At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 42 enrolled
Drug / intervention
Denosumab +1 moredrug
Likely dose
Denosumab 60 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Novel Approach for Oligospermia (NAPO): A Randomized Controlled Trial
In Brief
A Phase 2 clinical trial evaluating Denosumab and sodium chloride for Infertility, Male. Completed, enrolled 42 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility, Male
CountriesDenmark
Collaborators--
Timeline
Phase 2CompletedFinished
20252026
Enrollment StartMar 2024
First PostedMar 2024
Primary CompletionJan 2025
Study CompletionAug 2025
TodayJul 2026
First PostedMar 8, 2024
Enrollment StartMar 1, 2024
Primary CompletionJan 29, 2025
Study CompletionAug 31, 2025
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 2.3 years ago
Interventions
Denosumabdrug
Subcutaneous injection with 60 mg Denosumab once
sodium chloridedrug
Subcutaneous injection with NaCl once