Supplementation for Male Subfertility

Launched by HAMILTON HEALTH SCIENCES CORPORATION · Oct 16, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how a new combination supplement, called Fertility Enhancer, might help improve sperm function in men who are overweight or obese and struggling with fertility. The researchers believe that by using a mix of different nutrients—like vitamins, antioxidants, and amino acids—they can target various issues that affect sperm health, especially in men aged 25 to 50. The study will last for three months and will compare the new supplement to a placebo (a dummy treatment with no active ingredients) to see if it really makes a difference.

To participate in this trial, men must be diagnosed with subfertility and be between 25 and 50 years old, with a body mass index (BMI) that indicates they are overweight or obese. However, there are certain health conditions that would exclude someone from joining the study, such as smoking, certain types of surgeries, or specific diseases. Participants can expect to take the supplement daily and have their sperm function monitored throughout the trial. This study is important because it could lead to new ways to help men improve their fertility through nutrition.

Gender

MALE

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