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Role of Latent Genital Tuberculosis in Women with Infertility Referred for In Vitro Fertilization: a Prospective Cohort Study

Role of Latent Genital Tuberculosis in Women with Infertility Referred for In Vitro Fertilization: a Prospective Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037063
Enrollment
Unknown
Registered
2020-08-26
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-05

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

Conditions

Recurrent implantation failure

Interventions

LGTB treatment group:1-month regimen of three times weekly rifapentine (150mg per capsule, 450mg po tiw) plus isoniazid (100mg per tablet, 400mg po tiw)
LGTB no treatment group:take no medication related to preventive treatment of tuberculosis
non-LGTB group:take no medication related to preventive treatment of tuberculosis

Sponsors

Shanghai First Maternity and Infant Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Female, age = 25 years old and = 40 years old; 2. Patients with 3 or more failed embryo implantation (or more than 4 high-quality embryos transferred); 3. Patients with IVF / ICSI in accordance with conventional IVF indications, including tubal pelvic factors and male factors; 4. In patients with normal uterine cavity by ultrasound or HSG, the endometrium on the day of previous transplantation was = 8mm; 5. Patients who voluntarily join the study and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. The patients with uterine malformation and intrauterine adhesions had endometrial polyps and hydrosalpinx; 2. The patients with abnormal karyotype were identified; 3. Using donor sperm or egg; 4. Patients with active tuberculosis; 5. In the past two years, patients who have received full course anti tuberculosis treatment due to active tuberculosis, or who have taken rifamycin (rifampicin, rifampicin, etc.) for more than 14 days due to active tuberculosis; 6. Patients who are allergic or intolerant to rifamycin (rifapentine or rifampicin); 7. HIV antibody test positive and AIDS patients; 8. Patients with abnormal liver function: total bilirubin > 2.5 mg / dl (43 umol / L), AST or ALT more than twice the normal upper limit value; 9. Patients who are receiving immunosuppression and biological agents treatment; 10. Patients with diabetes mellitus; 11. There are other serious physical or psychological diseases that are not suitable for the selection.

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy rate;Ongoing Pregnancy Rate;Miscarriage rate;

Secondary

MeasureTime frame
Implantation rate;Incidence of LGTB;ectopic pregnancy rate;Incidence of grade 3 or greater adverse events;Discontinuation of treatment due to side effect of study drugs;Discontinuation of treatment;Completion rate of preventive treatment;Incidence of FGTB;

Countries

china

Contacts

Public ContactXiaoming Teng

Shanghai first maternal and infant health care hospital

tengxiaoming@51mch.com+86 21-54035206

Outcome results

None listed

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