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Denosumab and Male Infertility: a RCT

NCT03030196 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2023-06-13

No results posted yet for this study

Summary

To determine the significance of systemic RANKL inhibition for male reproduction, conducting a clinical controlled randomized double blinded intervention study on infertile men, to investigating whether Denosumab (Prolia) can increase semen quality and to investigate what subgroup of infertile men that might benefit from treatment.

Conditions

  • Infertility, Male

Interventions

DRUG

Denosumab

NaCl 0.9% injection is used as placebo

Sponsors & Collaborators

  • Martin Blomberg Jensen

    lead OTHER

Principal Investigators

  • Li J Mortensen, MD · Rigshospitalet, Dpt. of Growth and Reproduction, section GR 5064, Blegdamsvej 9, 2100 Copenhagen, Denmark

  • martin Blomberg Jensen, MD · Rigshospitalet, Dpt. of Growth and Reproduction, section GR 5064, Blegdamsvej 9, 2100 Copenhagen, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2021-01-31
Completion
2023-05-31

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 NCT03030196 on ClinicalTrials.gov