Selective outcome reporting and sponsorship in randomized controlled trials in IVF and ICSI

AbstractSTUDY QUESTIONAre randomized controlled trials (RCTs) on IVF and ICSI subject to selective outcome reporting and is this related to sponsorship?SUMMARY ANSWERThere are inconsistencies, independent from sponsorship, in the reporting of primary outcome measures in the majority of IVF and ICSI trials, indicating selective outcome reporting.WHAT IS KNOWN ALREADYRCTs are subject to bias at various levels. Of these biases, selective outcome reporting is particularly relevant to IVF and ICSI trials since there is a wide variety of outcome measures to choose from. An established cause of reporting bias is sponsorship. It is, at present, unknown whether RCTs in IVF/ICSI are subject to selective outcome reporting and whether this is related with sponsorship.STUDY DESIGN, SIZE, DURATIONWe systematically searched RCTs on IVF and ICSI published between January 2009 and March 2016 in MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and the publisher subset of PubMed. We analysed 415 RCTs.PARTICIPANTS/MATERIALS, SETTING, METHODSPer included RCT, we extracted data on impact factor of the journal, sample size, power calculation, and trial registry and thereafter data on primary outcome measure, the direction of trial results and sponsorship.MAIN RESULTS AND THE ROLE OF CHANCEOf the 415 identified RCTs, 235 were excluded for our primary analysis, because the sponsorship was not reported. Of the 180 RCTs included in our analysis, 7 trials did not report on any primary...
Source: Human Reproduction - Category: Reproduction Medicine Source Type: research