NCT04443283

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility
• Tuberculosis

Interventions

Type	Name	Description
OTHER	No intervention	This is a observation study, with no intervention

Timeline

• Start date: 2019-01-01
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2020-06-23
• Last updated: 2020-06-29

Locations

1 site across 1 country: China