Role of anti-tubercular treatment for positive endometrial aspirate DNA-PCR reproductive outcome in infertile patients in Indian setting – A randomized trial

Abstract

AimsThe 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. Settings and designDepartment of Obstetrics and Gynecology in collaboration with the Department of Microbiology at the All India Institute of Medical Sciences, New Delhi, India. Methods and materialsThis 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. Statistical analysisIt was carried out using Stata 11.0 (College Station, TX, USA). ResultsIn 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. ConclusionThe 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. Clinical trial registration numberCTRI/2015/10/006235, www.ctri.nic.in.