《Fit-For-Fertility 研究方案：一项评估针对肥胖和不孕女性的生活方式干预的多中心随机对照试验》

Protocol of the Fit-For-Fertility study: a multicentre randomised controlled trial assessing a lifestyle programme targeting women with obesity and infertility.

机构信息

Department of Medicine, Division of Endocrinology, Université de Sherbrooke, Sherbrooke, Quebec, Canada.

Research Center of the Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.

出版信息

BMJ Open. 2022 Apr 19;12(4):e061554. doi: 10.1136/bmjopen-2022-061554.

DOI:10.1136/bmjopen-2022-061554

PMID:35440463

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9020282/

Abstract

INTRODUCTION

Women with obesity are at a higher risk of infertility as well as gestational and neonatal complications. Lifestyle changes are universally recommended for women with obesity seeking fertility treatments, but such intervention has only been assessed in very few robust studies. This study's objectives are therefore to assess the clinical outcomes and cost-effectiveness of an interdisciplinary lifestyle intervention (the Fit-For-Fertility Programme; FFFP) targeting women with obesity and subfertility in a diverse population.

METHODS AND ANALYSIS

This pragmatic multicentre randomised controlled trial (RCT) will include 616 women with obesity (body mass index ≥30 kg/m or ≥27 kg/m with polycystic ovary syndrome or at-risk ethnicities) who are evaluated at a Canadian fertility clinic for subfertility. Women will be randomised either to (1) the FFFP (experimental arm) alone for 6 months, and then in combination with usual care for infertility if not pregnant; or (2) directly to usual fertility care (control arm). Women in the intervention group benefit from the programme up to 18 months or, if pregnant, up to 24 months or the end of the pregnancy (whichever comes first). Women from both groups are evaluated every 6 months for a maximum of 18 months. The primary outcome is live birth rate at 24 months. Secondary outcomes include fertility, pregnancy and neonatal outcomes; lifestyle and anthropometric measures; and cost-effectiveness. Qualitative data collected from focus groups of participants and professionals will also be analysed.

ETHICS AND DISSEMINATION

This research study has been approved by the Research Ethics Board (REB) of (research coordinating centre) on 10 December 2018 and has been or will be approved successively by each participating centres' REB. This pragmatic RCT will inform decision-makers on improving care trajectories and policies regarding fertility treatments for women with obesity and subfertility.

TRIAL REGISTRATION NUMBER

NCT03908099.

PROTOCOL VERSION

1.1, 13 April 2019.

摘要

简介

肥胖女性不孕以及妊娠和新生儿并发症的风险更高。对于寻求生育治疗的肥胖女性，普遍建议进行生活方式改变，但这种干预措施仅在极少数强有力的研究中进行了评估。因此，本研究的目的是评估针对肥胖和生育力低下的女性的跨学科生活方式干预（生育力适应计划；FFFp）的临床结局和成本效益，该计划针对的是来自不同人群的女性。

方法和分析

这是一项实用的多中心随机对照试验（RCT），将包括 616 名肥胖女性（体重指数≥30kg/m 或≥27kg/m 且患有多囊卵巢综合征或有风险的种族），她们在加拿大生育诊所接受生育力低下的评估。女性将被随机分为（1）仅接受 FFFp（实验组）治疗 6 个月，如果未怀孕，则与常规不孕治疗联合治疗；或（2）直接接受常规生育治疗（对照组）。干预组的女性可受益于该计划长达 18 个月，或如果怀孕，则受益于该计划长达 24 个月或妊娠结束（以先到者为准）。两组女性均每 6 个月评估一次，最长 18 个月。主要结局是 24 个月时的活产率。次要结局包括生育、妊娠和新生儿结局；生活方式和人体测量指标；以及成本效益。还将分析从参与者和专业人员焦点小组收集的定性数据。