Status:
UNKNOWN
Short Course Rifapentine and Isoniazid for the Preventive Treatment for Latent Genital Tuberculosis
Lead Sponsor:
Huashan Hospital
Collaborating Sponsors:
Shanghai First Maternity and Infant Hospital
Conditions:
Infertility, Female
Recurrent Implantation Failure
Eligibility:
FEMALE
25-40 years
Phase:
PHASE3
Brief 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 implant...
Detailed Description
The prevalence of latent genital tuberculosis (LGTB) is relatively high in women with infertility and recurrent pregnancy loss. Whether preventive treatment of latent tuberculosis infection (LTBI) can...
Eligibility Criteria
Inclusion
- Women aged 25-40 years old
- Infertile women failed to achieve clinical pregnancy after 4 good quality embryo transfers, with at least 3 fresh or frozen IVF cycles
- Intended to undergo IVF/ICSI
- Ultrasonography or hysterosalpingogram showed a normal uterus cavity, and the thickness of the endometrium was ≥8mm before implantation during last IVF/ICSI cycle
- Patients who voluntarily signed the informed consent and agreed to be followed up as required by the study protocol
Exclusion
- Use of donor eggs/sperm
- An abnormal uterine cavity shown on hysterosalpingogram or hysteroscopy
- Proven tubal infertility
- Proven preimplantation genetic abnormality
- Proven active tuberculosis
- Treated for active tuberculosis or used preventive treatment for LTBI within 2 years
- Being allergic or intolerant of any study drug
- HIV antibody positive and AIDS patients
- 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
- Patients with diabetes mellitus
- Critically ill patients, and according to the judgment of the research physician, it is impossible to survive for more than 16 weeks
- Currently participating in another drug clinical trial
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
1050 Patients enrolled
Trial Details
Trial ID
NCT04528277
Start Date
September 1 2020
End Date
September 1 2022
Last Update
August 27 2020
Active Locations (1)
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1
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, China, 200051