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 investigates whether the supplement "Power Prenatal for Sperm" can improve sperm quality in men. The goal is to determine if taking this supplement for 90 days affects sperm count, movement, or shape in men experiencing infertility. Men with a recent semen analysis showing low sperm count, movement, or abnormal shape might be suitable candidates. Participants must not have a diagnosed varicocele or be currently taking antioxidant supplements. This study offers a potential option for enhancing fertility through dietary changes. As an unphased trial, it provides an opportunity to explore new dietary approaches to improving fertility.

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 prior data suggests that the Power Prenatal for Sperm is safe?

Research shows that specific safety information for Power Prenatal for Sperm is not yet available. Studies on similar products have produced mixed results. Some individuals experience no issues, while others might encounter mild side effects such as an upset stomach or headaches.

Power Prenatal for Sperm remains under testing, so clear safety evidence is not yet established. However, prenatal vitamins are generally safe for men. This does not guarantee they will meet all nutritional needs for improved sperm quality. Since everyone's body is different, consulting a healthcare provider before starting any new supplement is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for male infertility, which often involve hormonal therapies or invasive procedures, Power Prenatal for Sperm offers a non-invasive option with a novel approach. This supplement is unique because it combines targeted nutrients specifically formulated to improve sperm health, potentially increasing fertility. Researchers are excited about this treatment as it provides a more accessible, less intrusive solution that could enhance sperm quality over a relatively short period of three months.

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

Research has shown that supplements like Power Prenatal for Sperm, which contain vitamins and antioxidants, might improve sperm quality. In one study, antioxidant supplements improved sperm movement and shape by 52.6%. Another study found that antioxidants enhanced semen quality and increased pregnancy chances. However, not all research agrees; some studies found no strong evidence that supplements aid male infertility. While results are mixed, this trial continues to study the potential of Power Prenatal for Sperm to improve sperm quality. ^{1 2 6 7 8}

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. 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 ...

2. 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10135082/

Antioxidant Supplementation on Male Fertility—A ... The authors reported a 52.6% (362 cases) overall improvement in sperm motility, morphology, or both, and a percentage of 10.8% (75 cases) ...

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. mdpi.com mdpi.com/2072-6643/17/10/1710

The Effect of Dietary Supplements on Male Infertility in ... It has previously been suggested that dietary supplements improve male infertility. The current study, however, found no convincing evidence to support this ...

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. wenatal.com wenatal.com/blogs/wenatal/can-men-take-prenatal-vitamins?srsltid=AfmBOoqzmWRK7TnSHophBriFRq4k3XKenC5mphPhL2LVhjWJ5etyz1L4

Can Men Take Prenatal Vitamins? The short answer is yes, however, just because it's safe doesn't mean it is ideal to meet a man's nutrient needs when trying to conceive.

8. 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 ...