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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1
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, China, 200051