Prospective Study on Power Prenatal Vitamins for Males on YO Score At-home Sperm Test Results

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

174 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Male patients that used the FDA approved YO Sperm at-home sperm analysis kit, and were identified with a low YO Score result (20-40) will be potential candidates for this study.

An automated message about a potential research study for patients with a low YO Score results (20-40) will be sent to YO Sperm users. Interested participants will sign up to learn more about the research study. They will be prompted to complete further screening questions to ensure they're eligible study candidates (including inclusion and exclusion criteria, as well as primary residence country and province / state).

All study participants will be provided with IRB-approved study information materials and informed consent documents.

Once approved, and consented to participate, they will receive 3 months of The Power Prenatal for Males (https://birdandbe.com/collections/male-fertility/products/power-prenatal-vitamins-for-males) and re-evaluate the YO Score results monthly for 3 consecutive months after starting the supplements.

The monthly YO Scores will be compared between baseline, month 1, month 2 and month 3. YO Sperm's app will enable study participants to share results (YO Score) with the research team at each assessment. All data will be stored by the study sponsor in a secure and private manner compliant with HIPAA.

Conditions

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Spermatogenesis and Semen Disorders Infertility, Male

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Male patients that used the FDA approved YO Sperm at-home sperm analysis kit, and were identified with low YO Score results (20-40) will be recruited to take a 3 month course of supplements (Power Prenatal for Sperm), and a monthly YO Score at-home sperm test will be performed monthly for 3 consecutive months after starting the supplements.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Power Prenatal for Sperm

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)

Group Type EXPERIMENTAL

Power Prenatal for Sperm

Intervention Type DIETARY_SUPPLEMENT

A prenatal vitamin complex that includes numerous ingredients aim at improving sperm quality (ingredients: https://birdandbe.com/the-power-prenatal-for-sperm

Interventions

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Power Prenatal for Sperm

A prenatal vitamin complex that includes numerous ingredients aim at improving sperm quality (ingredients: https://birdandbe.com/the-power-prenatal-for-sperm

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Prenatal Vitamin

Eligibility Criteria

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Inclusion Criteria

* Male patients with at-home YO Sperm score between 20-40, corresponding to a MSC (motile sperm concentration) between 14-39 motile million / ml
* Ages 18-50
* Living in USA or Canada

Exclusion Criteria

* Active smokers
* A known cause of male infertility (eg diagnosed varicocele, hormonal issue, history of testicular surgery, history of chemotherapy, etc)
* Not concurrently taking other forms of prenatal vitamins

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes