CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 180 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.

Search/NCT05212337
NCT05212337Phase 2Active
CompareCT.gov

Effect of a Single-dose Denosumab on Semen Quality in Infertile Men (FITMI): A Randomized Controlled Trial

Martin Blomberg Jensen·interventional·Posted Jan 28, 2022·Updated Nov 15, 2024

In Brief

A Phase 2 clinical trial evaluating Denosumab and Sodium chloride for Infertility, Male. Active but no longer recruiting, targeting 180 participants across 1 site.

Detailed Summary

This RCT aims to assess whether treatment with Denosumab can improve semen quality in infertile men selected by serum AMH as a positive predictive biomarker.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility, Male
CountriesDenmark
Collaborators--

Timeline

Phase 2ActiveOverdue
20222023202420252026
First PostedJan 28, 2022
Enrollment StartJan 1, 2022
Primary CompletionOct 22, 2024
Study CompletionSep 30, 2025
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 4.4 years ago

Interventions

Denosumabdrug

Subcutaneous injection with 60 mg Denosumab once

Sodium chloridedrug

Subcutaneous injection with NaCl once