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

Sponsor

Peking University Third Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04443283

Collaborator

(none)

600

Enrollment

Location

47.9

Anticipated Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Infertility Tuberculosis	Other: No intervention

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 Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
LTBI Group IGRA(+)	Other: No intervention This is a observation study, with no intervention
No LTBI Group IGRA(+)	Other: No intervention This is a observation study, with no intervention

Arm

Intervention/Treatment

LTBI Group

IGRA(+)

Other: No intervention

This is a observation study, with no intervention

No LTBI Group

IGRA(+)

Other: No intervention

This is a observation study, with no intervention

Outcome Measures

Primary Outcome Measures

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.
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.