LISBON – Pretreatment with transdermal testosterone failed to improve outcomes in women with poor ovarian response who were undergoing intra-cytoplasmic sperm injection in a randomized clinical study.
The primary endpoint, number of cumulus-oocyte complexes (COCs) retrieved, was not significantly different with testosterone gel 10 mg applied to the thigh for 21 days before ovarian stimulation versus no pretreatment (median, 3.5 vs. 3.0; P = .91).
Further, no differences were observed in fertilization rates (66.7% vs. 66.7%; P = .97) or live birth rates per intention-to-treat analysis (7.7% vs. 8.3%; 95% confidence interval, –19.0 to +16.9).
Patrice Wendling/Frontline Medical News
Dr. Julia Bosdou
“An improvement in {in vitro fertilization] outcome cannot be excluded using a larger dose of testosterone more than 10 mg or a pretreatment period longer than 21 days,” study author Dr. Julia Bosdou said at the annual meeting of the European Society of Human Reproduction and Embryology.
Because of sample size restrictions, no conclusions can be drawn regarding the probability of live birth, she added.
The study was designed to detect a difference of 1.5 COCs retrieved with a sample size of 42 patients. In all, 50 women who fulfilled the Bologna criteria for poor ovarian response were allocated to the testosterone group (n = 26) or control group (n = 24). All patients underwent a long follicular gonadotropin-releasing hormone agonist (GnRHa) protocol. Recombinant follicle-stimulating hormone (FSH) 300 IU daily was started on day 22 following GnRHa initiation.
The testosterone dose was based on published data showing a beneficial effect with a 21-day duration, said Dr. Bosdou of the Aristotle University of Thessaloniki (Greece).
Androgens have been suggested to play a critical role in early follicular development by enhancing ovarian sensitivity to FSH. A recent meta-analysis by the investigators of the current study also showed that pretreatment with transdermal testosterone increased clinical pregnancy and live birth rates in poor responders, but it was based on only two randomized trials (Hum. Reprod. Update 2012;18:127-45), she observed.
As expected, testosterone levels in the current study were significantly higher in the testosterone group than the control group on day 22 (median, 114 ng/dL vs. 20 ng/dL; P < .001). Duration of FSH stimulation was comparable between groups (12.5 days vs. 12 days; P = .48), Dr. Bosdou said.
Endometrial thickness on the day of human chorionic gonadotropin administration was significantly greater with testosterone pretreatment (median, 10.7 mm vs. 9 mm; P = .03).
No adverse events were reported in either group, she said.
The study was partially funded by a scholarship award to Dr. Bosdou from the Academy of Athens. Dr. Bosdou reported having no conflicts of interest.
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