Subfertility Clinical Trial
Official title:
The Effect of Transdermal Testosterone Pretreatment in Poor Responders Undergoing Ovarian Stimulation for In-vitro Fertilization (IVF)
Ιt has been suggested that the accumulation of androgens in the micro milieu of the primate
ovary, plays a critical role in early follicular development and granulosa cell
proliferation. Increased intraovarian concentration of androgens seems to augment follicle
stimulating hormone (FSH) receptor expression in granulosa cells and thus, potentially
leading to enhanced responsiveness of ovaries to FSH. In addition, androgen excess has been
shown to stimulate early stages of follicular growth and increase the number of pre-antral
and antral follicles.
On the basis of these data, it has been hypothesized that increasing androgen concentration
in the ovarian micro milieu in poorly responding patients might lead to an increase in the
number and the maturity of oocytes after ovarian stimulation for IVF. Hence, recent efforts
have been focused on the potential benefit of androgen administration in the probability of
pregnancy in poor responders undergoing ovarian stimulation for IVF.
Pretreatment with transdermal testosterone has been suggested as a safe and effective way of
increasing the intraovarian androgen concentration. Recently, published, randomized control
trials (RCTs) have evaluated transdermal testosterone in poor responders undergoing ovarian
stimulation for IVF, with inconclusive results.
In view of the conflicting or inconclusive data regarding the efficacy of the proposed
intervention, this study will attempt to explore the role of transdermal testosterone
pretreatment in poor responders undergoing IVF through a properly designed RCT. The lack of
a universal definition of poor responders has been identified previously and recently, in an
attempt to address this issue, universal criteria for the definition of poor ovarian
response have been proposed following a consensus meeting in Bologna. In the present study,
the Bologna criteria will be used on the contrary to previous studies.
Despite the advancement in assisted reproduction technologies, poor ovarian response (POR)
is still considered to be one of the most challenging tasks in reproductive medicine. Poor
ovarian response is considered to be an inadequate response to ovarian stimulation, defined
usually by a low number of oocytes retrieved or a low number of developing follicles in a
previous or in the running, respectively, in vitro fertilization (IVF) cycle. Given the
severely diminished probability of pregnancy after IVF in these patients, the identification
of an indisputably efficacious treatment, such as testosterone pretreatment, would be a
promising alternative for poor responders undergoing IVF.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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