Gai Xiaoyan, Chi Hongbin, Zeng Lin, Cao Wenli, Chen Lixue, Zhang Chen, Li Rong, Sun Yongchang, Qiao Jie
Department of Respiratory and Critical Care Medicine, Peking University Third Hospital, Beijing, China.
Center of Reproductive Medicine, Peking University Third Hospital, Beijing, China.
Front Med (Lausanne). 2021 Nov 16;8:749410. doi: 10.3389/fmed.2021.749410. eCollection 2021.
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 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. 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. 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. ClinicalTrials.gov; identifier: NCT04443283.
结核病（TB）是一种严重危害人类健康和女性生殖的主要传染病。在我们之前的研究中，通过胸部X线（CXR）筛查发现，准备进行体外受精-胚胎移植（IVF-ET）的不孕患者中有10.4%既往有肺结核（PTB）。其中，81.8%未接受抗结核治疗。既往未经治疗的PTB不孕女性是否存在潜伏性结核感染（LTBI）以及LTBI是否影响IVF-ET结局仍不清楚。在本研究中，我们旨在分析既往未经治疗的PTB患者中LTBI与IVF-ET后妊娠结局之间的关系。我们设计了一项前瞻性队列研究，纳入1200名CXR结果提示有陈旧性未治愈结核且准备进行IVF-ET的不孕女性。有活动性结核病史和抗结核治疗史的患者将被排除。对于CXR结果提示有陈旧性未治愈结核的患者，将使用干扰素-γ释放试验（IGRA）来构建IGRA阳性和IGRA阴性患者队列。参与者将接受IVF-ET。记录一般信息，包括年龄、体重指数、不孕原因和控制性卵巢过度刺激方案。参与者将在孕期接受随访。主要结局是活产。次要结局包括获卵数、优质胚胎率、临床妊娠、孕期活动性结核病例数和流产。本研究已获得北京大学第三医院伦理委员会批准[批准文号（2020）218-01；批准日期：2020年6月19日]。研究结果将通过科学/医学会议进行传播，并发表在学术期刊上。ClinicalTrials.gov标识符：NCT04443283。
