Status:
NOT_YET_RECRUITING
Supplementation for Male Subfertility
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
One Fertility
Conditions:
Male Infertility
Eligibility:
MALE
25-50 years
Phase:
PHASE2
Brief Summary
Old age, obesity, physical inactivity, environmental factors and genetics may contribute negatively to fertility in both males and females. In males, specifically, certain supplements, such as single ...
Detailed Description
BACKGROUND: Infertility is characterized by the failure to become pregnant after one year of regular intercourse without the use of contraceptives and impacts 10-15% of couples worldwide. Both male an...
Eligibility Criteria
Inclusion
- Males between the ages of 25-50 years diagnosed with subfertility through Ontario Networks of Experts in Fertility (ONE Fertility, Burlington, ON).
- For diagnosis of male subfertility, the 2010 and 2021 World Health Organization criteria will be used for sperm count, motility, morphology and vitality.
- Overweight and obese males according to body mass index (BMI) between the ages of 25-50 years.
Exclusion
- Smoking,
- history and drug alcohol abuse,
- BMI \> 30 kg/m2,
- genital disease (cryptorchidism, current genital inflammation, or varicocele),
- genital trauma or surgery to the male reproductive system,
- known Y chromosome microdeletions or karyotype abnormalities (if known prior),
- hepatobiliary disease,
- significant renal insufficiency,
- occupational exposures to reproductive toxins,
- endocrine abnormality,
- recent or current sexually transmitted infection,
- use of cytotoxic drugs,
- use of immunosuppressants,
- use of anticonvulsants,
- use of androgens or antiandrogens,
- history of central nervous system injury,
- neurological or psychiatric disease to potentially compromise study data collection,
- treatment of erectile dysfunction with any drugs during the past 4 weeks,
- history of cancer chemotherapy,
- current supplementation with ingredients being tested unless 1-month washout period
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 2 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06091969
Start Date
January 1 2025
End Date
February 2 2026
Last Update
October 10 2024
Active Locations (1)
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1
Mark Tarnopololsky
Hamilton, Ontario, Canada, L8N 3Z5