Supplementation for Male Subfertility

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age25-50
SponsorHamilton Health Sciences Corporation

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Smoking,

history and drug alcohol abuse,

BMI > 30 kg/m2,

genital disease (cryptorchidism, current genital inflammation, or varicocele),

Trial design

Treatments tested in this trial

  • Active multi-ingredient supplement (Fertility Enhancer, FE)
  • Inactive placebo (Placebo; PLA)

Treatment groups

64 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hamilton Health Sciences Corporation

Lead sponsor

McMaster University

Sponsor institution

One Fertility

Collaborator