Power Prenatal Vitamins for Male Infertility

Overseen By Dan Nayot, BSc, MSc, MD

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: The Bird and Be Co Inc

Must be taking: Prenatal vitamins

Disqualifiers: Active smokers, Known infertility, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 3 months

174 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the supplement "Power Prenatal for Sperm" can improve sperm quality in men facing infertility. Researchers seek to discover whether taking this supplement for 90 days can enhance sperm quality, as measured by an at-home test kit. Men who have used at-home sperm tests and received scores between 20-40, indicating some sperm mobility issues, might be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to explore potential improvements in sperm quality with a new supplement.

Do I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot take other forms of prenatal vitamins while participating.

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

The trial does not specify if you need to stop taking your current medications, but you cannot be taking other forms of prenatal vitamins while participating.

Is there any evidence suggesting that Power Prenatal for Sperm is likely to be safe for humans?

Research shows no specific safety information for Power Prenatal for Sperm. However, studies on similar supplements have produced mixed results. Some individuals notice positive effects, while others see little change.

These supplements typically contain vitamins, minerals, and antioxidants, which are generally safe for most people. Serious side effects are rare, but mild issues like an upset stomach or headaches might occur.

Since supplements aren't regulated as strictly as medicines, consulting a healthcare provider before starting any new supplement is advisable. This ensures safety based on personal health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for male infertility, such as hormone therapies or surgical interventions, Power Prenatal for Sperm focuses on enhancing sperm health through specific nutritional supplements. This treatment is unique because it incorporates a blend of active ingredients designed to improve sperm quality directly through diet. Researchers are excited about this approach as it offers a non-invasive option that could potentially enhance fertility without the need for medical procedures.

What evidence suggests that Power Prenatal for Sperm might be an effective treatment for male infertility?

Research suggests that supplements like Power Prenatal for Sperm might improve sperm quality. This supplement contains vitamins and antioxidants believed to support sperm health. Some studies have indicated that similar supplements can enhance sperm quality, though the evidence remains debated. These nutrients might increase sperm count and motility. However, results can vary, and effectiveness may depend on individual factors. Taking it for 90 days might help, but researchers are still studying definite results. ^{1 2 4 6 7}

Who Is on the Research Team?

Dan Nayot, BSc, MSc, MD

Principal Investigator

The Bird and Be Co Inc

Are You a Good Fit for This Trial?

This trial is for men aged 18-50 living in the USA or Canada who have a moderate level of sperm quality, as measured by an at-home YO Sperm test with scores between 20-40. It's aimed at those experiencing male infertility.

Inclusion Criteria

My at-home YO Sperm score is between 20-40.

Living in USA or Canada

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants receive Power Prenatal for Sperm supplements and evaluate YO Score monthly

3 months

3 visits (virtual)

Follow-up

Participants are monitored for changes in YO Score after treatment

1 month

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Power Prenatal for Sperm

Trial Overview The study tests if taking 'Power Prenatal for Sperm' supplements over a period of three months can improve sperm quality (YO Score) compared to standard laboratory and fatherhood benchmarks.

How Is the Trial Designed?

Group I: Power Prenatal for Sperm Experimental Treatment 1 Intervention

This is a single arm study. Participants will take supplements for 4 months. The supplements is Power Prenatal for Sperm (active ingredients - https://birdandbe.com/the-power-prenatal-for-sperm)

Who Is Running the Clinical Trial?

The Bird and Be Co Inc

Lead Sponsor

Trials

2

Recruited

220+

Published Research Related to This Trial

A vitamin B12-deficient diet during gestation and early development in rats led to significantly lower sperm counts and a higher incidence of abnormal sperm, indicating potential long-term effects on fertility.

Deficiency during pregnancy caused irreversible damage to germ cells, affecting sperm maturation, while no significant effects on sperm motility were observed in later stages of development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of dietary vitamin B12 deficiency on sperm maturation in developing and growing male rats. Watanabe, T., Ohkawa, K., Kasai, S., et al.[2019]

In a study of 274 men from Karachi, Pakistan, higher levels of vitamin B12, folic acid (FA), and methylmalonic acid (MMA) were associated with improved sperm parameters, including count, motility, and morphology, which are crucial for male fertility.

Specifically, for every 1 unit increase in these nutrients, the prevalence of infertility decreased by 1% for vitamin B12, 17% for folic acid, and a remarkable 74% for methylmalonic acid, highlighting their significant role in male reproductive health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Estimation of folic acid/micro nutrients levels; Does it reflect sperm parameters. Tariq, H., Zahid, N., Amir, D., et al.[2021]

Antioxidants have been shown to significantly improve live birth and pregnancy rates in men with infertility, with a Cochrane review indicating a 4.18 odds ratio for improved pregnancy rates and a 4.85-fold increase in live birth rates for those undergoing assisted reproduction.

Despite these promising results, further randomized controlled trials are necessary to confirm the safety and efficacy of antioxidant supplementation in treating male infertility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrient supplementation: improving male fertility fourfold. Mora-Esteves, C., Shin, D.[2013]

Antioxidant supplements, particularly combinations of vitamin C, vitamin E, and CoQ10, have been shown to significantly improve key semen parameters such as sperm count, motility, and morphology in men with infertility issues.

The study highlights that oxidative stress is a major contributor to male infertility, and that oral antioxidant supplementation can help mitigate this by enhancing the total antioxidant capacity of seminal fluid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antioxidant supplements and semen parameters: An evidence based review. Ahmadi, S., Bashiri, R., Ghadiri-Anari, A., et al.[2023]

Micronutrient supplementation may improve sperm concentration, motility, and morphology, which are important factors in male fertility, especially in cases of oxidative stress-related infertility.

