Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT06091969
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
25 Years
Maximum Age:
50 Years
Study:
NCT06091969
Study Brief:
Protocol Section:
NCT06091969