FITMI - First In Treating Male Infertility (NCT05212337) | Clinical Trial Compass
Active — Not RecruitingPhase 2
FITMI - First In Treating Male Infertility
Denmark180 participantsStarted 2022-01-01
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
The difference in sperm concentration (million pr. mL) on day 80