Testosterone does not improve ovarian response in Bologna poor responders: a randomized controlled trial (TESTOPRIM)

Research question: Does testosterone, either in a long or short course, before IVF increase the number of mature oocytes retrieved in poor ovarian response? Design: Single-centre, single-blinded, randomized controlled trial. Poor ovarian response is defined according to Bologna criteria. Sixty-three participants were included and assigned to three arms: group 1 (long testosterone [n = 17]) 12.5 mg/day testosterone gel for 56 days before ovarian stimulation; group 2 (short testosterone [n = 161) 12.5 mg/day testosterone gel for 10 days before ovarian stimulation; and group 3 (control, no intervention). Primary outcome was number of mature oocytes retrieved. Secondary outcomes included other cycle parameters (duration of stimulation, antral follicle count, number of follicles >16 mm, total oocytes retrieved and testosterone levels). Results: The number of mature oocytes retrieved did not differ between the three groups (2.16, 2.71 and 2.91, P = 0.719, groups 1, 2 and 3, respectively). No other significant differences were found in the remaining cycle parameters, except for testosterone levels at the beginning of ovarian stimulation, which were higher in both testosterone groups and relatively higher in group 2 (1.67 and 3.03, respectively versus 0.14 control group, P = 0.01). A Poisson regression model showed no significant differences for the primary outcome (group 3 versus group 2: 0.925, 95% CI 0.572 to 1.508, P = 0.753; group 3 versus group 1: 0.873, 95% CI 0.534 to 1.426, P = 0.587). Conclusions: The use of testosterone, even when applied for a prolonged period, does not improve the number of mature oocytes in poor ovarian response.