latent tuberculosis infection
Conditions
Interventions
Experimental group:anti-tuberculosis treatment
Isoniazid: The dose is 15 mg/kg, rounded up to the nearest 50/100 mg, the maximum dose is 900 mg.
Rifapentine: 32.1-49.9 kg body weight, 750 mg
Above 50.0 kg, the maximum dose is 900 mg.
The frequency of medication was once a week. Continuous use for 3 months. After 3 months, the embryo transfer cycle was started.
Control group:Use placebo. Placebo was designed to look similar to isoniazid and rifapentine and to be used in the same dosage
Sponsors
the Sixth Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with latent tuberculosis infection based on WHO guideline, published in 2020: No symptoms or physical findings suggestive of TB disease; Positive TB blood test or TST result (A reaction of >= 10 mm of induration is considered positive); (TST results should only be read by a trained health care professional) Normal chest radiograph; 2. BMI between 18-28 kg/m² ; 3. Normal ovarian reserve function: Anti-Müllerian Hormone (AMH) > 1.2 ng/ml, Follicle-Stimulating Hormone (FSH) <= 10 IU/L on menstrual cycle days 2-4, and Luteinizing Hormone (LH), Estradiol (E2), Testosterone (T), and Prolactin (PRL) within the laboratory's normal range, or considered clinically insignificant by the investigator; 4. Women aged 20 to 40 years with indications for IVF-ET/ICSI assisted reproductive treatment; 5. First IVF/ICSI cycle; 6. The subject and her partner voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Low ovarian reserve, indicated by at least one of the following: bilateral ovarian AFC = 70 mm). 3.History or gynecological ultrasound suggesting any of the following conditions with clinical significance: uterine and endometrial abnormalities, including submucosal fibroids, intramural fibroids larger than 4 cm or smaller than 4 cm but affecting uterine cavity shape, endometrial polyps >= 1 cm, intrauterine adhesions evaluated by the researcher as affecting pregnancy, and uterine malformations; ovarian and adnexal abnormalities: such as complex ovarian cysts with a diameter > 3.5 cm, inability to retrieve eggs from one or both ovaries, untreated unilateral or bilateral hydrosalpinx evaluated by the researcher as affecting pregnancy, etc. 4. HIV antibody positive or syphilis spirochete positive. 5. Any disease or condition that could affect the function of body systems and might impact the absorption, excessive accumulation, metabolism, or excretion of the investigational drug (e.g., chronic intestinal diseases, Crohn's disease, ulcerative colitis). 6. Liver and kidney dysfunction diseases. 7. Allergy or contraindication to ovulation induction drugs and anti-tuberculosis drugs. 8. The subject or their partner, or both, carry chromosomal structural abnormalities deemed clinically significant by the researcher, or have hereditary diseases requiring preimplantation genetic testing. 9. Participation in other clinical trials within 3 months prior to the screening period. 10. Other reasons considered unsuitable for participation in this study by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth rate after the first transplantation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of oocyte retrival;Number of 2pn fertilization ;2pn fertilization rate;Top quality embyro rate;HCG positive rate;Clinical pregnancy rate;On-goning pregnancy rate; | — |
Countries
China
Contacts
Public ContactXiaoyan Liang
The Sixth Affiliated Hospital of Sun Yan-Sen University
Outcome results
None listed