The Effect of Latent Tuberculosis Infection on the Pregnancy Outcome of IVF-ET
2020年6月25日 更新者：Peking University Third Hospital
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
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
研究概览
详细说明
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.
研究类型
观察性的
注册 (预期的)
600
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Beijing
-
Beijing、Beijing、中国、100191
- Peking University Third Hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
有资格学习的性别
女性
取样方法
概率样本
研究人群
Participants were recruited between January 1, 2019, and December 30, 2020, at Peking University Third Hospital, a tertiary referral hospital in Beijing, China.
A board-certified radiologist reviewed CXRs and, if available, chest computed tomography (CT) scans, of women who referred to the reproductive center for IVF-ET.
The patients who had chest imaging abnormalities consistent with old healed TB were admitted or referred to the respiratory clinic and enrolled.
描述
Inclusion Criteria:
- The patients who referred to the reproductive center for IVF-ET
- Chest radiography showed old healed tuberculosis
Exclusion Criteria:
- active tuberculosis
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
LTBI Group
IGRA(+)
|
This is a observation study, with no intervention
|
|
No LTBI Group
IGRA(+)
|
This is a observation study, with no intervention
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
clinical pregnancy rate
大体时间：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.
|
30 days after the ET procedure
|
|
miscarriage rate
大体时间：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.
|
40 weeks after the ET procedure
|
|
live birth rate
大体时间：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.
|
40 weeks after the ET procedure
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
tuberculosis reactivation
大体时间：40 weeks after the ET procedure
|
tuberculosis during pregnancy period and in 3 months after delivery
|
40 weeks after the ET procedure
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ji Qiao, MD.、Reproductive Medicine Centre，Peking University Third Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年1月1日
初级完成 (预期的)
2022年12月30日
研究完成 (预期的)
2022年12月30日
研究注册日期
首次提交
2020年6月21日
首先提交符合 QC 标准的
2020年6月21日
首次发布 (实际的)
2020年6月23日
研究记录更新
最后更新发布 (实际的)
2020年6月29日
上次提交的符合 QC 标准的更新
2020年6月25日
最后验证
2020年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.