Clinical trial NCT04443283: The Effect of Latent Tuberculosis Infection on the Pregnancy Outcome of IVF-ET
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Tuberculosis
Keywords: infertility
IVF-ET
old tuberculosis
pregnancy outcome
latent tuberculosis infection
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants were recruited between January 1, 2019, and December 30, 2020, at Peking University Third Hospital, a tertiary referral hospital in Beijing, China. A board-certified radiologist reviewed CXRs and, if available, chest computed tomography (CT) scans, of women who referred to the reproductive center for IVF-ET. The patients who had chest imaging abnormalities consistent with old healed TB were admitted or referred to the respiratory clinic and enrolled.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* active tuberculosis

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 30 days after the ET procedure
measure: miscarriage rate
timeFrame: 40 weeks after the ET procedure
measure: live birth rate
timeFrame: 40 weeks after the ET procedure
Secondary outcomes:
measure: tuberculosis reactivation
timeFrame: 40 weeks after the ET procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Reproductive Medicine Centre，Peking University Third Hospital
name: Ji Qiao, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.