Prenatal Supplements 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 not be taking: Antioxidant supplements

Disqualifiers: Varicocele, Age, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if a few months of taking the 'Power Prenatal for Sperm' supplement can improve sperm quality in men with infertility issues. The supplement contains nutrients that may help improve sperm concentration, movement, and shape.

Do I have to stop taking my current medications?

The trial requires that you stop taking any antioxidant supplements, except for a general multivitamin, if you have taken them in the last 3 months.

Will I have to stop taking my current medications?

The trial requires that you stop taking any antioxidant supplements, except for a general multivitamin, for at least 3 months before participating.

What safety data exists for 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 focus on hormonal male contraception and other unrelated treatments, but do not provide specific safety data for the prenatal supplements in question. ^{1 2 3 4 5}

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

Power Prenatal for Sperm, like other supplements, may help improve sperm health and increase the chances of pregnancy. Some studies show positive effects on sperm quality and fertility outcomes, suggesting it could be a promising treatment for male infertility. ^{6 7 8 9 10}

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 prenatal supplements, which are typically associated with female health, to address male infertility. This approach is novel as it combines various vitamins and antioxidants, which may help improve sperm quality by reducing oxidative stress, a common issue in male infertility. ^{6 7 8 9 10}

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

The available research shows mixed results regarding the effectiveness of Prenatal Supplements for Male Infertility. Some studies suggest that over-the-counter supplements can improve semen quality and pregnancy outcomes, but other studies show no improvement and even potential complications. There is no clear standard for how these supplements should be used, making it difficult to draw definitive conclusions about their effectiveness. Compared to other treatments like physical exercise, which also shows inconsistent results, the effectiveness of these supplements remains uncertain. ^{6 11 12 13 14}

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

Some studies show that over-the-counter supplements can have positive effects on semen quality and pregnancy outcomes, but results are mixed and not conclusive. There is no standard dosing or definitive evidence for their effectiveness in treating male infertility. ^{6 11 12 13 14}

Who Is on the Research Team?

Dan Nayot, BSc, MSc, MD

Principal Investigator

The Bird and Be Co

Are You a Good Fit for This Trial?

Men aged 18-45 with recent poor sperm quality (low count, motility, or morphology) and experiencing infertility can join this trial. They must not have a varicocele, be taking antioxidants other than multivitamins, or be outside the age range.

Inclusion Criteria

Morphology: Strict criteria: Normal forms < 4% Reference: WHO 2020 6th edition: https://www.who.int/publications/i/item/9789240030787

Male

A recent semen analysis confirming low count, motility or morphology (at least 1 of 3) - within last 3 months

Exclusion Criteria

Older than 45 years old

You don't have a diagnosed condition called varicocele, which affects the veins in the testicles.

You are currently taking any antioxidant supplements, except for a basic multivitamin, within the past three months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 90-day course of the 'Power Prenatal for Sperm' supplement

12 weeks

1 visit (in-person) for initial assessment and supplement dispensing

Follow-up

Participants are monitored for changes in sperm quality through a repeat semen analysis

4 weeks

1 visit (in-person) for semen analysis

What Are the Treatments Tested in This Trial?

Interventions

• Power Prenatal for Sperm

Trial Overview The trial is testing 'Power Prenatal for Sperm', a supplement aimed at improving sperm quality over a 90-day course. Participants' semen will be analyzed before and after to assess any changes in sperm health.

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 3 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 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 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 study of 1,054 men with nonobstructive azoospermia, preoperative testosterone levels did not significantly impact sperm retrieval rates during microdissection testicular sperm extraction, with rates of 56% for those with testosterone above 300 ng/dl and 52% for those below.

Hormonal therapy effectively increased testosterone levels in men with low baseline levels, but this increase did not correlate with improved sperm retrieval, clinical pregnancy, or live birth rates, suggesting that optimizing testosterone may not enhance reproductive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of optimizing testosterone before microdissection testicular sperm extraction in men with nonobstructive azoospermia. Reifsnyder, JE., Ramasamy, R., Husseini, J., et al.[2022]

Microsurgical fertilization techniques are advancing the treatment of male factor infertility, enabling assisted conception for couples who previously could not benefit from in-vitro fertilization, although these methods are still underutilized among subfertile men.

Pharmacological treatments and sperm selection methods remain common approaches for enhancing sperm motility and fertilizing ability in subfertile men, with various compounds being explored for their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological stimulation of sperm motility. Lanzafame, F., Chapman, MG., Guglielmino, A., et al.[2019]

This systematic review aims to evaluate the effects of exercise on semen quality and reproductive outcomes in male infertility patients by analyzing randomized controlled trials (RCTs), ensuring a comprehensive assessment of existing literature.

The study will assess key reproductive metrics such as live-birth rates, sperm concentration, and motility, providing evidence-based insights into the efficacy and safety of physical exercise as a treatment for male infertility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of physical exercises on semen quality and reproductive outcomes in male infertility: A protocol for systematic review and meta-analysis of randomized controlled trials. Yan, X., Dong, L., Liu, Y., et al.[2023]

In a study of 41 men with infertility issues, a 5-day treatment with clomiphene citrate significantly improved seminal vesicle function, which in turn reduced the prevalence of high sperm chromatin stability from 67% to 25%.

