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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LTBI Group | IGRA(+) |
| |
| No LTBI Group | IGRA(+) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | This is a observation study, with no intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| tuberculosis reactivation | tuberculosis during pregnancy period and in 3 months after delivery | 40 weeks after the ET procedure |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ji Qiao, MD. | Reproductive Medicine Centre,Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100191 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34869442 | Derived | 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. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D014376 | Tuberculosis |
| D055985 | Latent Tuberculosis |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
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collect seum sample to detect some inflammatory factors
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000085343 | Latent Infection |