NAPO - Novel Approach for Oligospermia

Phase 1
Recruiting
Conditions
Interventions
Registration Number
NCT06300229
Lead Sponsor
Martin Blomberg Jensen
Brief Summary

This randomized controlled trial aims to assess whether treatment with denosumab can improve semen quality in infertile men selected by serum anti-mullerian hormone (AMH) as a positive predictive biomarker, and with severely impaired semen quality (concentrations between 0.01 million/mL to 2 million/mL).

Detailed Description

Infertility is a common problem globally and impaired semen quality is responsible for up to 40% of all cases. Despite the high prevalence there are currently only very limited treatment options to improve semen quality for infertile men. Instead, almost all infertile couples are treated with inseminations or assisted reproductive techniques (ARTs) independe...

Recruitment & Eligibility

Status
RECRUITING
Sex
Male
Target Recruitment
42
Inclusion Criteria
  • Infertile men ≥ 18 years and < 60 years of age
  • Sperm concentration ≤ 2 million pr. mL
  • Serum AMH levels ≥28 pmol/L.
  • The participants must have appropriate Danish or English language skills and give written informed consent.
Read More
Exclusion Criteria
  • Chronic diseases, defined as diagnosis where signs, symptoms, and treatment imply an expected long duration and lack of a cure, such as diabetes mellitus, metabolism disorders, osteoporosis, colitis, etc.
  • Sperm concentration <0.01 million pr. mL
  • Men with current or previous malignancies, or at potential risk of testicular cancer after baseline examination and ultrasound will be excluded.
  • Men with hypocalcemia at baseline, defined as albumin corrected calcium < 2,17 mmol/L or total calcium < 2.14 mmol/L
  • Serum vitamin D (25OHD) levels < 25 nmol/L
  • estimated Glomerular Filtration Rate (eGFR) < 60 mL/min/1,73 m2
  • Insufficient dental status
  • Vasectomy
  • Hypersensitivity to latex, Denosumab, or to any of the excipients (acetic acid, sodium hydroxide, Sorbitol (E420), Polysorbate 20) will be excluded.
  • Serum FSH <3 IU/L
  • Testis size > 17 mL
  • BMI ≥ 35 kg/m2
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
DenosumabDenosumabSubcutaneous injection with 60 mg Denosumab once
Placebosodium chlorideSubcutaneous injection with NaCl once
Primary Outcome Measures
NameTimeMethod
The difference in sperm concentration (million pr. mL) on day 80Day 80 and day 83 after inclusion

Semen analysis - The average concentration of two semen samples delivered on day 80 and day 83 after inclusion is used.

Secondary Outcome Measures
NameTimeMethod
The change/difference in serum levels of follicle stimulating hormone (FSH) on day 80Day 80 after inclusion

Serum sample

The difference in semen quality (total sperm count, motile sperm, progressive motile sperm and morphologically normal sperm) between baseline and two semen samples delivered at day 80 and day 83 after inclusionDay 80 and day 83 after inclusion

Semen analysis

The difference in the number of miscarriages throughout the trial before day 180Day 450 after inclusion]

Survey

The change/difference in serum levels of reproductive hormone Inhibin B on day 80Day 80 after inclusion

Serum sample

The change/difference in serum levels of reproductive hormone AMH on day 80Day 80 after inclusion

Serum sample

The change/differences in number of pregnancies achieved before day 180Day 180 after inclusion

Survey

The change/difference in serum levels of reproductive hormone luteinizing hormone (LH) on day 80Day 80 after inclusion

Serum sample

Trial Locations

Locations (1)

Division of Translational Endocrinology, Department of Endocrinology and Internal Medicine

🇩🇰

Copenhagen, Denmark

© Copyright 2024. All Rights Reserved by MedPath