related clinical studies and there is no internationally recognized consensus definition for such endpoints. There is, therefore, a need for meaningful discussions around the selection of appropriate time-related treatment outcome measures for studies evaluating fertility treatments that will be relevant to diverse stakeholders (e.g. patients, healthcare professionals, clinical scientists, authorities and industry). Here, we provide a proposal for the evaluation of time-related outcome measures in fertility-related clinical studies, alongside associated definitions.