Impact of Positive Interferon-Gamma Release Assay on IVF-ET Pregnancy Outcomes in Infertile Patients With Untreated Prior Tuberculosis: A Prospective Cohort Study

Introduction: Tuberculosis (TB) is a major infectious disease that seriously endangers human health and female reproduction. In our previous study, 10.4% of infertile patients preparing for In vitro fertilization and embryo transfer (IVF-ET) had prior pulmonary TB (PTB) as detected on chest X-ray (C...

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Autores principales: Xiaoyan Gai, Hongbin Chi, Lin Zeng, Wenli Cao, Lixue Chen, Chen Zhang, Rong Li, Yongchang Sun, Jie Qiao
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Publicado: Frontiers Media S.A. 2021
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spelling oai:doaj.org-article:cd33a8bb955e4b7594e9c51d5cc34b6e2021-11-16T04:44:51ZImpact of Positive Interferon-Gamma Release Assay on IVF-ET Pregnancy Outcomes in Infertile Patients With Untreated Prior Tuberculosis: A Prospective Cohort Study2296-858X10.3389/fmed.2021.749410https://doaj.org/article/cd33a8bb955e4b7594e9c51d5cc34b6e2021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fmed.2021.749410/fullhttps://doaj.org/toc/2296-858XIntroduction: Tuberculosis (TB) is a major infectious disease that seriously endangers human health and female reproduction. In our previous study, 10.4% of infertile patients preparing for In vitro fertilization and embryo transfer (IVF-ET) had prior pulmonary TB (PTB) as detected on chest X-ray (CXR) screening. Among them, 81.8% did not receive anti-TB treatment. It remains unclear whether infertile women with untreated prior PTB have latent TB infection (LTBI) and whether LTBI affects IVF-ET outcomes. In this study, we aim to analyze the relationship between LTBI and pregnancy outcomes following IVF-ET in patients with untreated prior PTB.Methods and Analysis: We designed a prospective cohort study of 1,200 infertile women with CXR findings suggestive of old-healed untreated TB, who are preparing for IVF-ET. Patients with a history of active TB and anti-TB treatment will be excluded. Interferon-gamma release assay (IGRA) will be used in patients with CXR findings suggestive of old-healed untreated TB to construct a cohort of IGRA-positive and IGRA-negative patients. Participants will undergo IVF-ET. General information, including age, body mass index, infertility causes, and controlled ovarian hyperstimulation protocol, will be recorded. Participants will be followed up during pregnancy. The primary outcome is live birth. Secondary outcomes include the numbers of retrieved oocytes, high-quality embryo rate, clinical pregnancy, number of active TB cases during pregnancy, and miscarriage.Ethics and Dissemination: The study was approved by the Ethics Committee of Peking University Third Hospital [approval number (2020)218-01; approval date: June 19, 2020]. The research results will be disseminated through scientific/medical conferences and published in academic journals.Trial Registration:ClinicalTrials.gov; identifier: NCT04443283.Xiaoyan GaiHongbin ChiLin ZengWenli CaoLixue ChenChen ZhangRong LiYongchang SunJie QiaoFrontiers Media S.A.articleinterferon-gamma release assaytuberculosisIVF-ETpregnancy outcomeinfertilityMedicine (General)R5-920ENFrontiers in Medicine, Vol 8 (2021)
institution DOAJ
collection DOAJ
language EN
topic interferon-gamma release assay
tuberculosis
IVF-ET
pregnancy outcome
infertility
Medicine (General)
R5-920
spellingShingle interferon-gamma release assay
tuberculosis
IVF-ET
pregnancy outcome
infertility
Medicine (General)
R5-920
Xiaoyan Gai
Hongbin Chi
Lin Zeng
Wenli Cao
Lixue Chen
Chen Zhang
Rong Li
Yongchang Sun
Jie Qiao
Impact of Positive Interferon-Gamma Release Assay on IVF-ET Pregnancy Outcomes in Infertile Patients With Untreated Prior Tuberculosis: A Prospective Cohort Study
description Introduction: Tuberculosis (TB) is a major infectious disease that seriously endangers human health and female reproduction. In our previous study, 10.4% of infertile patients preparing for In vitro fertilization and embryo transfer (IVF-ET) had prior pulmonary TB (PTB) as detected on chest X-ray (CXR) screening. Among them, 81.8% did not receive anti-TB treatment. It remains unclear whether infertile women with untreated prior PTB have latent TB infection (LTBI) and whether LTBI affects IVF-ET outcomes. In this study, we aim to analyze the relationship between LTBI and pregnancy outcomes following IVF-ET in patients with untreated prior PTB.Methods and Analysis: We designed a prospective cohort study of 1,200 infertile women with CXR findings suggestive of old-healed untreated TB, who are preparing for IVF-ET. Patients with a history of active TB and anti-TB treatment will be excluded. Interferon-gamma release assay (IGRA) will be used in patients with CXR findings suggestive of old-healed untreated TB to construct a cohort of IGRA-positive and IGRA-negative patients. Participants will undergo IVF-ET. General information, including age, body mass index, infertility causes, and controlled ovarian hyperstimulation protocol, will be recorded. Participants will be followed up during pregnancy. The primary outcome is live birth. Secondary outcomes include the numbers of retrieved oocytes, high-quality embryo rate, clinical pregnancy, number of active TB cases during pregnancy, and miscarriage.Ethics and Dissemination: The study was approved by the Ethics Committee of Peking University Third Hospital [approval number (2020)218-01; approval date: June 19, 2020]. The research results will be disseminated through scientific/medical conferences and published in academic journals.Trial Registration:ClinicalTrials.gov; identifier: NCT04443283.
format article
author Xiaoyan Gai
Hongbin Chi
Lin Zeng
Wenli Cao
Lixue Chen
Chen Zhang
Rong Li
Yongchang Sun
Jie Qiao
author_facet Xiaoyan Gai
Hongbin Chi
Lin Zeng
Wenli Cao
Lixue Chen
Chen Zhang
Rong Li
Yongchang Sun
Jie Qiao
author_sort Xiaoyan Gai
title Impact of Positive Interferon-Gamma Release Assay on IVF-ET Pregnancy Outcomes in Infertile Patients With Untreated Prior Tuberculosis: A Prospective Cohort Study
title_short Impact of Positive Interferon-Gamma Release Assay on IVF-ET Pregnancy Outcomes in Infertile Patients With Untreated Prior Tuberculosis: A Prospective Cohort Study
title_full Impact of Positive Interferon-Gamma Release Assay on IVF-ET Pregnancy Outcomes in Infertile Patients With Untreated Prior Tuberculosis: A Prospective Cohort Study
title_fullStr Impact of Positive Interferon-Gamma Release Assay on IVF-ET Pregnancy Outcomes in Infertile Patients With Untreated Prior Tuberculosis: A Prospective Cohort Study
title_full_unstemmed Impact of Positive Interferon-Gamma Release Assay on IVF-ET Pregnancy Outcomes in Infertile Patients With Untreated Prior Tuberculosis: A Prospective Cohort Study
title_sort impact of positive interferon-gamma release assay on ivf-et pregnancy outcomes in infertile patients with untreated prior tuberculosis: a prospective cohort study
publisher Frontiers Media S.A.
publishDate 2021
url https://doaj.org/article/cd33a8bb955e4b7594e9c51d5cc34b6e
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