64 Participants Needed

Fertility Supplement for Male Infertility

(FertEnhancer Trial)

MA
MN
Overseen ByMats Nilsson
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of 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.

Do I need to stop taking my current medications for the trial?

You may need to stop taking certain supplements that contain the ingredients being tested, but only after a 1-month period without them. The protocol does not specify stopping other medications, but some exclusions apply, such as cytotoxic drugs, immunosuppressants, and certain other medications.

What data supports the effectiveness of the treatment Fertility Enhancer for male infertility?

Research shows that dietary supplements, which may include ingredients like zinc and coenzyme Q10, can improve sperm concentration and testosterone levels in men with infertility. However, the effectiveness of these supplements can vary depending on the specific ingredients and their doses.12345

Is the fertility supplement for male infertility safe for humans?

Research on similar supplements, like antioxidants for male infertility, shows they are generally safe and well-tolerated, with no reported adverse events in studies.12678

How is the Fertility Enhancer treatment different from other treatments for male infertility?

Fertility Enhancer is unique because it is a dietary supplement that combines various nutrients, potentially improving sperm parameters. Unlike some treatments that may not have proven efficacy, this supplement focuses on ingredients like zinc, selenium, and coenzyme Q, which have shown potential benefits, although the effectiveness of such supplements is still debated.1291011

Eligibility Criteria

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.

Inclusion Criteria

For diagnosis of male subfertility, the 2010 and 2021 World Health Organization standards will be applied to sperm count, motility, morphology and vitality.
I am a man aged 25-50 diagnosed with subfertility by ONE Fertility.

Exclusion Criteria

You are a smoker.
You have a history of substance abuse or excessive alcohol consumption.
I have a condition affecting my genitals, such as undescended testicles, inflammation, or varicocele.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily supplementation of either the Fertility Enhancer or placebo for 3 months

12 weeks
Monthly visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

Treatment Details

Interventions

  • Fertility Enhancer
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hamilton Health Sciences Corporation

Lead Sponsor

Trials
380
Recruited
345,000+

One Fertility

Collaborator

Trials
4
Recruited
590+

References

Dietary Supplements for Male Infertility: A Critical Evaluation of Their Composition. [2021]
Systematic Review and Critical Analysis on Dietary Supplements for Male Infertility: From a Blend of Ingredients to a Rationale Strategy. [2022]
Effectiveness of Pharmacological Intervention Among Men with Infertility: A Systematic Review and Network Meta-Analysis. [2023]
Dietary supplementation with a novel l-carnitine multi-micronutrient in idiopathic male subfertility involving oligo-, astheno-, teratozoospermia: A randomized clinical study. [2021]
Quantifying the effectiveness and cost-efficiency of food supplementation with antioxidants for male infertility. [2011]
Use of a male antioxidant nutraceutical is associated with superior live birth rates during IVF treatment. [2021]
7.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Assessment of the safety and efficacy of medicinal product PPR-001 based on regulatory polypeptides of the testes]. [2022]
Impact of antioxidants in improving semen parameters like count, motility and DNA fragmentation in sub-fertile males: a randomized, double-blind, placebo-controlled clinical trial. [2023]
[Clinical observation and study of mechanisms of needle-picking therapy for primary infertility of abnormal sperm]. [2006]
10.United Statespubmed.ncbi.nlm.nih.gov
Application of a ready-to-use calcium ionophore increases rates of fertilization and pregnancy in severe male factor infertility. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Systematic review of antioxidant types and doses in male infertility: Benefits on semen parameters, advanced sperm function, assisted reproduction and live-birth rate. [2022]