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ACTIVE NOT RECRUITING
NCT05212337
PHASE2
FITMI - First In Treating Male Infertility
Sponsor: Martin Blomberg Jensen
View on ClinicalTrials.gov
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.
Official title: Effect of a Single-dose Denosumab on Semen Quality in Infertile Men (FITMI): A Randomized Controlled Trial
Key Details
Gender
MALE
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2022-01-01
Completion Date
2025-09-30
Last Updated
2024-11-15
Healthy Volunteers
No
Conditions
Interventions
DRUG
Denosumab
Subcutaneous injection with 60 mg Denosumab once
DRUG
Sodium chloride
Subcutaneous injection with NaCl once
Locations (1)
Department of Growth and Reproduction, Rigshospitalet
Copenhagen, Denmark