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非药物干预超重/肥胖多囊卵巢综合征女性排卵和妊娠结局的效果:系统评价和网络荟萃分析方案。

Effect of non-pharmacological interventions for overweight/obese women with polycystic ovary syndrome on ovulation and pregnancy outcomes: a protocol for a systematic review and network meta-analysis.

机构信息

Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu, China.

Infertility Clinic, Chengdu Xinan Gynecological Hospital, Chengdu, China.

出版信息

BMJ Open. 2022 Jun 8;12(6):e059090. doi: 10.1136/bmjopen-2021-059090.

DOI:10.1136/bmjopen-2021-059090
PMID:35676007
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9185587/
Abstract

INTRODUCTION

Most overweight/obese women with polycystic ovary syndrome (PCOS) have infertility issues which are difficult to treat. Non-pharmacological interventions used for the management of infertility include lifestyle interventions, acupuncture therapies and nutritional supplements. These interventions have been reported to be beneficial in alleviating infertility among overweight women with PCOS. However, effect and safety of these non-pharmacological interventions vary, and there is no standard method of clinical application. Therefore, it is necessary to conduct a systematic review and network meta-analysis (NMA) to rank these non-pharmacological interventions in terms of effect and determine which one is more effective for clinical application.

METHODS AND ANALYSIS

We will retrieve eight databases including Cochrane Library, Medline, Embase, PsycINFO, Chinese National Knowledge Infrastructure, WanFang Data, the Chongqing VIP Database and China Biology Medicine disc from their inceptions onwards. In addition, four clinical trial registries and the related references will be manually retrieved. The primary outcome will be clinical pregnancy. Live birth, ovulation, pregnancy loss, multiple pregnancy and adverse events related to interventions will be considered as the secondary outcomes. STATA software V.15.0 and Aggregate Data Drug Information System V.1.16.8 will be used to conduct pairwise meta-analysis and NMA. The Grading of Recommendations Assessment, Development and Evaluation system will be adopted to evaluate the certainty of evidence.

ETHICS AND DISSEMINATION

Ethical approval will not be required because the study will not include the original information of participants. The results will be published in a peer-reviewed journal or disseminated in relevant conferences.

PROSPERO REGISTRATION NUMBER

CRD42021283110.

摘要

简介

大多数患有多囊卵巢综合征(PCOS)的超重/肥胖女性都存在难以治疗的不孕问题。用于治疗不孕的非药物干预措施包括生活方式干预、针灸疗法和营养补充剂。这些干预措施已被报道可缓解超重 PCOS 女性的不孕问题。然而,这些非药物干预措施的效果和安全性存在差异,且临床应用方法尚无标准。因此,有必要进行系统评价和网络荟萃分析(NMA),根据效果对这些非药物干预措施进行排名,并确定哪种方法更适用于临床应用。

方法和分析

我们将从 Cochrane Library、Medline、Embase、PsycINFO、中国知网、万方数据、重庆维普数据库和中国生物医学文献数据库等 8 个数据库中检索自建库以来的所有相关文献,并辅以临床试验注册库和相关参考文献的手工检索。主要结局指标为临床妊娠。活产、排卵、妊娠丢失、多胎妊娠和与干预相关的不良事件将被视为次要结局。STATA 软件 V.15.0 和 Aggregate Data Drug Information System V.1.16.8 将用于进行两两荟萃分析和 NMA。推荐评估、制定与评价系统(Grading of Recommendations Assessment, Development and Evaluation,GRADE)将用于评估证据的确定性。

伦理与传播

由于本研究不包含参与者的原始信息,因此无需获得伦理批准。研究结果将发表在同行评议的期刊上或在相关会议上传播。

前瞻性注册编号

CRD42021283110。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3587/9185587/8f8b41e042c7/bmjopen-2021-059090f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3587/9185587/8f8b41e042c7/bmjopen-2021-059090f01.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3587/9185587/8f8b41e042c7/bmjopen-2021-059090f01.jpg

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