Fertility Supplement for Male Infertility
(FertEnhancer Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a new supplement, Fertility Enhancer, can improve sperm function in overweight or obese men who have difficulty getting their partners pregnant. The supplement combines ingredients like amino acids, vitamins, and antioxidants to address issues related to aging, such as cellular stress and energy use. Participants will take either the supplement or a placebo (a non-active look-alike) for three months. Men diagnosed with subfertility and struggling with obesity might be suitable candidates for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important fertility research.
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.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that male fertility supplements can have mixed results. Some studies found that after 90 days of taking these supplements, men with low sperm count and movement saw improvements. Specifically, their sperm count doubled, and their sperm movement increased by 1.5 times, suggesting the supplements might help some men.
However, not all studies agree. One study found that a mix of antioxidant supplements did not improve pregnancy rates or semen quality, indicating that the effectiveness of these supplements can vary.
Regarding safety, one review suggests that using preconception supplements without knowing the right dose can be harmful. In experiments with mice, excessive amounts of certain nutrients damaged sperm DNA. Therefore, while some ingredients in fertility supplements may help, using the right amount is crucial to avoid potential harm.12345Why do researchers think this study treatment might be promising?
Researchers are excited about the Fertility Enhancer (FE) supplement because it offers a novel approach to tackling male infertility. Unlike standard treatments like hormone therapy or surgery, this supplement combines multiple active ingredients that are specifically designed to enhance sperm quality and count. This multi-ingredient formula targets sperm health more comprehensively, potentially providing a less invasive and more holistic alternative to traditional methods. The convenience of a daily oral supplement also makes it an appealing option for those seeking non-invasive solutions.
What evidence suggests that this treatment might be an effective treatment for male infertility?
Research has shown that certain supplements can improve male fertility. A review of 29 studies found that antioxidant supplements positively affected sperm quality, leading to better results in assisted reproductive therapy (ART) and higher live-birth rates. Other studies have discovered that ingredients like amino acids, vitamins, and trace minerals can improve sperm movement and count. For instance, one study showed a supplement increased sperm movement from 23.17% to 31.11%. In this trial, the Fertility Enhancer, which participants may receive, combines several of these ingredients to reduce oxidative stress and boost cell energy, potentially enhancing sperm function. These findings suggest that using these supplements together could improve fertility in men with subfertility issues.34678
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily supplementation of either the Fertility Enhancer or placebo for 3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Fertility Enhancer
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
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.
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
One Fertility
Collaborator
Citations
Antioxidant Supplementation on Male Fertility—A ...
29 studies found a substantial positive effect of AS on outcomes of assisted reproductive therapy (ART), WHO semen parameters, and live-birth rate.
Systematic Review and Critical Analysis on Dietary ...
A systematic review of literature identified ingredients potentially effective on sperm parameters and their minimal effective daily dose (mED).
Male Fertility Supplements: Evidence Based Review ...
In this study, the percentage of motile sperm improved from 23.17% to 31.11% and the percentage of forward progressive sperm went from 14.83% to ...
The association of medications and supplements with ...
CCBs cause reversible male infertility and inhibit the expression of mannose-ligand binding receptors, which causes fertilization failure in IVF.
What Supplements Are Best for Male Fertility?
In one study, 400 mg daily improved sperm quality more than 200 mg daily. Another study found improved sperm motility, sperm count, and sperm ...
The Role of Dietary Nutrients in Male Infertility: A Review
Observations have indicated that adding DN may protect or treat male infertility. The scope of this criticism is to scrutinize the DN, such as ...
Antioxidant Treatment and the Chance to Conceive in Men ...
Treatment of men seeking fertility care with the combined antioxidant supplement did not improve pregnancy outcomes, semen parameters, ...
The dual nature of micronutrients on fertility: too much of a ...
The findings in healthy mice suggest that indiscriminate use of preconception supplements with inappropriate doses of micronutrients may harm sperm DNA and ...
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