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

NCT ID: NCT04443283

Last Updated: 2020-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2022-12-30

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.

Conditions

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Infertility Tuberculosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LTBI Group

IGRA(+)

No intervention

Intervention Type OTHER

This is a observation study, with no intervention

No LTBI Group

IGRA(+)

No intervention

Intervention Type OTHER

This is a observation study, with no intervention

Interventions

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No intervention

This is a observation study, with no intervention

Intervention Type OTHER

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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ji Qiao, MD.

Role: PRINCIPAL_INVESTIGATOR

Reproductive Medicine Centre,Peking University Third Hospital

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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Gai X, Chi H, Zeng L, Cao W, Chen L, Zhang C, Li R, Sun Y, Qiao J. Impact of Positive Interferon-Gamma Release Assay on IVF-ET Pregnancy Outcomes in Infertile Patients With Untreated Prior Tuberculosis: A Prospective Cohort Study. Front Med (Lausanne). 2021 Nov 16;8:749410. doi: 10.3389/fmed.2021.749410. eCollection 2021.

Reference Type DERIVED
PMID: 34869442 (View on PubMed)

Other Identifiers

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PCCMRP

Identifier Type: -

Identifier Source: org_study_id

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