Denosumab and Male Infertility: a RCT

• Status: Active, not recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

To determine the significance of systemic RANKL inhibition for male reproduction, conducting a clinical controlled randomized double blinded intervention study on infertile men, to investigating whether Denosumab (Prolia) can increase semen quality and to investigate what subgroup of infertile men that might benefit from treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Martin Blomberg Jensen
• Treatments: Denosumab

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 <15 mio./ml or

• <40 % motile spermatozoer (A) or

• <4 % morphological normale spermatozoer (strict criteria)

Exclusion Criteria:

• Men with chronic diseases (diabetes mellitus, thyroid disease, endocrine diseases requiring 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

• Patients practising excessive exercise