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Study of transdermal testosterone gel to improve ovarian response in women with low ovarian reserve and androgen receptor polymorphism undergoing fertility treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on women with low ovarian reserve who are carriers of a specific androgen receptor polymorphism. The research aims to determine if pretreatment with testosterone gel can improve outcomes in patients undergoing fertility treatment called intracytoplasmic sperm injection (a procedure where a single sperm is injected directly into an egg).

The treatment involves applying testosterone gel to the skin daily for 21 days. After this pretreatment period, participants will receive several fertility medications including follitropin alfa, ganirelix, and triptorelin. Some participants will receive the testosterone gel while others will receive a placebo gel containing purified water. The medications are given through injections under the skin, except for the testosterone gel which is applied to the skin.

The study will examine whether this treatment approach can increase the number of eggs that can be collected during the fertility procedure. The research will also look at other aspects of fertility treatment success, including how many embryos develop and whether pregnancy occurs.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will begin treatment with transdermal testosterone gel (1% concentration). The gel needs to be applied to your skin daily.

    This initial phase aims to prepare your body for the following treatments.

  2. Step 2

    Ovarian stimulation start

    You will receive daily subcutaneous injections (under the skin) of Bemfola (follitropin alfa), which stimulates your ovaries.

    These injections will continue throughout the stimulation phase of the treatment.

  3. Step 3

    Prevention of early ovulation

    Daily subcutaneous injections of Decapeptyl (triptorelin) 0.1 mg will be administered to prevent premature ovulation.

    When needed, Astarté (ganirelix) 0.25 mg will also be given by subcutaneous injection for the same purpose.

  4. Step 4

    Monitoring phase

    Your response to the medications will be monitored through regular ultrasound examinations.

    Blood tests will be performed to check hormone levels.

  5. Step 5

    Egg retrieval procedure

    Once your eggs have reached the appropriate size, they will be collected through a minor surgical procedure.

    The collected eggs will be evaluated to determine their maturity and quality.

  6. Step 6

    Laboratory procedures

    Your eggs will undergo intracytoplasmic sperm injection (ICSI), a procedure where a single sperm is injected directly into each mature egg.

    The fertilized eggs will be monitored for development to the blastocyst stage (advanced embryo stage).

Who can join the trial?

14 criteria

  • Must have low ovarian reserve meeting at least two of these conditions:
    • Age 40 or older
    • Previous fertility treatment yielding fewer than 4 eggs
    • Low markers of ovarian function (fewer than 5-7 antral follicles or AMH hormone level below 0.5-1.1 ng)
    • Must have a specific genetic variation in the androgen receptor gene (22-24 CAG repeats)
    • Body weight must be within certain limits (BMI less than 32)
    • Must be recommended for in vitro fertilization (IVF) treatment
    • Must have both ovaries present
    • Must not have ovarian cysts (fluid-filled sacs in the ovaries)
    • Must not have endometriosis (condition where uterine tissue grows outside the uterus)
    • Must have normal results on genetic testing (karyotype and fragile X tests)
    • Partner must not have severe male fertility issues
    • Partner must be able to provide sperm sample through ejaculation
    • Must be able to follow all study requirements
    • Must provide written consent to participate

Who cannot join the trial?

10 criteria

  • Age outside of 18-65 years range
  • Male patients (study is for female participants only)
  • Patients who do not have low ovarian reserve (reduced ability of ovaries to produce eggs)
  • Patients who are not carriers of androgen receptor polymorphism (specific genetic variation in hormone receptors)
  • Patients who are not planning to undergo intracytoplasmic sperm injection (a fertility treatment where a single sperm is injected directly into an egg)
  • Patients with contraindications to transdermal testosterone (hormone treatment applied through the skin)
  • Patients who are currently participating in other clinical trials
  • Patients unable to provide informed consent
  • Patients with known allergies to study medications
  • Pregnant or breastfeeding women
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Investigated drugs

  • Transdermal Testosterone

    This is a hormone medication that is applied to the skin and absorbed through it into the bloodstream. It's a form of testosterone therapy used to increase testosterone levels in the body. In this trial, it's used as a pretreatment for women with low ovarian reserve before they undergo fertility treatment. The medication aims to help improve the ovarian response and increase the number of eggs that can be retrieved during the fertility procedure.

  • Intracytoplasmic Sperm Injection (ICSI)

    This is a specialized fertility treatment procedure where a single sperm is directly injected into an egg in the laboratory. While not a medication, it's a key therapy in this trial that helps achieve fertilization, especially useful in cases where traditional IVF methods might be less successful.

What is already known about the treatment

Transdermal Testosterone - A hormone medication administered through the skin via patches or gels that allows for steady absorption into the bloodstream. In clinical trials, it is being investigated for treating women with low ovarian reserve and specific androgen receptor genetic variations, particularly before fertility treatments like intracytoplasmic sperm injection (ICSI). This medication belongs to the class of androgens and works by directly increasing androgen levels in the body, which may help improve ovarian response during fertility treatments. The therapy aims to enhance the number of viable eggs that can be retrieved during assisted reproductive procedures by potentially improving follicular development and ovarian stimulation outcomes.

Investigated diseases

  • Low Ovarian Reserve

    A condition where a woman's ovaries contain fewer eggs than expected for her age. It is characterized by reduced quantity and sometimes quality of remaining eggs in the ovaries. The condition can be identified through specific medical markers and affects the normal reproductive function. Women with this condition typically produce fewer eggs during ovulation. Low ovarian reserve can occur naturally with aging or may develop earlier in some women due to genetic factors or other causes.

  • Androgen Receptor Polymorphism

    A genetic variation that affects how the body responds to androgens (male hormones). This condition involves changes in the androgen receptor gene, which can alter how cells respond to hormones like testosterone. The polymorphism can affect various bodily functions where androgens play a role. These genetic variations can influence reproductive function and hormone sensitivity in both men and women.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510596-37-01Estimated enrolment100 patientsSponsorInstituto Bernabeu S.L.

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