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ABSTRACT: Introduction
Dietary and/or physical activity interventions are often recommended for women with overweight or obesity as the first step prior to fertility treatment. However, randomised controlled trials (RCTs) so far have shown inconsistent results. Therefore, we propose this individual participant data meta-analysis (IPDMA) to evaluate the effectiveness and safety of dietary and/or physical activity interventions in women with infertility and overweight or obesity on reproductive, maternal and perinatal outcomes and to explore if there are subgroup(s) of women who benefit from each specific intervention or their combination (treatment-covariate interactions).Methods and analysis
We will include RCTs with dietary and/or physical activity interventions as core interventions prior to fertility treatment in women with infertility and overweight or obesity. The primary outcome will be live birth. We will search MEDLINE, Embase, Cochrane Central Register of Controlled Trials and trial registries to identify eligible studies. We will approach authors of eligible trials to contribute individual participant data (IPD). We will perform risk of bias assessments according to the Risk of Bias 2 tool and a random-effects IPDMA. We will then explore treatment-covariate interactions for important participant-level characteristics.Ethics and dissemination
Formal ethical approval for the project (Venus-IPD) was exempted by the medical ethics committee of the University Medical Center Groningen (METc code: 2021/563, date: 17 November 2021). Data transfer agreement will be obtained from each participating institute/hospital. Outcomes will be disseminated internationally through the collaborative group, conference presentations and peer-reviewed publication.Prospero registration number
CRD42021266201.
SUBMITTER: Evans-Hoeker E
PROVIDER: S-EPMC9644352 | biostudies-literature | 2022 Nov
REPOSITORIES: biostudies-literature
Evans-Hoeker Emily E Wang Zheng Z Groen Henk H Cantineau Astrid E P AEP Thurin-Kjellberg Ann A Bergh Christina C Laven Joop S E JSE Dietz de Loos Alexandra A Jiskoot Geranne G Baillargeon Jean-Patrice JP Palomba Stefano S Sim Kyra K Moran Lisa J LJ Espinós Juan J JJ Moholdt Trine T Rothberg Amy E AE Shoupe Donna D Hoek Annemieke A Legro Richard S RS Mol Ben W BW Wang Rui R
BMJ open 20221107 11
<h4>Introduction</h4>Dietary and/or physical activity interventions are often recommended for women with overweight or obesity as the first step prior to fertility treatment. However, randomised controlled trials (RCTs) so far have shown inconsistent results. Therefore, we propose this individual participant data meta-analysis (IPDMA) to evaluate the effectiveness and safety of dietary and/or physical activity interventions in women with infertility and overweight or obesity on reproductive, mat ...[more]