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To compare the effect of Antetubercular therapy (ATT) in infertile women

ROLE OF ANTITUBERCULAR TREATMENT FOR POSITIVE ENDOMETRIAL ASPIRATE DNA-PCR ON REPRODUCTIVE OUTCOME IN INFERTILE PATIENTS IN INDIAN SETTING-A RANDOMISED TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/10/006235
Enrollment
100
Registered
2015-10-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Female infertility

Interventions

Intervention1: Antitubercular treatment: 2 months INTENSIVE PHASE with Rifampicin (600 mg daily, given orally for 2 months), Isoniazid (300 mg daily, given orally for 2 months), ethambutol (1200 mg d

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: − 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

Design outcomes

Primary

MeasureTime frame
The patients in the two groups will be compared for their Reproductive outcome (conception during 12 months post laparoscopy) Timepoint: 12 months

Secondary

MeasureTime frame
PCR negativity after 6 months in two groups(with ATT vs. no ATT)Timepoint: 6 months

Countries

India

Contacts

Public ContactAlka Kriplani

All India Institute of Medical Sciences, New Delhi

kriplanialka@gmail.com011-26589883

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 11, 2026