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).
Who can participate
Age range18 Years – 60 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
The difference in sperm concentration (million pr. mL) on day 80