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

NCT04443283 | Unknown

• 1 other identifier: PCCMRP
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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

Conditions

Infertility; Tuberculosis

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• tuberculosis reactivation

  40 weeks after the ET procedure

Study Arms (2)

LTBI Group

IGRA(+)

Other: No intervention

No LTBI Group

IGRA(+)

Other: No intervention

Interventions

No intervention OTHER

This is a observation study, with no intervention

LTBI Group; No LTBI Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• active tuberculosis

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (1)

• 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.

  PMID: 34869442 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

collect seum sample to detect some inflammatory factors

MeSH Terms

Conditions

Infertility; Tuberculosis; Latent Tuberculosis

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Ji Qiao, MD.

  Reproductive Medicine Centre，Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2020
• First Posted: June 23, 2020
• Study Start: January 1, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: June 29, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)