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)
The difference in sperm concentration (million pr. mL) on day 80 — Day 80 and day 83 after inclusion Semen analysis - The average concentration of two semen samples delivered on day 80 and day 83 after inclusion is used.
Trial sites (1)
Facility
City
Region
Status
Department of Growth and Reproduction, Rigshospitalet
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.
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