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

Trial Summary

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.

What data supports the idea that Power Prenatal Vitamins for Male Infertility is an effective treatment?

The available research shows mixed results regarding the effectiveness of Power Prenatal Vitamins for Male Infertility. Some studies suggest that over-the-counter supplements, including antioxidants, can improve semen quality and increase pregnancy rates. For example, one study found that men taking antioxidants had a significant increase in live birth and pregnancy rates. However, other studies indicate no consistent improvement and highlight potential complications. Overall, there is no definitive conclusion about the effectiveness of these vitamins for male infertility, and more research is needed. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Power Prenatal for Sperm in improving male infertility?

Some studies suggest that antioxidants, which are often found in prenatal vitamins, can improve semen quality and increase pregnancy and live birth rates. However, results are mixed, and more research is needed to confirm these findings. ^{1 2 3 4 5}

What safety data exists for Power Prenatal Vitamins for Male Infertility?

The research provided does not directly address the safety data for Power Prenatal Vitamins for Male Infertility or its variants. However, it includes studies on the effects of vitamin B12 deficiency on sperm maturation, the impact of micronutrients on sperm parameters, and the role of antioxidants like ascorbate and alpha-tocopherol on sperm DNA integrity. Additionally, a review of over-the-counter supplements for male infertility highlights both positive effects and potential complications, but notes a lack of standard dosing regimens and definitive conclusions. Therefore, specific safety data for Power Prenatal Vitamins is not available in the provided research. ^{3 6 7 8 9}

Is Power Prenatal Vitamins for Male Infertility safe for humans?

There is no specific safety data available for Power Prenatal Vitamins for Male Infertility, but studies on similar supplements show mixed results, with some indicating potential benefits and others suggesting possible complications. It's important to consult with a healthcare provider before starting any new supplement. ^{3 6 7 8 9}

Is Power Prenatal for Sperm a promising treatment for male infertility?

Power Prenatal for Sperm, which includes vitamins and antioxidants, shows promise in improving sperm quality. Studies suggest that similar supplements can enhance sperm count, movement, and shape, which are important for fertility. However, results can vary, and more research is needed to confirm its effectiveness. ^{1 3 5 10 11}

How is the treatment Power Prenatal for Sperm different from other treatments for male infertility?

Power Prenatal for Sperm is unique because it focuses on using a combination of vitamins and antioxidants to improve sperm quality, addressing oxidative stress, which is a common cause of male infertility. Unlike some treatments that may not have standardized dosing, this approach uses specific nutrients known to enhance sperm parameters, such as motility and count. ^{1 3 5 10 11}

What is the purpose of this trial?

Male factor infertility is a leading cause of primary and secondary infertility. Poor sperm quality is defined as having an abnormal semen analysis. There are now options to assess sperm quality with at-home sperm analysis kits, including an FDA approved Yo Sperm kit (https://yospermtest.com/) which analyzes the motile sperm concentration \[concentration (millions / ml) x motility (Percentage motile)\] and sperm quality (YO Score) which compares your results to laboratory standards and to other men who have fathered children. The effects of supplements (vitamins, minerals, and anti-oxidants) on improving sperm quality are still debated. Taking additional supplements to improve sperm quality represent a modifiable risk-factor that would be an easy intervention for patients struggling with male factor infertility. The life cycle of sperm production is estimated at 3 months, so any intervention would require a 3 month course to see its full effect. The investigators hypothesize that a 90 day course of the "Power Prenatal for Sperm", a male fertility supplement by Bird\&Be (https://birdandbe.com/the-power-prenatal-for-sperm) will improve sperm quality (YO Score) after taking the supplements.

Research Team

Dan Nayot, BSc, MSc, MD

Principal Investigator

The Bird and Be Co Inc

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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 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]

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]

References

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Therapeutic Effects of Micronutrient Supplements on Sperm Parameters: Fact or Fiction? [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Maternal folic acid supplement intake and semen quality in Danish sons: a follow-up study. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

The role of over-the-counter supplements for the treatment of male infertility--fact or fiction? [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Nutrient supplementation: improving male fertility fourfold. [2013]

5. China pubmed.ncbi.nlm.nih.gov

Discrepancies between the internet and academic literature regarding vitamin use for male infertility. [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

The effects of dietary vitamin B12 deficiency on sperm maturation in developing and growing male rats. [2019]

7. India pubmed.ncbi.nlm.nih.gov

Estimation of folic acid/micro nutrients levels; Does it reflect sperm parameters. [2021]

8. Germany 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. [2023]

9. England 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. [2022]

10. United States 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. [2023]

11. Iran pubmed.ncbi.nlm.nih.gov

Antioxidant supplements and semen parameters: An evidence based review. [2023]