Health TrialsbyHealthPanel

Supplementation for Male Subfertility

ConditionMale Infertility
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Active multi-ingredient supplement (Fertility Enhancer, FE)

    Dietary supplement

    Consuming a multi-ingredient supplement targeting multiple cell pathways daily for 3 months.

  • Inactive placebo (Placebo; PLA)

    Dietary supplement

    Consuming an inactive placebo that is calorie-matched to the active supplement daily for 3 months.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Active multi-ingredient supplement (Fertility Enhancer; FE)Experimental treatment 1 intervention
Group B: Inactive placebo (Placebo; PLA)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent change in body composition index from baseline to 3 months

Lean mass/fat mass ratio by dual X-ray absorptiometry scan (body composition index; % change)

Time frame
Baseline to 3 months
2

Percent change in total fat mass from baseline to 3 months

Total fat mass by dual X-ray absorptiometry scan (kg; % change)

Time frame
Baseline to 3 months
3

Percent change in sperm count/concentration from baseline to 3 months

Sperm count/concentration (millions spermatozoa/mL semen)

Time frame
Baseline to 3 months
4

Percent change in sperm motility from baseline to 3 months

Proportion motile sperm (%)

Time frame
Baseline to 3 months

Secondary outcomes

1

Percent change in sperm DNA fragmentation index from baseline to 3 months

Sperm DNA fragmentation index by flow cytometry (%)

Time frame
Baseline to 3 months
2

Percent change in sperm DNA 8-hydroxydeoxyguanosine from baseline to 3 months

Sperm DNA 8-hydroxydeoxyguanosine by ELISA (ng/mL; %)

Time frame
Baseline to 3 months
3

Percent change in sperm protein carbonyls from baseline to 3 months

Sperm protein carbonyls immunoblot (optical density; %)

Time frame
Baseline to 3 months
4

Percent change in sperm lipid peroxidation (4-hydroxynonenal) from baseline to 3 months

Sperm 4-hydroxynonenal immunoblot (optical density; %)

Time frame
Baseline to 3 months

Other outcomes

1

Percent change in bodyweight from baseline to 3 months

Bodyweight by standard scale (kg; %)

Time frame
Baseline to 3 months
2

Percent change in body mass index from baseline to 3 months

Body mass index (BMI) (bodyweight/height squared; kg/m2; %)

Time frame
Baseline to 3 months
3

Percent change in lean mass from baseline to 3 months

Lean mass by dual X-ray absorptiometry scan (kg; %)

Time frame
Baseline to 3 months
4

Percent change in appendicular skeletal muscle mass from baseline to 3 months

Appendicular skeletal muscle mass by dual X-ray absorptiometry scan (kg; %)

Time frame
Baseline to 3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hamilton Health Sciences Corporation

Lead sponsor

McMaster University

Sponsor institution

One Fertility

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: