考虑围孕期环境的治疗性多生活方式干预在不孕夫妇管理中的有效性：一项随机对照试验的研究设计 - PEPCI 研究。
Effectiveness of a therapeutic multiple-lifestyle intervention taking into account the periconceptional environment in the management of infertile couples: study design of a randomized controlled trial - the PEPCI study.
机构信息
Saint Antoine Research Center, INSERM équipe Lipodystrophies génétiques et acquises, Service de biologie de la reproduction-CECOS, AP-HP, Hôpital Tenon, Sorbonne Université, 4 rue de la Chine, F-75020, Paris, France.
Unité de Recherche Clinique et Département de Santé Publique, Assistance Publique - Hôpitaux de Paris, Hôpital Ambroise Paré, Boulogne, France.
出版信息
BMC Pregnancy Childbirth. 2020 May 26;20(1):322. doi: 10.1186/s12884-020-2855-9.
BACKGROUND
Infertility is defined as the inability to conceive after 12 months of unprotected intercourse. It affects approximately one in six couples seeking pregnancy in France or western countries. Many lifestyle factors of the couples' pre and peri-conceptional environment (weight, diet, alcohol, tobacco, coffee, drugs, physical activity, stress, sleep…) have been identified as risk factors for infertility in both males and females. The high prevalence rates of unhealthy diets and lifestyles in the reproductive population of industrialized countries are worrisome. Nevertheless, adoption of a healthy lifestyle may improve fertility but lifestyle changes are difficult to achieve and to maintain due notably to behavioral factors.
METHODS
Consequently, we decided to propose an interventional study aimed at improving the quality of life of infertile couples before the start of assisted reproductive technology treatment. It is a randomized controlled multicentre trial. Both members of the couples are involved in an integrated global care program (PEPCI for "Parcours Environnement PériConceptionnel en Infertilité") vs. usual care. This global intervention not only considers diet and/or physical activity but follows a holistic approach, including a multidisciplinary assessment to address complete physical, psychological and social well-being. According to patient needs, this includes interventions on weight, exercise, diet, alcohol and drugs, mental and social health.
DISCUSSION
The main objective of trial is to demonstrate that periconceptional multidisciplinary care has a positive impact on reproductive functions. We will also focus on feasibility, acceptance, compliance and conditions of success of a multifaceted lifestyle intervention.
TRIAL REGISTRATION
The trial was registered at ClinicalTrials.gov, Identifier: NCT02961907 on November 11, 2016.
背景
不孕定义为在无保护性交 12 个月后仍无法怀孕。它影响了大约六分之一在法国或西方国家寻求怀孕的夫妇。许多夫妇的预孕期和孕期环境的生活方式因素（体重、饮食、酒精、烟草、咖啡、药物、体力活动、压力、睡眠……）已被确定为男性和女性不孕的危险因素。在工业化国家的生殖人群中，不健康饮食和生活方式的高流行率令人担忧。然而，采用健康的生活方式可能会提高生育能力，但由于行为因素，生活方式的改变很难实现和维持。
方法
因此，我们决定提出一项干预性研究，旨在在开始辅助生殖技术治疗之前提高不孕夫妇的生活质量。这是一项随机对照多中心试验。夫妇双方都参与了一个综合的整体护理方案（PEPCI 代表“不孕患者的围孕期环境护理”）与常规护理。这种整体干预不仅考虑了饮食和/或体力活动，还遵循了一种整体方法，包括多学科评估，以解决全面的身体、心理和社会福祉。根据患者的需求，这包括针对体重、运动、饮食、酒精和药物、精神和社会健康的干预措施。
讨论
试验的主要目的是证明围孕期多学科护理对生殖功能有积极影响。我们还将关注多方面生活方式干预的可行性、可接受性、依从性和成功条件。
试验注册
该试验于 2016 年 11 月 11 日在 ClinicalTrials.gov 上注册，标识符：NCT02961907。
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