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临床试验/NCT04443283
NCT04443283Unknown不适用

A Prospective Cohort Study on the Effect of Latent Infection of Tuberculosis on the Pregnancy Outcome of IVF-ET in Infertile Patients With Radiographic Lesions Suggesting Old Healed Tuberculosis

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
600
试验地点
1
主要终点
miscarriage rate

研究概览

简要总结

This study evaluate the effect of latent infection of tuberculosis on the pregnancy outcome of IVF-ET in infertile patients with radiographic lesions suggesting old healed tuberculosis

详细描述

China is one of the countries with high burden of tuberculosis (TB) defined by WHO. IVF-ET is an effective method to treat infertility. Chest X-ray is a routine examination before IVF-ET, which can exclude active tuberculosis. However, for patients with chest X-ray showing old healed tuberculosis, the relationship between latent tuberculosis infection (LTBI) and pregnancy outcomes is unknown. In this study, a prospective cohort study was carried out in infertile women who were planning to receive IVF-ET. IGRA were tested in patients with old tuberculosis in chest X-ray. A cohort of IGRA positive and IGRA negative was constructed. The pregnancy outcomes were followed up prospectively and the relationship between latent infection of tuberculosis and pregnancy outcomes was analyzed. The primary outcome was clinical pregnancy rate, miscarriage rate and live birth rate. Secondary outcomes were tuberculosis reactivation during pregnancy period and in 3 months after delivery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • The patients who referred to the reproductive center for IVF-ET
  • Chest radiography showed old healed tuberculosis

排除标准

  • active tuberculosis

结局指标

主要结局

miscarriage rate

时间窗: 40 weeks after the ET procedure

Miscarriage was defined as a pregnancy loss before 28 weeks of gestation (calculated among women who became pregnant). The miscarriage rate was defined as miscarriages per clinical pregnancy.

live birth rate

时间窗: 40 weeks after the ET procedure

Live birth was defined as delivery of a living foetus (or living foetuses) beyond 28 weeks of gestation. The live birth rate was defined as live birth per embryo transfer.

clinical pregnancy rate

时间窗: 30 days after the ET procedure

Clinical pregnancy was defined as the observation of a gestational sac on ultrasonography. The clinical pregnancy rate was defined as clinical pregnancy per embryo transfer.

次要结局

  • tuberculosis reactivation(40 weeks after the ET procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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