Supplementation for Male Subfertility

NCT06091969 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 16502
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Male Infertility

Keywords

Sub-fertility; Infertility; Antioxidants; Supplements; Creatine; Arginine; Vitamins; Aging; Oxidative stress; Inflammation; DNA; Mitochondria; Fragmentation; ATP; Weight loss; Obesity

Outcome Measures

Primary Outcomes (6)

• 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)

  Baseline to 3 months

• Percent change in total fat mass from baseline to 3 months

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

  Baseline to 3 months

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

  Sperm count/concentration (millions spermatozoa/mL semen)

  Baseline to 3 months

• Percent change in sperm motility from baseline to 3 months

  Proportion motile sperm (%)

  Baseline to 3 months

• Percent change in sperm morphology from baseline to 3 months

  Proportion normal sperm morphology (%)

  Baseline to 3 months

• Percent change in sperm vitality from baseline to 3 months

  Proportion viable sperm (vitality) (%)

  Baseline to 3 months

Secondary Outcomes (19)

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

  Baseline to 3 months

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

  Baseline to 3 months

• Percent change in sperm protein carbonyls from baseline to 3 months

  Baseline to 3 months

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

  Baseline to 3 months

• Percent change in sperm antioxidant marker superoxide dismutase 1 from baseline to 3 months

  Baseline to 3 months

Other Outcomes (17)

• Percent change in bodyweight from baseline to 3 months

  Baseline to 3 months

• Percent change in body mass index from baseline to 3 months

  Baseline to 3 months

• Percent change in lean mass from baseline to 3 months

  Baseline to 3 months

Study Arms (2)

Active multi-ingredient supplement (Fertility Enhancer; FE)

EXPERIMENTAL

Volunteers will be randomized in a double-blinded fashion into the experimental treatment group, which entails daily supplementation of an active multi-ingredient supplement designed to enhance fertility (Fertility Enhancer; FE) for 3 months.

Dietary Supplement: Active multi-ingredient supplement (Fertility Enhancer, FE)

Inactive placebo (Placebo; PLA)

PLACEBO COMPARATOR

Volunteers will be randomized in a double-blinded fashion into a placebo group, which entails daily supplementation of a calorie-matched, inactive placebo (Placebo; PLA) identical in flavor to the active supplement for 3 months.

Dietary Supplement: Inactive placebo (Placebo; PLA)

Interventions

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

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

Active multi-ingredient supplement (Fertility Enhancer; FE)

Inactive placebo (Placebo; PLA) DIETARY_SUPPLEMENT

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

Inactive placebo (Placebo; PLA)

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• One Fertility: collaborator

Study Sites (1)

Mark Tarnopololsky

Hamilton, Ontario, L8N 3Z5, Canada

Location

MeSH Terms

Conditions

Infertility, Male; Infertility; Inflammation; Weight Loss; Obesity

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Body Weight; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Mark A Tarnopolsky, PhD

CONTACT

9055212100; tarnopol@mcmaster.ca

Mats Nilsson

CONTACT

9055212100; mats.nilsson@exerkine.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Volunteers will be given an identifier number and then randomized into placebo or active groups by an independent third party meaning that all participants, care providers and investigators will be blinded to the treatment allocations until the end of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a 3-month placebo-controlled, double-blinded, randomized clinical trial comparing an active supplement designed to enhance sperm function (Fertility Enhancer) to an inactive placebo (PLACEBO) in overweight or obese and subfertile males.

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: October 23, 2023
• Study Start: January 1, 2025
• Primary Completion: February 2, 2026
• Study Completion: February 2, 2026
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The study protocol, informed consent form and statistical analysis plan may be made available from February 2025 onward. This may occur along with the release of the deidentified results for publishing requirements and/or upon request by qualified researchers.
• Access Criteria: Access to trial data can be requested by qualified researchers engaging in independent scientific research studies.

Locations

CA (1)