Role of transdermal testosterone gel pre-treatment on IVF outcome: a prospective randomized controlled trial with active control

Background: Dealing with poor ovarian responders is the newest challenge for the present-day reproductive physicians. Androgens are said to increase pregnancy outcomes due to enhanced oocyte retrieval in poor responders. The aim of the study was to measure the effect of transdermal testosterone gel in women with unexplained poor ovarian response.Methods: It was a prospective randomized controlled trial with active control conducted at ART centre, department of obstetrics and gynaecology, AIIMS, New Delhi from August 2017-August 2018. Seventy women with previously failed IVF/ICSI who had ≤5 oocyte retrieval in previous cycle having normal ovarian reserve with normal or low testosterone levels were randomized. Study arm (N=35) received testosterone gel pre-treatment whereas the control arm (N=35) received standard treatment. GnRH antagonist stimulation protocol was followed. The number of oocytes retrieved and pregnancy outcomes were studied.Results: Of the 70 women in the study, the number of oocytes retrieved was significantly higher (6.5±5.8 vs 3.1±2.1; p=0.002), cycle cancellation rate was lower (8.6% vs 22.9%; p=0.094), implantation rate (8.2% vs 2.6%; p=0.228), clinical pregnancy, ongoing pregnancy, live birth rates (14.7% vs 2.9%; p=0.092) and take home baby rates (17.6% vs 2.9%; p=0.049) were higher in testosterone group compared to controls. One woman in testosterone group developed mild OHSS.Conclusions: The study shows that transdermal testosterone gel is found to improve oocyte retrieval significantly in unexpected poor responders, although there was not a significant improvement in pregnancy outcomes. Hence further studies are of utmost importance to establish the effectiveness of the gel.