Short Course Rifapentine and Isoniazid for the Preventive Treatment for Latent Genital Tuberculosis

• Status: Not yet recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to assess the efficacy, safety and tolerability of the 1-month regimen of three times weekly rifapentine plus isoniazid in improving fertility outcome in recurrent implantation failure (RIF) patients with latent genital tuberculosis (LGTB), compared to no treatment and non-LGTB patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huashan Hospital
• Collaborator: Shanghai First Maternity and Infant Hospital
• Treatments: Isoniazid; Rifapentine

Criteria

Inclusion Criteria:

1. Women aged 25-40 years old

2. Infertile women failed to achieve clinical pregnancy after 4 good quality embryo transfers, with at least 3 fresh or frozen IVF cycles

3. Intended to undergo IVF/ICSI

4. Ultrasonography or hysterosalpingogram showed a normal uterus cavity, and the thickness of the endometrium was ≥8mm before implantation during last IVF/ICSI cycle

5. Patients who voluntarily signed the informed consent and agreed to be followed up as required by the study protocol

Exclusion Criteria:

1. Use of donor eggs/sperm

2. An abnormal uterine cavity shown on hysterosalpingogram or hysteroscopy

3. Proven tubal infertility

4. Proven preimplantation genetic abnormality

5. Proven active tuberculosis

6. Treated for active tuberculosis or used preventive treatment for LTBI within 2 years

7. Being allergic or intolerant of any study drug

8. HIV antibody positive and AIDS patients

9. Patients with impaired liver function: hepatic encephalopathy, ascites; total bilirubin is more than 2 times higher than the upper limit of normal; alanine transaminase (ALT) or aspartate aminotransferase (AST) is more than 5 times the upper limit of normal

10. Patients with diabetes mellitus

11. Critically ill patients, and according to the judgment of the research physician, it is impossible to survive for more than 16 weeks

12. Currently participating in another drug clinical trial