Denosumab and male infertility: a randomized intervention study

Phase 1

Conditions: Male infertility
MedDRA version: 20.0Level: PTClassification code 10021929Term: Infertility maleSystem Organ Class: 10038604 - Reproductive system and breast disorders
Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

Registration Number: EUCTR2016-003546-84-DK

Lead Sponsor: Dpt. of Growth and Reproduction

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 90

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 <15 mio./ml or
<40 % motile spermatozoer (A) or
<4 % morphological normale spermatozoer (strict criteria)

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 95
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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