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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

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