Active multi-ingredient supplement (Fertility Enhancer, FE)Inactive placebo (Placebo; PLA)
Active multi-ingredient supplement (Fertility Enhancer, FE): Consuming a multi-ingredient supplement targeting multiple cell pathways daily for 3 months.
Inactive placebo (Placebo; PLA): Consuming an inactive placebo that is calorie-matched to the active supplement daily for 3 months.
Study 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 antioxidants and trace minerals, have previously been shown to improve sperm function marginally. One hypothesis is that sperm function can be improved even further by combining several different types of supplements (e.g., amino acids, energy carriers, vitamins, antioxidants, and trace minerals) to target several age-related cell pathways, for example, oxidative stress, mitochondrial dysfunction, inflammation and cell energetics. This 3-month placebo-controlled, randomized clinical trial, aims to test the effects of a novel multi-ingredient supplement (Fertility Enhancer) that targets several age-related cell pathways on sperm function in overweight or obese and subfertile males.
Eligibility
Sex
MALE
Min age
25 Years
Max age
50 Years
Healthy volunteers
Accepted
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
Primary outcome measure(s)
Percent change in body composition index from baseline to 3 months — Baseline to 3 months Lean mass/fat mass ratio by dual X-ray absorptiometry scan (body composition index; % change)
Percent change in total fat mass from baseline to 3 months — Baseline to 3 months Total fat mass by dual X-ray absorptiometry scan (kg; % change)
Percent change in sperm count/concentration from baseline to 3 months — Baseline to 3 months Sperm count/concentration (millions spermatozoa/mL semen)
Percent change in sperm motility from baseline to 3 months — Baseline to 3 months Proportion motile sperm (%)
Percent change in sperm morphology from baseline to 3 months — Baseline to 3 months Proportion normal sperm morphology (%)
Percent change in sperm vitality from baseline to 3 months — Baseline to 3 months Proportion viable sperm (vitality) (%)
Trial sites (1)
Facility
City
Region
Status
Mark Tarnopololsky
Hamilton
Ontario
More Hamilton Health Sciences Corporation trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
