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Supplementation for Male Subfertility

NCT06091969 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-10-10

No results posted yet for this 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.

Conditions

  • Male Infertility

Interventions

DIETARY_SUPPLEMENT

Active multi-ingredient supplement (Fertility Enhancer, FE)

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

DIETARY_SUPPLEMENT

Inactive placebo (Placebo; PLA)

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

Sponsors & Collaborators

  • One Fertility

    collaborator OTHER

  • Hamilton Health Sciences Corporation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-02-02
Completion
2026-02-02

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06091969 on ClinicalTrials.gov