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Clinical Trials in Denmark / NCT05212337
Active, not recruiting Phase 2

FITMI - First In Treating Male Infertility

NCT05212337 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 2
Started
2022-01-01
Last updated
2024-11-15

Condition(s) studied

Infertility, Male

Investigational drug(s) / intervention(s)

Denosumab →Sodium chloride

Denosumab: Subcutaneous injection with 60 mg Denosumab once

Sodium chloride: Subcutaneous injection with NaCl once

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criterias: * Infertile men ≥ 18 years and \< 60 years of age * Sperm concentration ≤ 20 million pr. mL * Serum AMH levels ≥38 pmol/L. * The participants must have appropriate Danish or English language skills and give written informed consent. Exclusion Criterias: * Chronic diseases, defined as diagnosis where signs, symptoms, and treatment imply an expected long duration and lack of a cure, such as diabetes mellitus, metabolism disorders, osteoporosis, colitis, etc. * Sperm concentration \<2 million pr. mL * Men with current or previous malignancies, or at potential risk of testicular cancer after baseline examination and ultrasound will be excluded. * Men with hypocalcemia at baseline, defined as ionized calcium of \< 1,18 mmol/L or albumin corrected calcium \< 2,17 mmol/L or total calcium \< 2.14 mmol/L * Serum vitamin D (25OHD) levels \< 25 nmol/L * eGFR \< 60 mL/min/1,73 m2 * Insufficient dental status * Vasectomy * Semen volume \< 0.9 mL * Hypersensitivity to latex, Denosumab, or to any of the excipients (acetic acid, sodium hydroxide, Sorbitol (E420), Polysorbate 20) will be excluded.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Growth and Reproduction, Rigshospitalet Copenhagen Denmark

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05212337 on ClinicalTrials.gov ↗ ← All trials in Denmark