The Prevalence and Reproductive Outcome of Infertile Women With Genital Tuberculosis
TB-PRIME
The Prevalence of Genital Tuberculosis and the Impact on Reproductive Outcomes in Infertile Women: a National Multicenter Prospective Cohort Study
1 other identifier
observational
3,000
1 country
1
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 FGTB is still unsatisfied even after receiving standard anti-tuberculosis treatment. Moreover, recent years have witnessed an alarming increase in reports of FGTB-related maternal and neonatal complications after fertility treatments. These underscore that timely detection and treatment of FGTB before ART hold benefit for the mother and child.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2021
CompletedFirst Submitted
Initial submission to the registry
January 21, 2022
CompletedFirst Posted
Study publicly available on registry
April 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedApril 5, 2022
March 1, 2022
1.5 years
January 21, 2022
March 27, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Clinical pregnancy rate of ART
the number of participants with gestational sacs seen by ultrasound examination 4-6 weeks after transplantation/the number of embryo transfer cycles in this group
2 years
Continued pregnancy rate of ART
the number of patients whose pregnancy was confirmed by repeat ultrasonography at 10th week of gestation/the number of embryo transfer cycles in this group
2 years
Prevalence of SGTB among infertile women
the number of SGTB participants/the total number of this project
6 months
Secondary Outcomes (12)
Prevalence of FGTB/LTBI among infertile women
2 years
Abortion rate
2 years
Ectopic pregnancy rate
2 years
Preterm birth rate
2 years
Live birth rate
2 years
- +7 more secondary outcomes
Study Arms (4)
Non-TB Group
QuantiFERON-TB test (QFT) negative, continue assisted reproductive treatment
Latent tuberculosis infection Group
QFT positive. Excluded active pulmonary tuberculosis, patients have negative endometrial histopathology, acid-fast bacilli (AFB) microscopy, Mycobacterium tuberculosis (Mtb) culture, or GeneXpert MTB/RIF Ultra test results. Then assisted reproductive treatment can be continued, but follow-up for tuberculosis-related symptoms is required
Subclinical genital tuberculosis Group
QFT positive. Excluded active pulmonary tuberculosis, patients have negative endometrial histopathology, AFB microscopy, Mtb culture, but GeneXpert MTB/RIF Ultra positive test results. They are recommended to receive 6-month first-line standard anti-tuberculosis treatment (ATT) regimen
Female genital tuberculosis Group
QFT positive. Excluded active pulmonary tuberculosis, regardless of GeneXpert MTB/RIF Ultra results, at least one of these test results, including endometrial histopathologiy, AFB microscopy, Mtb culture is positive, they will receive 6-month ATT
Interventions
Endometrial biopsy is required to diagnose LTBI, SGTB and FGTB, which is an invasive operation and increases patients' economic burden. A screening method has been established that uses the interferon gamma release test as the primary screening test, and those who are positive undergo endometrial biopsy. Therefore, this project will use QFT to screen participants with Mtb infection, and further endometrium biopsy will be performed for QFT positive patients to diagnose LTBI, FGTB and SGTB. For participants with negative results for all diagnostic tests but QFT (defined as LTBI), close follow-up is necessary according to WHO guidelines.
Eligibility Criteria
Infertile female patients with high risk factors for tuberculosis infection who intend to undergo assisted reproduction
You may qualify if:
- \) Female, aged ≥20 years and \<43 years old;
- \) In line with conventional assisted reproduction indications;
- \) 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.;
- \) Voluntarily join the study and sign the informed consent
You may not qualify if:
- \) Co-infection with HIV;
- \) Chromosomal abnormalities;
- \) There are other serious physical or mental illnesses that are not suitable for selection;
- \) Participate in other clinical studies that would affect this study at the same time.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huashan Hospitallead
- Shanghai First Maternity and Infant Hospitalcollaborator
- General Hospital of Ningxia Medical Universitycollaborator
- Tang-Du Hospitalcollaborator
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical Schoolcollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
- The 924th Hospital of Joint Logistics Support Force of Chinese People's Liberationcollaborator
- Shenzhen Zhongshan Urology Hospitacollaborator
- Northwest Women's and Children's Hospital, Xi'an, Shaanxicollaborator
- Jiangxi Maternal and Child Health Hospitalcollaborator
- The First People's Hospital of Yunnancollaborator
- Tongji Hospitalcollaborator
- The Second Hospital of Hebei Medical Universitycollaborator
- First Affiliated Hospital of Wenzhou Medical Universitycollaborator
Study Sites (1)
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, 200051, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 18 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- director of department of infectious diseases
Study Record Dates
First Submitted
January 21, 2022
First Posted
April 5, 2022
Study Start
December 1, 2021
Primary Completion
June 1, 2023
Study Completion
August 1, 2023
Last Updated
April 5, 2022
Record last verified: 2022-03