FITMI - First In Treating Male Infertility

• Status: Recruiting
• Trial end date: 2025-09-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Martin Blomberg Jensen
• Treatments: Denosumab

Criteria

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.