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Research on the role of reproductive tract microbiota in immune regulation and infertility related to pelvic tuberculosis in women of childbearing age

Research on the role of reproductive tract microbiota in immune regulation and infertility related to pelvic tuberculosis in women of childbearing age

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400083764
Enrollment
Unknown
Registered
2024-04-30
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Interventions

Control group:None
Experimental group:None

Sponsors

The Third People's Hospital of Shenzhen
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: ? Experimental group: A. Participants aged 20-40 years; B. Initially diagnosed with female genital tuberculosis (FGTB) based on the criteria outlined in "Obstetrics and Gynecology" (9th edition, People's Medical Publishing House), considering clinical symptoms, signs, and epidemiological history (including primary infertility, sparse or absent menstruation, low-grade fever, night sweats, pelvic inflammatory disease or ascites, previous contact with tuberculosis or personal history of tuberculosis infection such as pleurisy or intestinal tuberculosis). Additionally, a positive result in any of the following tests can confirm FGTB diagnosis: a) detection of acid-fast bacilli in sputum smear or positive culture for Mycobacterium tuberculosis; b) positive GeneXpert test from endometrial or ovarian biopsy samples; c) positive PCR test combined with histopathological examination revealing typical tuberculous nodules in endometrium, fallopian tube, ovary or cervix along with uterine fallopian tube X-ray imaging for confirmation; C. No anti-tuberculosis treatment initiated. Control group: A. Participants aged 20-40 years; B. Underwent physical examination to exclude latent tuberculosis infection. ?Within 1 month, no vaginal preparations have been used; within 1 week, no cervical treatment, endometrial biopsy, intrauterine device removal or hysteroscopy has been performed; within 5 days, no vaginal irrigation has been done; and within 48 hours, no sexual intercourse has occurred; ?None of the individuals were in pregnancy or lactation, and there was no history of infertility diagnosis; ?Patients have complete clinical and pathological data, including age, body mass index (BMI), menstrual history, reproductive history, tuberculosis history, and place of residence.

Exclusion criteria

Exclusion criteria: ?Non-compliance with the current research; ?The individual has tested positive for Human Immunodeficiency Virus (HIV); ?Patients who have participated in other clinical trials of medications within the past 3 months; ?Patients with other diseases affecting the reproductive tract microbiota; ?Patients who have received antibiotic treatment within 2 months; ?Patients suffering from severe conditions such as cardiovascular, hepatic, renal disorders and others; ?Pregnant women or individuals who are planning to conceive; ?The integration of diabetes with immune-related diseases; ?Long-term use of inhibitors may lead to the use of systemic hormonal or immunotherapy.

Design outcomes

Primary

MeasureTime frame
Composition of vaginal microbiota;Proportions of T cell subsets, regulatory T cells, and monocyte subsets;Levels of cytokines in the serum;Reproductive tract microecosystem;

Countries

China

Contacts

Public ContactShuihua Lu

The Third People's Hospital of Shenzhen

lushuihua66@126.com+86 189 3081 1818

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026