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

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

doi:10.1016/j.heliyon.2023.e13838

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

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

Authors

Maryam Ghorbani¹, Fatemeh Sadat Hoseini², Masud Yunesian³, Shahrbanoo Salehin⁴, Seyedeh Solmaz Talebi⁵, Afsaneh Keramat⁶

Affiliations

¹ Student Research Committee, School of Nursing and Midwifery, Shahroud University of Medical Sciences, Shahroud, Iran.
² Faculty Member of School of Medicine, Golestan University of Medical Sciences, Gorgan, Iran.
³ School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.
⁴ Sexual Health and Fertility Research center. Shahroud University of Medical sciences. Shahroud. Iran.
⁵ Department of Epidemiology, School of Public Health, Shahroud University of Medical Sciences, Shahroud, Iran.
⁶ Center for Health Related Social and Behavioral Sciences Research, Shahroud University of Medical Sciences, Shahroud, Iran.

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.

Keywords: Dropout; Infertility; Intervention; Randomized clinical trial.