Randomized, Placebo-Controlled Clinical Trial of Transdermal dihydrotestosterone Gel to Improve In Vitro Fertilization Outcomes In Women With Poor Ovarian Response

Despite the advances in assisted reproduction techniques, suboptimal In Vitro Fertilization(IVF) outcomes in women with Poor Ovarian Response(POR) still remains a challenge. Older women seeking IVF have suboptimal utcomes, at least partly due to inadequate number of eggs on conventional stimulation. This suboptimal response relates mainly to inadequate ovarian response but there is often also reduced live birth rates, increased risk cycle cancellation and a need larger doses of gonadotrophins, which increases both cost and risk of ovarian hyperstimulation syndrome (OHSS) risk. There is now growing evidence that androgens (or male hormones) may improve egg quality and numbers in women with POR. So far the androgens used in women with POR include testosterone and the pro-androgen hormone Dehydroepiandrosterone(DHEA) as well as aromatase inhibitor drugs, which increase the body’s own testosterone levels by blocking its conversion to estradiol. For each of these drugs, their multiple levels of action mean that it is not clear whether they produce any benefits by acting as an androgen (or male hormone). For this reason, this study is using dihydrotestosterone (DHT), the natural product of testosterone in the body of men and women, and which acts only as a pure androgen in the body. As a result, the study will determine for the first time whether these drugs do work as androgens or not and may refine and improve the treatment for POR. In this study we will temporarily increase the circulating levels of DHT during the time when oocyte (egg) development and maturation is occurring. This will be achieved by applying the DHT gel onto the skin once a day for 21 days prior to the start of IVF ovarian stimulation. Aims: To investigate the efficacy of DHT gel treatment applied onto the skin before an IVF stimulation cycle in women with poor ovarian response. Research Hypothesis DHT pre-treatment prior to an IVF cycle will improve the number of healthy, fertilisable eggs retrieved.