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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04443283
Other study ID # PCCMRP
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 30, 2022

Study information

Verified date March 2020
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 600
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- The patients who referred to the reproductive center for IVF-ET

- Chest radiography showed old healed tuberculosis

Exclusion Criteria:

- active tuberculosis

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
This is a observation study, with no intervention

Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary clinical pregnancy rate 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. 30 days after the ET procedure
Primary miscarriage rate 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. 40 weeks after the ET procedure
Primary live birth rate 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. 40 weeks after the ET procedure
Secondary tuberculosis reactivation tuberculosis during pregnancy period and in 3 months after delivery 40 weeks after the ET procedure
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