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Fertility Supplement for Male Infertility (FertEnhancer Trial)

Phase 2

Waitlist Available

Research Sponsored by Hamilton Health Sciences Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 3 months

Awards & highlights

FertEnhancer Trial Summary

This trial will test if a novel multi-ingredient supplement can improve male fertility by targeting age-related cell pathways.

Who is the study for?

Men aged 25-50 with diagnosed subfertility can join this trial. They must meet WHO criteria for sperm health but cannot have genital diseases, recent reproductive surgeries, or be using certain medications like immunosuppressants. Smokers and those with a BMI over 30 aren't eligible.Check my eligibility

What is being tested?

The study is testing a new multi-ingredient supplement (Fertility Enhancer) against a placebo to see if it improves sperm function in subfertile men by targeting oxidative stress and other age-related cell issues over three months.See study design

What are the potential side effects?

Potential side effects are not specified here, but supplements could cause allergic reactions, gastrointestinal discomfort or interact with other medications.

FertEnhancer Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent change in body composition index from baseline to 3 months

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

Percent change in sperm morphology from baseline to 3 months

+3 more

Secondary outcome measures

Percent change in sperm ATP levels from baseline to 3 months

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

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

+16 more

Other outcome measures

Percent change in ATP levels from baseline to 3 months

Percent change in Oxygen Radical Absorbance Levels (ORAC) from baseline to 3 months

Percent change in Trolox Equivalent Antioxidant Capacity (TEAC) from baseline to 3 months

+14 more

FertEnhancer Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active multi-ingredient supplement (Fertility Enhancer; FE)Experimental Treatment1 Intervention

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.

Group II: Inactive placebo (Placebo; PLA)Placebo Group1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

One FertilityOTHER

3 Previous Clinical Trials

530 Total Patients Enrolled

Hamilton Health Sciences CorporationLead Sponsor

368 Previous Clinical Trials

300,929 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age cutoff for this research project end at 70 years of age?

"This particular study mandates that potential enrollees must be between 25 and 50 years old. For those outside this age range, there are 17 clinical trials designed for minors and 37 medical studies catering to seniors above the age of 65."

Answered by AI

Is Fertility Enhancer (FE) a risk-free option for individuals?

"Even though there is not yet any clinical data to suggest its efficacy, the safety of Active multi-ingredient supplement (Fertility Enhancer; FE) was rated a 2 due to prior studies confirming that it is secure for use."

Answered by AI

Would I be eligible to join this medical experiment?

"For eligibility in this trial, male infertility sufferers between 25 and 50 years of age are being sought to fill a total of 64 vacancies."

Answered by AI

Are physicians actively seeking participants for this trial?

"According to information on clinicaltrials.gov, this trial is not open for patient recruitment at present; the listing was first posted in February 2024 and last updated October 2023. Yet presently 262 other studies are seeking participants."

Answered by AI

What are the main goals this clinical trial is attempting to accomplish?

"This investigation, which will span from Baseline to 3 months, is trying to quantify the alteration in sperm motility over this period. Secondary indices of success include calculating semen 8-hydroxydeoxyguanosine (ng/mL) by ELISA, assessing protein carbonyls immunoblot optical density, and lastly measuring 4-hydroxynonenal immunoblot optical density for lipid peroxidation variance."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Supplementation for Male Subfertility

Mark Tarnopolsky 2024. "Supplementation for Male Subfertility". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06091969.

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