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STOP-OHSS Trial Simulation Report: Summary report on sample size calculation and operating characteristics of the group sequential trial
report
posted on 2023-06-08, 00:10 authored by Munyaradzi DimairoMunyaradzi Dimairo, Laura SuttonLaura Sutton, Tracey YoungTracey Young, Ellen LeeEllen Lee, Cara MooneyCara Mooney, David WhiteThis report summarises findings from a retrospective review of medical records of patients undergoing in-vitro fertilisation (IVF) treatments that inform the redesign of the STOP-OHSS trial (IRAS Number: 298619; SPONSOR Reference: STH20532; REC Reference: 22/LO/0015; ISRCTN: 71978064). The design features of the STOP-OHSS trial, sample size estimates, and the statistical behaviour of the design in addressing the research questions under different assumptions are presented. The limitations of the design and implications of early stopping on trial duration are also discussed.
Favourable ethical opinion for the STOP-OHSS Trial was granted by the London-South East Research Ethics Committee.
Funding
STOP-OHSS (Shaping and Trialling Outpatient Protocols for Ovarian Hyper-Stimulation Syndrome): A feasibility study and randomised controlled trial with internal pilot to assess the clinical and cost-effectiveness of earlier active management of OHSS
NIHR Evaluation Trials and Studies Coordinating Centre
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