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Study on Denosumab for Improving Semen Quality in Men with Non-Obstructive Azoospermia

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying male infertility, specifically a condition known as Non-Obstructive Azoospermia. This condition affects some men who have no sperm in their semen, but without any blockage in the reproductive tract. The trial will investigate whether a medication called Denosumab, which is usually given as a solution for injection, can help improve semen quality in these men.

The purpose of the study is to explore if Denosumab can lead to the presence of sperm in semen samples or through a procedure called Testicular Sperm Extraction (TESE) after 90 days. Participants will receive the treatment and have their semen and hormone levels checked at different times during the study. The study will also look at changes in reproductive hormones and the function of the testes, which are the organs that produce sperm and hormones.

Throughout the study, participants will have regular assessments to monitor any changes in their condition. The trial aims to provide valuable insights into whether Denosumab can be an effective treatment for improving fertility in men with this specific type of infertility. The study is expected to continue until mid-2025, with recruitment starting in 2024.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, semen volume, testicle size, and hormone levels.

    Participants must be infertile men aged between 18 and 60 years with non-obstructive azoospermia.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to collect baseline data. This includes semen samples and possibly a testicular biopsy if previous data is available.

    Blood samples are taken to measure hormone levels.

  3. Step 3

    Medication administration

    The medication Prolia, containing denosumab, is administered as a subcutaneous injection. The dosage is 60 mg.

    The injection is given at the start of the trial.

  4. Step 4

    Follow-up assessments

    Follow-up assessments occur at day 14 and day 80. These include semen samples and blood tests to monitor changes in hormone levels.

    The focus is on changes in reproductive and sex hormones, as well as the presence of sperm in the semen.

  5. Step 5

    Final assessment

    On day 90, a final assessment is conducted. This may include another semen sample and possibly a testicular biopsy.

    The primary goal is to identify sperm in the semen or biopsy and compare it with previous data.

  6. Step 6

    End of participation

    Participation in the trial concludes after the final assessment.

    Results are analyzed to determine the effectiveness of the treatment in improving semen quality.

Who can join the trial?

4 criteria

  • Men who are unable to have children, aged over 18 and under 60 years old, with a condition called azoospermia. This means there is no sperm in the semen, but the amount of semen is normal. This must be confirmed with at least two semen tests.
  • The size of the testicles, measured with a tool called a Prader orchidometer, should be 15 milliliters or less on both sides.
  • There should be no known reasons for any blockages that might prevent sperm from being present.
  • The level of a hormone in the blood called AMH (Anti-Müllerian Hormone) should be 28 picomoles per liter or higher.

Who cannot join the trial?

3 criteria

  • Individuals who are not male cannot participate in the study.
  • Participants must be within a specific age range, typically adults, to be eligible.
  • Individuals who are considered part of a vulnerable population, such as those with certain health conditions or disabilities, are not eligible.
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Investigated drugs

Denosumab is a medication being studied to see if it can improve semen quality in some infertile men. It is typically used to treat bone-related conditions by affecting the cells that break down bone tissue. In this trial, researchers are exploring its potential benefits for men with a specific type of infertility called non-obstructive azoospermia, where there is a lack of sperm in the semen not caused by a blockage.

What is already known about the treatment

Denosumab – Denosumab is administered as an injection under the skin. It is currently being studied for its potential to improve semen quality in men with non-obstructive azoospermia, a condition related to male infertility. The medication works by inhibiting a protein involved in bone resorption, which may have effects on reproductive health. Denosumab is classified as a monoclonal antibody and is primarily used in other contexts to treat bone-related conditions.

Investigated diseases

Male infertility – Male infertility refers to a man's inability to cause pregnancy in a fertile female. It can result from various factors, including low sperm production, abnormal sperm function, or blockages that prevent the delivery of sperm. Hormonal imbalances, genetic defects, and lifestyle factors such as smoking and alcohol use can also contribute. The condition may manifest as a low sperm count, poor sperm motility, or abnormal sperm shape. In some cases, the cause of male infertility is unknown, making it idiopathic. The progression of male infertility can vary, with some men experiencing a gradual decline in fertility over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512996-11-00Estimated enrolment16 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

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