Clinical trial registration in fertility trials – a case for improvement?
Open Access
- 28 July 2017
- journal article
- research article
- Published by Oxford University Press (OUP) in Human Reproduction
- Vol. 32 (9), 1827-1834
- https://doi.org/10.1093/humrep/dex251
Abstract
What is the prevalence and source of prospectively and retrospectively registered and unregistered trials in fertility treatments? Trial registration is low and does not appear to be changing over the 5 years studied. Trial registration is associated with lower risk of bias than in unregistered trials. The Cochrane Gynaecology and Fertility Group's specialised register was searched on 5 November 2015 for randomised controlled trials (RCTs) published from January 2010 to December 2014. Eligible trials included randomised women or men for fertility treatments, were published in full text, and written in English. Two reviewers independently assessed trial registration status for each trial, by searching the publication, trial registries, and by contacting the original authors. Of 693 eligible RCTS, only 44% were registered trials. Of 309 registered trials, 21.7% were prospectively registered, 15.8% were registered within 6 months of first patient enrolment and 62.5% were retrospectively registered trials. Prospective trial registration by country varied from 0% to 100%. The highest frequency of prospective trial registration amongst the top 10 publishing countries was 31% in the Netherlands. Only English language trials were included in this review. Prospective trial registration is still low. Journals, funders and ethics committees could have a greater role to increase trial registration. University of Auckland. No competing interests.Keywords
Funding Information
- University of Auckland
This publication has 17 references indexed in Scilit:
- Clinical trial registration was not an indicator for low risk of biasJournal of Clinical Epidemiology, 2017
- Compliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reportingJournal of Clinical Epidemiology, 2016
- Registration Rates, Adequacy of Registration, and a Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials Published in Surgery JournalsAnnals of Surgery, 2014
- Trial Registration and Declaration of Registration by Authors of Randomized Controlled TrialsTransplantation, 2011
- Completeness and Changes in Registered Data and Reporting Bias of Randomized Controlled Trials in ICMJE Journals after Trial Registration PolicyPLOS ONE, 2011
- Comparison of Registered and Published Primary Outcomes in Randomized Controlled TrialsJAMA, 2009
- Clinical Trial RegistrationJAMA, 2004
- Registering clinical trials: an essential role for WHOThe Lancet, 2004
- Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses?The Lancet, 1998
- Publication Bias: The Problem That Won't Go AwayAnnals of the New York Academy of Sciences, 1993