Role of anti-tubercular treatment for positive endometrial aspirate DNA-PCR reproductive outcome in infertile patients in Indian setting - A randomized trial.
The aim of the study was to determine the effect of anti-tubercular therapy (ATT) versus no ATT on reproductive outcome in patients with positive endometrial aspirate DNA-PCR for tuberculosis.



Department of Obstetrics and Gynecology in collaboration with the Department of Microbiology at the All India Institute of Medical Sciences, New Delhi, India.



This prospective randomized study was conducted on 100 women in the reproductive age group with primary or secondary infertility, attending the Gynecology OPD at AIIMS. Women with positive endometrial DNA-PCR, patent tubes on laparoscopy, and all other tests being negative for genital TB were randomized into two groups. In Group 1, patients received ATT for 6 months while in Group 2, patients were not given ATT. In patients who did not conceive a repeat endometrial sampling for DNA-PCR was performed at 6 months and 12 months post-laparoscopy.



It was carried out using Stata 11.0 (College Station, TX, USA).



In Group 1 (ATT), 25 women achieved pregnancy with a pregnancy rate of 50% while in Group 2 (no ATT), 21 women achieved pregnancy with a pregnancy rate of 42% and the difference (95% CI) was 8.0% (-11.5%, 27.5%) which was not statistically significant (p=0.422). Difference (95% CI) in the rate of repeat EA DNA-PCR being positive between the two groups at 6 months was 3.1% (-2.9%, 9.1%), p=0.299, while at the end of 12 months, repeat DNA-PCR remained positive in 23 patients in Group 1 and in 26 patients in Group 2. Difference (95% CI) in the rate of repeat EA DNA-PCR being positive between the two groups at 12 months was 2.3% (-13.0%, 17.7%), p=0.767.



The present study does not validate ATT for positive DNA-PCR; however, it does provide an evidence to stop over-treating patients on the basis of positive EA DNA-PCR even after they have received a 6 months course of ATT. Repeating PCR at 6 months and at 12 months has no role and ATT should not be repeatedly given to the patient on the basis of repeat DNA-PCR alone.



CTRI/2015/10/006235, www.ctri.nic.in.
Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, New Delhi, India.
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Kriplani
Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, New Delhi, India. Electronic address: anupama.bahadur@gmail.com.
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Bahadur
Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, New Delhi, India.
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Kulshrestha
Department of Obstetrics & Gynecology, All India Institute of Medical Sciences, New Delhi, India.
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Agarwal
ICMR, New Delhi, India.
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Singh
Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India.
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Singh
D000328:Adult; D000995:Antitubercular Agents / Q000627:therapeutic use*; D004269:DNA, Bacterial / Q000032:analysis; D004717:Endometrium / Q000382:microbiology*; D005260:Female; D006801:Humans; D007194:India; D007247:Infertility, Female; D009169:Mycobacterium tuberculosis / Q000235:genetics / Q000302:isolation & purification*; D016133:Polymerase Chain Reaction; D011247:Pregnancy; D011256:Pregnancy Outcome; D011446:Prospective Studies; D014384:Tuberculosis, Female Genital / Q000188:drug therapy*; D055815:Young Adult
D000995:Antitubercular Agents; D004269:DNA, Bacterial
Anti-tubercular treatment; Infertility; Pregnancy