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Study on Denosumab for Improving Semen Quality in Men with Infertility

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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 oligospermia, which is characterized by a low sperm count. The study aims to explore whether a medication called Denosumab can help improve the quality of semen in men who are experiencing infertility. Denosumab is administered as a solution for injection. Participants in the study will receive either Denosumab or a placebo, which is a substance with no active medication.

The purpose of the study is to determine if Denosumab can enhance sperm quality in men with reduced sperm production. Throughout the study, participants will receive injections and provide semen samples at specific intervals. The study will compare the sperm concentration and quality between those receiving Denosumab and those receiving the placebo. Additionally, the study will monitor changes in reproductive hormone levels, such as FSH (Follicle-Stimulating Hormone), LH (Luteinizing Hormone), AMH (Anti-Müllerian Hormone), and Inhibin B, which are important for understanding fertility health.

The study will also observe any differences in the occurrence of spontaneous pregnancies and any changes in the number of spontaneous abortions during the trial period. Participants will be followed over a period of time to assess these outcomes, with the final evaluation taking place at the end of the study. The results will help determine if Denosumab is effective in improving fertility in men with oligospermia.

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 visit

    Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as age and sperm concentration.

    A blood sample will be taken to measure hormone levels, including AMH (anti-Müllerian hormone).

  2. Step 2

    Baseline semen sample

    You will provide a semen sample to establish a baseline for sperm concentration and quality. This will help in comparing changes throughout the study.

  3. Step 3

    Medication administration

    You will receive a subcutaneous injection of either Prolia (denosumab) or a placebo (saline). The injection will be administered under the skin using a pre-filled syringe.

    The dosage for Prolia is 60 mg, and it will be given once at the start of the trial.

  4. Step 4

    Follow-up visits

    You will attend follow-up visits to monitor your progress. These visits will include assessments of your health and any side effects you may experience.

    Additional blood samples may be taken to measure hormone levels.

  5. Step 5

    Day 80 semen sample

    On day 80, you will provide another semen sample. This sample will be used to evaluate changes in sperm concentration and quality compared to the baseline sample.

  6. Step 6

    Final assessments

    At the end of the trial, final assessments will be conducted. These may include a review of any changes in reproductive hormones and overall semen quality.

    The study will also track any spontaneous pregnancies and any changes in your health status.

Who can join the trial?

4 criteria

  • Must be a man.
  • Must be older than 18 years and younger than 60 years.
  • Must have reduced sperm production, which means having a sperm concentration of less than 2 million per milliliter.
  • Must have a serum AMH level greater than 30 pmol/L. AMH is a hormone that can be measured in the blood.

Who cannot join the trial?

3 criteria

  • Patients who are not male cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.
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Investigated drugs

Denosumab is a medication that is being studied to see if it can help improve semen quality in men who have trouble with fertility. It works by affecting the bones and the cells that break down bone tissue. In this trial, researchers are exploring whether this medication can have a positive effect on sperm production and quality, which might help some men with fertility issues. The goal is to see if Denosumab can make a difference in the ability of these men to father children.

What is already known about the treatment

Denosumab – Denosumab is administered as an injection under the skin, typically in the upper arm, thigh, or abdomen. It is currently being studied in clinical trials to assess its potential benefits in treating male infertility, specifically in improving semen quality in men with oligospermia, a condition characterized by low sperm count. The medication works by targeting a protein involved in bone metabolism, which may have effects on reproductive health. Denosumab is classified as a monoclonal antibody, a type of drug designed to interact with specific proteins in the body.

Investigated diseases

Male infertility – Male infertility is a condition where a man has a reduced ability to father a child. It can result from various factors affecting sperm production, function, or delivery. The condition may involve low sperm production, abnormal sperm function, or blockages that prevent the delivery of sperm. As the condition progresses, it may lead to a decrease in sperm concentration and motility. Changes in reproductive hormone levels, such as FSH, LH, AMH, and Inhibin B, can also occur. These hormonal changes can further impact sperm quality and fertility potential.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-508325-27-00Estimated enrolment60 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

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