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

April 5, 2025 updated by: The Bird and Be Co Inc

The Impact of Power Prenatal Supplements for Males on YO Score At-home Sperm Test Results Over a Three Month Course

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Encino, California, United States, 91390
        • Recruiting
        • Medical Electronic Systems
        • Contact:
          • Dan Nayot, BSc, MSc, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Dietary supplement: 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
Other Names:
  • Prenatal Vitamin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
YO Sperm Score
Time Frame: The YO Scores will be compared between baseline (prior to intervention) and after 3 months
At-home YO Sperm score (10-90) YO Score is a ranking of a participants motile sperm concentration (MSC) compared to other men who have fathered children. The result is 10 to 90 in intervals of 10. A score of10 represents the lowest score (participant ranks above 10% of fathers), and 90 the highest score (participant ranks above 90% of fathers). The higher your YO Score, the more likely you are to achieve a pregnancy in a shorter amount of time. YO Score is a reliable tool for monitoring MSC changes over time
The YO Scores will be compared between baseline (prior to intervention) and after 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Bird and Be Co Inc

Investigators

  • Principal Investigator: Dan Nayot, BSc, MSc, MD, The Bird and Be Co Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 25, 2023

First Submitted That Met QC Criteria

July 11, 2023

First Posted (Actual)

July 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 8, 2025

Last Update Submitted That Met QC Criteria

April 5, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BirdandBe

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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