PREVENIR-IVF: study protocol for a prospective multicentre randomized open comparative trial, which explores the efficacy of a multidisciplinary platform reducing and preventing reprotoxic environmental exposures in subfertile couples on live birth rate after assisted reproduction treatment
Abstract
Background: A growing body of research suggests that parental exposure to environmental exposures (chemical, physical, organizational, stress) or abnormal body mass index (BMI) may impair couples' reproductive health. In many couples, these exposures in the workplace, at home (notably addictions, diet and physical activity) or in the domestic environment (stress, chemical and/or physical exposures) can be mitigated or eliminated by protective measures or by promoting behavioural changes. We postulate that in subfertile couples starting assisted reproduction treatment (ART), the systematic use of a multidisciplinary support platform aimed at detecting all environmental risk factors and implementing personalized preventive/corrective measures will improve ART outcomes and the spontaneous pregnancy rate.
Methods: On the basis of the French PREVENIR (PREVention ENvIronment Reproduction) platform network, we designed a prospective multicentre randomized open-label comparative study in 2112 subfertile couples eligible for in vitro fertilization (IVF). The primary objective is to evaluate the efficiency of using the PREVENIR platform before the first IVF/ICSI ("platform pathway", arm A) compared with standard ART without the PREVENIR platform ("standard pathway", arm B) by comparing the proportions of couples who obtain at least one live birth during the 24 months of follow-up. Patients will complete four self-report questionnaires assessing environmental exposures, quality of…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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