The Effect of Latent Tuberculosis Infection on the Pregnancy Outcome of IVF-ET

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Infertility, Tuberculosis

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patients who referred to the reproductive center for IVF-ET Chest radiography showed old healed tuberculosis Exclusion Criteria: active tuberculosis
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LTBI Group<br>IGRA(+) | Other: No intervention<br>* This is a observation study, with no intervention<br>|
| No LTBI Group<br>IGRA(+) | Other: No intervention<br>* This is a observation study, with no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate | 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 | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tuberculosis reactivation | tuberculosis during pregnancy period and in 3 months after delivery | 40 weeks after the ET procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infertility, IVF-ET, old tuberculosis, pregnancy outcome, latent tuberculosis infection