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

• Conditions: Infertility; Tuberculosis
• Interventions: Other: No intervention

• Registration Number: NCT04443283
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2020-03
• Study First Submitted: 2020-06-21
• Study First Submitted QC: 2020-06-21
• Study First Posted: 2020-06-23
• Last Update Submitted: 2020-06-25
• Last Update Posted: 2020-06-29
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

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

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Exclusion Criteria

• active tuberculosis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No LTBI Group	No intervention	IGRA(+)
LTBI Group	No intervention	IGRA(+)

Primary Outcome Measures

Name	Time	Method
miscarriage rate	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	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	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.

Secondary Outcome Measures

Name	Time	Method
tuberculosis reactivation	40 weeks after the ET procedure	tuberculosis during pregnancy period and in 3 months after delivery

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China