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Denosumab and Male Infertility: a RCT

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ClinicalTrials.gov Identifier: NCT03030196
Recruitment Status : Recruiting
First Posted : January 24, 2017
Last Update Posted : May 23, 2017
Sponsor:
Information provided by (Responsible Party):
Martin Blomberg Jensen, Rigshospitalet, Denmark

Brief 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.

Condition or disease Intervention/treatment Phase
Infertility, Male Drug: Denosumab Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Denosumab and Male Infertility: a Randomized Controlled Double-blinded Intervention Study
Actual Study Start Date : January 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021


Arm Intervention/treatment
Active Comparator: Denosumab
subcutaneous injection with 60 mg Denosumab once
Drug: Denosumab
NaCl 0.9% injection is used as placebo
Other Name: Prolia

Placebo Comparator: Placebo
subcutaneous injection with NaCl once
Drug: Denosumab
NaCl 0.9% injection is used as placebo
Other Name: Prolia




Primary Outcome Measures :
  1. Change in semen production (total motile spermatozoa, progressive motile spermatozoa, spermatozoa-count, spermatozoa-concentration) [ Time Frame: 80 days and 160 days after intervention ]
    semen analysis


Secondary Outcome Measures :
  1. Change in semen quality (-motility, -morphology of semen volume) [ Time Frame: 80 days,160 days after intervention ]
    semen analysis

  2. Change in DNA fragmentation (DFI) in spermatozoa [ Time Frame: 80 days after intervention ]
    semen analysis

  3. Change in serum Inhibin-B concentration [ Time Frame: 80 days and 160 days after intervention ]
    blood sample

  4. Change in serum levels of reproductive hormonea (FSH, LH, AMH, testosterone, estradiol and SHBG) [ Time Frame: 80 days and 160 days after intervention ]
    blood sample

  5. Change in bone mineral density evaluated by DXA [ Time Frame: 80 days and 160 days after intervention ]
    DXA

  6. • 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 [ Time Frame: 80 days and 160 days after intervention ]
    blood sample

  7. Change in choice of assisted reproductive assistance technique as well as conceived pregnancies [ Time Frame: 80 days,160 days and 365 days after intervention ]
    patient file

  8. Change in spontaneous conception rate. [ Time Frame: 80 days,160 days and 365 days after intervention ]
    patient file, interview

  9. Change in number of spermatozoa expressing RANKL [ Time Frame: 80 days and 160 days after intervention ]
    cytospin

  10. Change in semen pH, HCO3-, calcium, zink, phosphate, RANKL, RANK, OPG, FGF23, Klotho, osteocalcin, osteopontin. [ Time Frame: 80 days and 160 days after intervention ]
    seminal anlysis

  11. Difference in infection rate in the two groups [ Time Frame: 80 days and 160 days after intervention ]
    patient history

  12. Change in serum level of osteopontin, calcitonin, pnp, procollagen III, OPG, RANKL, Sclerostin as well as other bone marker [ Time Frame: 80 days and 160 days after intervention ]
  13. Change in live birth rate [ Time Frame: 80 days,160 days and 365 days after intervention ]
    patient file tlephoen interview



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030196


Contacts
Contact: Li J Mortensen, MD +45 35459456 li.juel.mortensen@regionh.dk
Contact: Martin Blomberg Jensen, MD +45 35451865 martin.blomberg.jensen@regionh.dk

Locations
Denmark
Department of Growth and Reproduction, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Li Juel Mortensen, MD    +4535459456      
Sponsors and Collaborators
Martin Blomberg Jensen
Investigators
Principal Investigator: Li J Mortensen, MD Rigshospitalet, Dpt. of Growth and Reproduction, section GR 5064, Blegdamsvej 9, 2100 Copenhagen, Denmark
Study Chair: martin Blomberg Jensen, MD Rigshospitalet, Dpt. of Growth and Reproduction, section GR 5064, Blegdamsvej 9, 2100 Copenhagen, Denmark

Publications:

Responsible Party: Martin Blomberg Jensen, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03030196     History of Changes
Other Study ID Numbers: 01112016
2016-003546-84 ( EudraCT Number )
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: May 23, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs