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一项针对有辅助生殖技术周期失败后不孕治疗中断史的伊朗不孕女性的支持性随机临床试验:研究方案。

A supportive randomized clinical trial on Iranian infertile women with the history of infertility treatments dropout following unsuccessful ART cycle/s: A study protocol.

作者信息

Ghorbani Maryam, Hoseini Fatemeh Sadat, Yunesian Masud, Salehin Shahrbanoo, Talebi Seyedeh Solmaz, Keramat Afsaneh

机构信息

Student Research Committee, School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran.

Faculty Member of School of Medicine, Golestan University of Medical Sciences, Gorgan, Iran.

出版信息

Heliyon. 2023 Feb 17;9(3):e13838. doi: 10.1016/j.heliyon.2023.e13838. eCollection 2023 Mar.

DOI:10.1016/j.heliyon.2023.e13838
PMID:36879964
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9984792/
Abstract

INTRODUCTION

Due to high dropout rate of infertility treatments and lack of any intervention for motivating infertile couples to continue treatments, the present study will be conducted with the aim of designing, implementing and determining the effectiveness of the proposed intervention in order to continue infertility treatments.

METHODS

& Analysis: We will conduct this study in two stages; a review of literature and past studies will be done to identify interventions that have been performed for infertile couples, and then an appropriate intervention with the aim of continuing infertility treatments for infertile women will be designed. After that a Delphi study will be designed in accordance with collected information of previous stages and will be approved by experts In the second stage we will implement designed intervention of a randomized clinical trial on two groups of infertile women (control and intervention) with the history of infertility treatment dropout following unsuccessful cycle. We will use descriptive statistic in first and second stage. In second stage Chi square test and independent samples T test will be used to compare variables between groups and variables in study questionnaires before and after the intervention between two groups of study.

DISCUSSION

The present study will be the first study to be performed as a clinical trial on infertile women who have discontinued the treatments, with the aim of continuing treatments. Thereupon, it seems that the results of this study will be the basis for studies around the world to prevent premature cessation of infertility treatments.

摘要

引言

由于不孕症治疗的高辍学率以及缺乏任何激励不孕夫妇继续治疗的干预措施,本研究将以设计、实施并确定所提议干预措施以继续不孕症治疗的有效性为目的而开展。

方法与分析

我们将分两个阶段进行本研究;首先对文献和过往研究进行回顾,以确定已对不孕夫妇实施的干预措施,然后设计一项旨在让不孕女性继续接受不孕症治疗的适当干预措施。之后,将根据前几个阶段收集的信息设计一项德尔菲研究,并由专家批准。在第二阶段,我们将对两组有不孕症治疗失败后辍史的不孕女性(对照组和干预组)实施设计好的随机临床试验干预措施。在第一阶段和第二阶段我们将使用描述性统计方法。在第二阶段,将使用卡方检验和独立样本t检验来比较两组之间的变量以及两组研究对象在干预前后研究问卷中的变量。

讨论

本研究将是第一项针对已停止治疗的不孕女性开展的旨在继续治疗的临床试验研究。因此,本研究的结果似乎将成为全球防止过早停止不孕症治疗研究的基础。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/425b/9984792/c57f6e5c04fd/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/425b/9984792/c57f6e5c04fd/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/425b/9984792/c57f6e5c04fd/gr1.jpg

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