Status:

UNKNOWN

The Prevalence and Reproductive Outcome of Infertile Women With Genital Tuberculosis

Lead Sponsor:

Huashan Hospital

Collaborating Sponsors:

Shanghai First Maternity and Infant Hospital

General Hospital of Ningxia Medical University

Conditions:

Infertility, Female

Genital Tuberculoses, Female

Eligibility:

FEMALE

20-43 years

Brief Summary

Female genital tuberculosis infection (FGTB) is an important cause of female infertility in TB-endemic areas. The pregnancy rate of assisted reproductive treatment (ART) in the infertile women with FG...

Detailed Description

This project aims to recruit infertile female with high risk of tuberculosis infecton who need assisted reproductive treatment in multiple reproductive centers. The infertility-related medical history...

Eligibility Criteria

Inclusion

  • 1\) Female, aged ≥20 years and \<43 years old;
  • 2\) In line with conventional assisted reproduction indications;
  • 3\) Meet any of the following:
  • with tuberculosis infection history;
  • with a history of close contact to tuberculosis patients;
  • exact positive IGRA results in the past or chest imaging indicated a past history of pulmonary tuberculosis;
  • suspected symptoms of tuberculosis, including fever, night sweats, fatigue, cough and sputum;
  • suspected symptoms of genital tuberculosis, including lower abdominal pain, abnormal menstruation, fallopian tube stenosis, obstruction, thickening, beading changes, uterine cavity adhesions, deformation, pelvic adhesions, etc.;
  • 4\) Voluntarily join the study and sign the informed consent

Exclusion

  • 1\) Co-infection with HIV;
  • 2\) Chromosomal abnormalities;
  • 3\) suspected genital tuberculosis infection symptoms (participants meet inclusion criteria 3)e in Inclusion Criteria) known to be caused only by factors part from tuberculosis, such as endocrine factors, history of ectopic pregnancy, history of uterine curettage, chronic pelvic inflammatory disease, endometriosis, malignant tumors, etc.;
  • 4\) There are other serious physical or mental illnesses that are not suitable for selection;
  • 5\) Participate in other clinical studies that would affect this study at the same time.

Key Trial Info

Start Date :

December 1 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

August 1 2023

Estimated Enrollment :

3000 Patients enrolled

Trial Details

Trial ID

NCT05311423

Start Date

December 1 2021

End Date

August 1 2023

Last Update

April 5 2022

Active Locations (1)

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Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, China, 200051