Trial to determine the absolute and relative efficacy of two follicular preparation
regimens with transdermal testosterone during the cycle (s) prior to the initiation of
COS (controlled ovarian stimulation) in patients diagnosed with POR (poor ovarian
response) for the increase in the number of mature oocytes recovered.

Clinical Trial to Assess the Effect of Testosterone in Patients With Poor Ovarian Response (TESTOPRIM)

Infertility, Female

POR is a challenge for reproductive medicine because of its impact on treatment outcomes
and the lack of sufficiently proven therapeutic tools. According to recent publications
based on retrospective studies of large registries, there is a correlation between the
number of oocytes and LBR (live birth rate), so the investigators consider that variable
mature oocytes are a reasonable compromise and a solid substitute for other outcome
variables such as LBR or CPR (clinical pregnancy rate).

Regarding the duration of treatment, the investigators decided to include two groups of
testosterone treatment (compared to the control group) with different duration. One will
explore the role of testosterone in prolonged treatments (two full menstrual cycles). The
other will test the pattern most commonly used in most studies, that is, testosterone in
luteal phase of the previous cycle (about 10 days in short protocol with GnRH
antagonist). In this way the investigators will establish an absolute comparison with the
control group and relative between both treatment groups (long testosterone vs. short
testosterone) to determine if / which of the two regimen (the two, only one or none)
improves the number of mature oocytes recovered.

The product under investigation is testosterone gel, transdermal administration, 50 mg /
single dose (Testim®, Ferring, Madrid, Spain). Regarding the dose, the investigators
decided to keep the most used in the rest of studies (12.5 mg / day).

This study population will include only patients diagnosed with POR based on ESHRE
Bologna criteria, in order to homogenize the population and allow comparisons with other
studies in the future.

Regarding the dose, the investigators decided to keep the most used in the rest of
studies (12.5 mg/day) which so far has been the only one proven effective. It is clearly
possible that lower and more physiological doses are equally effective, but this yet has
to be proven in well-designed studies. The gel is self-administered by the patients who
are adequately instructed by a research nurse.

GROUP 1: Long testosterone

GROUP 2: Short testosterone

GROUP 3: Control

Clinical Effect of Follicular Preparation With Testosterone in Poor Ovarian Response: a Randomized Controlled Clinical Trial (TESTOPRIM)

Determining whether a Follicular preparation with transdermal testosterone increases the
number of mature oocytes retrieved in patients diagnosed with Poor Ovarian Response and
which testosterone administration regimen is more effective for this purpose.

Quotient between the number of patients initiating COS and the total number of patients,
overall and in each group

Serum hormone levels of FSH, LH, E2, progesterone, testosterone, androstenedione, DHEA,
SHBG and FAI

Application of testosterone in transdermal gel during the 2 cycles prior to initiation of
controlled ovarian stimulation and until the onset of second menstruation (approximately
56 days). The COS begins the day after the last testosterone application.

Application of testosterone in transdermal gel begins on day 21 of menstrual cycle, from
the luteal phase of the cycle prior to initiation of controlled ovarian stimulation and
until menstruation (approximately 10 days). The COS begins the day after the last
testosterone application.

The COS starts directly on the second day of the cycle without prior medication.

Clinical Trial to Assess the Effect of Testosterone in Patients With Poor Ovarian Response (TESTOPRIM)

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

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