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
Concentration unit: mg milligram(s)
Concentrat
Sponsors
Dept. of Growth and Reproduction
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Infertile men >18 years and 38 pmol/L Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 282 F.1.3 Elderly (>=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 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 - Men in treatment for osteoporosis - Serum ionized calcium < 1,18 mmol/L, Total calcium < 2.14 mmol/L or Albumin corrected calcium <2.17 mmol/L - Serum 25OHD < 25 nmol/L - eGFR <60 mL/min/1.73m^2 - Poor dental status og dental implants - Men with obstructive oligospermia (Sperm volume <0.9 mL) or who has been vasectomized - Latex allergy - Any case with indication for tesis biopsy,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this intervention is to investigate whether Denosumab can improve semen quality in a sub-group of infertile men.;Secondary Objective: Differences in clinical pregnancies, reproductive hormones, and differences in semen quality.;Primary end point(s): Differences in sperm production (sperm concentration millions/mL);Timepoint(s) of evaluation of this end point: 80 days after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Difference in sperm quality (total number of sperm, total number of motile sperm, percentage of total motile sperm, total number of progressive motile sperm and percentage of progressive motile sperm, total number of morphologically normal sperm and percentage of morphologically normal sperm) - Difference in pregnancies achieved spontaneously or at IUI before day 180. - Difference in the number of live-born children where pregnancy is achieved spontaneously or at IUI before day 180. - Difference in the number of live-born children where pregnancy is achieved by artificial insemination (IVF and ICSI) before day 180. - Difference in the number of spontaneous abortions in the trial period. - Difference in serum levels of reproductive hormones (FSH, LH, AMH, Inhibin B and INSL3) on day 80. - Difference in serum levels of sex hormones (Testosterone, estradiol and SHBG) on day 80. - Difference in endocrine gonadal function (Inhibin B/FSH ratio and testosterone/LH ratio) on day 80.;Timepoint(s) of evaluation of this end point: Day 80, 180 and 450. | — |
Countries
Denmark
Contacts
Public ContactSekretariatet
Dept. of Growth and Reproduction
Outcome results
None listed