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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04443283

Enrollment

600

Registered

2020-06-23

Start date

2019-01-01

Completion date

2022-12-30

Last updated

2020-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Tuberculosis

Keywords

infertility, IVF-ET, old tuberculosis, pregnancy outcome, latent tuberculosis infection

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.

Interventions

OTHERNo intervention

This is a observation study, with no intervention

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* active tuberculosis

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
tuberculosis reactivation	40 weeks after the ET procedure	tuberculosis during pregnancy period and in 3 months after delivery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026