NAPO - Novel Approach for Oligospermia
This randomized controlled trial aims to assess whether treatment with denosumab can improve semen quality in infertile men selected by serum anti-mullerian hormone (AMH) as a positive predictive biomarker, and with severely impaired semen quality (concentrations between 0.01 million/mL to 2 million/mL).
- EligibilityCriteria: Inclusion Criteria:  Infertile men ≥ 18 years and < 60 years of age Sperm concentration ≤ 2 million pr. mL Serum AMH levels ≥28 pmol/L. The participants must have appropriate Danish or English language skills and give written informed consent.  Exclusion Criteria:  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 <0.01 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 albumin corrected calcium < 2,17 mmol/L or total calcium < 2.14 mmol/L Serum vitamin D (25OHD) levels < 25 nmol/L estimated Glomerular Filtration Rate (eGFR) < 60 mL/min/1,73 m2 Insufficient dental status Vasectomy Hypersensitivity to latex, Denosumab, or to any of the excipients (acetic acid, sodium hydroxide, Sorbitol (E420), Polysorbate 20) will be excluded. Serum FSH <3 IU/L Testis size > 17 mL BMI ≥ 35 kg/m2 - HealthyVolunteers: No - Gender: Male - MinimumAge: 18 Years - MaximumAge: 60 Years - StdAgeList: Adult