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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

Must not have

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

Genital trauma or surgery to the male reproductive system

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 3 months

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition affecting my genitals, such as undescended testicles, inflammation, or varicocele.

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I have had surgery or injury to my reproductive organs.

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I have severe kidney problems.

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I am currently taking medication to suppress my immune system.

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I am taking medication for seizures.

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I have had a brain or spinal cord injury.

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I am currently using hormone therapy for my condition.

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I am currently using or have used chemotherapy drugs.

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I have known genetic abnormalities in my Y chromosome.

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I have had a sexually transmitted infection recently or have one now.

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I have undergone chemotherapy for cancer in the past.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 study objectives

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

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.

0 / 11Eligibility criteria met