Male infertility MedDRA version: 20.0 Level: PT Classification code 10021929 Term: Infertility male System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Trade Name: Prolia Denosumab
Product Name: Denosumab
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Denosumab
CAS Number: 615258-40-7
Other descriptive name: DENOSUMAB
Concentration
Sponsors
Dpt. of Growth and Reproduction
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Men > 18 years of age refered due to infertility in need for further investigation with Sperm count > 0,05 mio./ml. The men have either sperm count =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Men with chronic diseases (diabetes mellitus, thyroid disease, endocrine diseases requirering treatment, malignant diseases or diseases known to be affected by- or interfere with vitamin D supplements (granulomatous diseases such as sarcoidosis, tuberculosis, wegeners, vasculitis as well as inflammatory bowel diseases e.g. chron’s disease or ulcerative colitis etc). Men with active or previous malignant disease Any case with indication for tesis biopsy, Serum ionized calcium < 1,15 mmol/l Total calcium < 2.14 mmol/l Poor dental status og dental implants Men with obstructive oligospermia or who has been vasectomized Serum Inhibin B < 30 pg/ml Abnormal karyotype
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this intervention is to investigate whether Denosumab can improve semen quality of infertile men;Secondary Objective: differences in clinical pregnancies, Inhibin B, DNA fragmentation in spermatozoa, differences in semen quality;Primary end point(s): Change in semen production (total motile spermatozoa, progressive motile spermatozoa, spermatozoa-count, spermatozoa-concentration);Timepoint(s) of evaluation of this end point: Respectively 80 days and 160 days after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in semen quality (-motility, -morphology og semenvolume) Change in DNA fragmentation (DFI) in spermatozoa Change in serum Inhibin-B conc. Change in serum levels of reproductive hormonea (FSH, LH, AMH, testosterone, estradiol, SHBG and prolactin) Change in bone mineral density evaluated by DXA. Change in serum level of inactive vitamin D, 1,25(OH)2D3, 25-OHD3, 24,25(OH)2D3, PTH, alkaline phosphatase, ionized calcium, phosphate, FGF23, Klotho, osteocalcin, osteopontin, calcitonin, pnp, procollagen III, OPG, RANKL, Sclerostin as well as other bone marker. Change in choice of assisted reproductive assistance technique as well as conceived pregnancies Change in spontaneous conception rate Change in live birth rate Change in number of spermatozoa expressing RANKL Change in semen pH, HCO3-, calcium, zink, phosphate, RANKL, RANK, OPG, FGF23, Klotho, osteocalcin, osteopontin. Difference in infection rate in the two groups ;Timepoint(s) of evaluation of this end point: Respectively 14 days, 80 days, 160 and 365 days after intervention | — |
Countries
Denmark
Contacts
Public ContactSecretariat
Dpt.of Growth and Reproduction
Outcome results
None listed