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NAPO - Novel Approach for Oligospermia

NCT06300229 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-12-19

No results posted yet for this study

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).

Conditions

  • Infertility, Male

Interventions

DRUG

Denosumab

Subcutaneous injection with 60 mg Denosumab once

DRUG

sodium chloride

Subcutaneous injection with NaCl once

Sponsors & Collaborators

  • Martin Blomberg Jensen

    lead OTHER

Principal Investigators

  • Sam Kafai Yahyavi, MD · Division of Translational Endocrinology, Herlev, Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-01-29
Completion
2025-08-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06300229 on ClinicalTrials.gov