Status:
ACTIVE_NOT_RECRUITING
FITMI - First In Treating Male Infertility
Lead Sponsor:
Martin Blomberg Jensen
Conditions:
Infertility, Male
Eligibility:
MALE
18-60 years
Phase:
PHASE2
Brief 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.
Detailed Description
Background and rationale Infertility is a common problem globally and impaired semen quality is responsible for up to 40% of all cases. Despite the high prevalence there are currently only very limite...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05212337
Start Date
January 1 2022
End Date
September 30 2025
Last Update
November 15 2024
Active Locations (1)
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1
Department of Growth and Reproduction, Rigshospitalet
Copenhagen, Denmark