CompletedPhase 1/2

NAPO - Novel Approach for Oligospermia

Denmark42 participantsStarted 2024-03-01

Plain-language summary

This randomized controlled trial aims to assess whether treatment with denosumab can improve semen quality in infertile men selected by serum anti-mullerian hormone (AMH) as a positive predictive biomarker, and with severely impaired semen quality (concentrations between 0.01 million/mL to 2 million/mL).

Who can participate

Age range

18 Years – 60 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Infertile men ≥ 18 years and \< 60 years of age * Sperm concentration ≤ 2 million pr. mL * Serum AMH levels ≥28 pmol/L. * The participants must have appropriate Danish or English language skills and give written informed consent. Exclusion Criteria: * Chronic diseases, defined as diagnosis where signs, symptoms, and treatment imply an expected long duration and lack of a cure, such as diabetes mellitus, metabolism disorders, osteoporosis, colitis, etc. * Sperm concentration \<0.01 million pr. mL * Men with current or previous malignancies, or at potential risk of testicular cancer after baseline examination and ultrasound will be excluded. * Men with hypocalcemia at baseline, defined as albumin corrected calcium \< 2,17 mmol/L or total calcium \< 2.14 mmol/L * Serum vitamin D (25OHD) levels \< 25 nmol/L * estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min/1,73 m2 * Insufficient dental status * Vasectomy * Hypersensitivity to latex, Denosumab, or to any of the excipients (acetic acid, sodium hydroxide, Sorbitol (E420), Polysorbate 20) will be excluded. * Serum FSH \<3 IU/L * Testis size \> 17 mL * BMI ≥ 35 kg/m2

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The difference in sperm concentration (million pr. mL) on day 80

Timeframe: Day 80 and day 83 after inclusion

Trial details

NCT IDNCT06300229

SponsorMartin Blomberg Jensen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-29

View on ClinicalTrials.gov More Infertility, Male trials