Current evidence is mixed and suggests that while some micronutrients can be beneficial, a balanced diet is preferred over excessive supplementation, and more rigorous clinical trials are needed to establish effective protocols and safety for their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Effects of Micronutrient Supplements on Sperm Parameters: Fact or Fiction? Dimitriadis, F., Tsounapi, P., Zachariou, A., et al.[2021]

A review of randomized controlled studies over the last 30 years found that many over-the-counter vitamins and supplements may positively affect male fertility, particularly in improving semen parameters and pregnancy outcomes.

However, the study also highlighted significant variability in results, with some studies showing no improvement or potential complications, indicating a lack of standardization in dosing and treatment duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of over-the-counter supplements for the treatment of male infertility--fact or fiction? Ko, EY., Sabanegh, ES.[2013]

A study involving 78 men with idiopathic infertility showed that a combination of antioxidants significantly improved sperm quality and quantity over a 6-month treatment period.

After 3 months of treatment with Proxeed® Plus, improvements were observed in sperm concentration, total sperm count, and motility, indicating that antioxidant therapy can be beneficial for male fertility, although it requires a longer duration for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of 3- and 6-Month Outcomes of Combined Oral L-Carnitine Fumarate and Acetyl-L-Carnitine Therapy, Included in an Antioxidant Formulation, in Patients with Idiopathic Infertility. Szymański, M., Wandtke, T., Wasilow, K., et al.[2023]

A review of online information about male fertility vitamins revealed that many websites make unsubstantiated claims about improving sperm count and reproductive outcomes, with only 26 out of 100 sites supported by peer-reviewed literature.

Despite the claims, none of the supplements exceeded the upper tolerable intake levels for vitamins, although several contained amounts above the Recommended Daily Allowance, particularly for zinc, vitamin B12, and selenium.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discrepancies between the internet and academic literature regarding vitamin use for male infertility. Samplaski, MK., Clemesha, CG.[2022]

In a clinical trial involving 175 men with infertility issues, the supplement Proxeed Plus, which contains L-carnitine and L-acetylcarnitine, significantly improved sperm parameters such as volume, motility, and vitality after 6 months of treatment.

The study found that a decrease in sperm DNA fragmentation was a strong predictor of improved sperm motility, suggesting that addressing DNA integrity is crucial for enhancing male fertility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Double-blind, randomised, placebo-controlled trial on the effect of L-carnitine and L-acetylcarnitine on sperm parameters in men with idiopathic oligoasthenozoospermia. Micic, S., Lalic, N., Djordjevic, D., et al.[2023]

Supplementation with ascorbate during sperm preparation protects against hydrogen peroxide (H2O2)-induced DNA damage and reduces reactive oxygen species (ROS) generation, although it does not affect baseline DNA integrity.

Alpha-tocopherol also provides dose-dependent protection against H2O2-induced DNA damage and reduces ROS generation, but when combined with ascorbate, it can actually increase DNA damage, highlighting the importance of careful antioxidant selection in sperm preparation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of ascorbate and alpha-tocopherol supplementation in vitro on DNA integrity and hydrogen peroxide-induced DNA damage in human spermatozoa. Donnelly, ET., McClure, N., Lewis, SE.[2022]

A study of 347 Danish men whose mothers took folic acid supplements during pregnancy found no significant differences in semen quality compared to those whose mothers did not take supplements.

However, the group whose mothers took folic acid had higher serum levels of FSH and LH hormones, indicating a potential hormonal effect, but this did not translate to improved semen characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal folic acid supplement intake and semen quality in Danish sons: a follow-up study. Jacobsen, K., Ramlau-Hansen, CH., Thulstrup, AM., et al.[2015]

Citations

1. trialx.com trialx.com/clinical-trials/listings/296223/prospective-study-on-power-prenatal-vitamins-for-males-on-yo-score-at-home-sperm-test-results/

Prospective Study on Power Prenatal Vitamins for Males ... The effects of supplements (vitamins, minerals, and anti-oxidants) on improving sperm quality are still debated. Taking additional supplements ...

2. withpower.com withpower.com/trial/phase-infertility-7-2023-b349e

Power Prenatal Vitamins for Male Infertility Power Prenatal for Sperm, which includes vitamins and antioxidants, shows promise in improving sperm quality. Studies suggest that similar supplements can ...

3. clinconnect.io clinconnect.io/trials/NCT05410782

Power Prenatal Supplements for Sperm Quality - ClinConnect This clinical trial is studying whether a specific supplement called "Power Prenatal for Sperm" can improve sperm quality in men who are experiencing ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2839329

Antioxidant Treatment and the Chance to Conceive in Men ... This randomized clinical trial examines the effect of an antioxidant supplement on pregnancy outcomes and semen quality among men with ...

5. trial.medpath.com trial.medpath.com/clinical-trial/6d6c2f6a4dc7492a/nct05951075-impact-power-prenatal-supplements-males-yoscore-sperm-test

Prospective Study on Power Prenatal Vitamins for Males on ... The effects of supplements (vitamins, minerals, and anti-oxidants) on improving sperm quality are still debated. Taking additional supplements to improve sperm ...

6. withpower.com withpower.com/trial/phase-infertility-male-5-2022-974ff

Prenatal Supplements for Male Infertility The provided research does not directly address the safety data for prenatal supplements for male infertility, such as Power Prenatal for Sperm. The studies ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12113742/

The Effect of Dietary Supplements on Male Infertility in Terms ... This systematic review and meta-analysis found no evidence of an effect of dietary supplements on pregnancy and live birth rates in the limited ...