The research found that higher levels of seminal fructose and serum testosterone were associated with a lower likelihood of high sperm chromatin stability, suggesting that these factors may play a role in the effectiveness of clomiphene citrate treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of clomiphene citrate in the treatment of men with high sperm chromatin stability. Gonzales, GF., Salirrosas, A., Torres, D., et al.[2019]

Male sheep exposed to excess prenatal testosterone showed significant reproductive health issues, including reduced body weight, scrotal circumference, and sperm count compared to control males, indicating that prenatal testosterone can disrupt male reproductive development.

Despite the reproductive disruptions, the testosterone response to human chorionic gonadotropin was similar between the testosterone-exposed males and controls, suggesting that the negative effects on sperm quality and quantity are not due to differences in testosterone production.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prenatal testosterone excess reduces sperm count and motility. Recabarren, SE., Rojas-García, PP., Recabarren, MP., et al.[2013]

In a study involving adult male Sprague-Dawley rats, oral administration of NP at varying doses (40, 100, or 250 mg/kg) over 90 days resulted in structural and functional damage to the testis.

The treatment also induced apoptosis and oxidative stress in the epididymis and exhibited cytotoxic effects on epididymal sperm, indicating potential reproductive toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

90d Exposure to Nonylphenol has Adverse Effects on the Spermatogenesis and Sperm Maturation of Adult Male Rats. Lu, WC., Wang, AQ., Chen, XL., et al.[2018]

Hormonal male contraception can effectively suppress gonadotrophins to achieve reversible azoospermia or severe oligozoospermia, with clinical trials showing high contraceptive efficacy and few side effects, similar to female hormonal contraceptives.

New combination regimens of synthetic progestins and androgens are being developed, with promising results leading to upcoming phase III trials, indicating a strong potential for new male contraceptive options in family planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hormonal approaches to male contraception: approaching reality. Wu, FC.[2006]

In a study involving 23 men with normal sperm counts and 18 men with subnormal sperm counts, testosterone injections effectively suppressed sperm production in both groups, with about 72% of men with subnormal counts achieving sperm levels below 1 million/ejaculate.

Both groups demonstrated full reversibility of sperm counts to baseline levels after a recovery period, indicating that hormonal male contraception is effective and safe for men regardless of their initial semen parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hormonal male contraception in men with normal and subnormal semen parameters. Nieschlag, E., Vorona, E., Wenk, M., et al.[2011]

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]

Medical therapies for male subfertility include stimulating sperm production and improving sperm transport, with the most success seen in cases of hormonal issues and blockages in the reproductive tract.

Advanced techniques like intracytoplasmic sperm injection (ICSI) and sperm collection methods (MESA and TESE) have significantly improved treatment options for severe male infertility, allowing for better planning and use of cryopreserved sperm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapy of male subfertility]. Schill, WB., Köhn, FM.[2006]

Oxidative stress negatively impacts sperm health and is a common issue in infertile men, leading to the consideration of antioxidant supplements as a potential treatment, although caution is advised based on recent reviews.

Survey data indicates that a significant number of men prefer medical treatments aimed at achieving natural conception over assisted reproductive technologies, with many willing to participate in clinical trials to explore these options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Male infertility and antioxidants: one small step for man, no giant leap for andrology? Martins da Silva, SJ.[2020]

In a study of 114 infertile men with idiopathic astenoteratozoospermia, a daily supplement containing various antioxidants significantly improved sperm progressive motility from 18.3% to 42.1% over 4 months.

The treatment was well tolerated, and 16 patients achieved pregnancy, indicating that this nutritional supplement complex may enhance sperm quality and fertility in affected individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective open-label study on the efficacy and tolerability of a combination of nutritional supplements in primary infertile patients with idiopathic astenoteratozoospermia. Busetto, GM., Koverech, A., Messano, M., et al.[2016]

Citations

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

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

2. China pubmed.ncbi.nlm.nih.gov

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

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

Role of optimizing testosterone before microdissection testicular sperm extraction in men with nonobstructive azoospermia. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Pharmacological stimulation of sperm motility. [2019]

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

Effects of physical exercises on semen quality and reproductive outcomes in male infertility: A protocol for systematic review and meta-analysis of randomized controlled trials. [2023]

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

Use of clomiphene citrate in the treatment of men with high sperm chromatin stability. [2019]

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

Prenatal testosterone excess reduces sperm count and motility. [2013]

8. China pubmed.ncbi.nlm.nih.gov

90d Exposure to Nonylphenol has Adverse Effects on the Spermatogenesis and Sperm Maturation of Adult Male Rats. [2018]

9. Ireland pubmed.ncbi.nlm.nih.gov

Hormonal approaches to male contraception: approaching reality. [2006]

10. England pubmed.ncbi.nlm.nih.gov

Hormonal male contraception in men with normal and subnormal semen parameters. [2011]

11. 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]

12. Austria pubmed.ncbi.nlm.nih.gov

[Therapy of male subfertility]. [2006]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Male infertility and antioxidants: one small step for man, no giant leap for andrology? [2020]

14. Italy pubmed.ncbi.nlm.nih.gov

Prospective open-label study on the efficacy and tolerability of a combination of nutritional supplements in primary infertile patients with idiopathic astenoteratozoospermia. [2016]