To compare the effect of Antetubercular therapy (ATT) in infertile wome
- Conditions
- Health Condition 1: null- Female infertility
- Registration Number
- CTRI/2015/10/006235
- Lead Sponsor
- ICMR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
The inclusion criteria included women who were in the reproductive age group (20-40 years) with primary or secondary infertility and cohabiting with their husbands. Patients with positive endometrial DNA-PCR, with patent tubes on laparoscopy and all other tests (EA-HPE, AFB, Laparoscopy) being negative for genital TB were included in the study. Patients above the age of 40 years with symptoms suggestive of genital TB except infertility and HSG suspicious of genital TB due to extravasation or calcification or genital TB diagnosed on basis of EA-histopathology, AFB smear, hysteroscopy and laparoscopic findings were excluded from the study. Patients were randomized by block randomization into two groups: Group I where patients received ATT for 6 months was given and Group II where patients were not given ATT. A total of 100 infertile women (50 in each group), as per inclusion/exclusion criteria were recruited.
−Age >40 years
−Symptoms suggestive of Genital TB except infertility
−HSG suspicious of genital TB due to extravasation or calcification
−Genital TB diagnosed on basis of EA-histopathology, AFB smear, Bactec culture, hysteroscopy and laparoscopic findings
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The patients in the two groups will be compared for their <br/ ><br>Reproductive outcome (conception during 12 months post laparoscopy) <br/ ><br>Timepoint: 12 months
- Secondary Outcome Measures
Name Time Method PCR negativity after 6 months in two groups(with ATT vs. no ATT)Timepoint: 6 months