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

Primary Purpose

Spermatogenesis and Semen Disorders, Infertility, Male

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Power Prenatal for Sperm
Sponsored by
The Bird and Be Co Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spermatogenesis and Semen Disorders

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Power Prenatal for Sperm

    Arm Description

    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)

    Outcomes

    Primary Outcome Measures

    YO Sperm Score
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 25, 2023
    Last Updated
    July 11, 2023
    Sponsor
    The Bird and Be Co Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05951075
    Brief Title
    Prospective Study on Power Prenatal Vitamins for Males on YO Score At-home Sperm Test Results
    Official Title
    The Impact of Power Prenatal Supplements for Males on YO Score At-home Sperm Test Results Over a Three Month Course
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2024 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The Bird and Be Co Inc

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spermatogenesis and Semen Disorders, Infertility, Male

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    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.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    174 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Power Prenatal for Sperm
    Arm Type
    Experimental
    Arm Description
    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)
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Power Prenatal for Sperm
    Other Intervention Name(s)
    Prenatal Vitamin
    Intervention Description
    A prenatal vitamin complex that includes numerous ingredients aim at improving sperm quality (ingredients: https://birdandbe.com/the-power-prenatal-for-sperm
    Primary Outcome Measure Information:
    Title
    YO Sperm Score
    Description
    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
    Time Frame
    The YO Scores will be compared between baseline (prior to intervention) and after 3 months

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    Focus on sperm quality
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dan Nayot, BSc, MSc, MD
    Phone
    14166163334
    Email
    dan@birdandbe.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dan Nayot, BSc, MSc, MD
    Organizational Affiliation
    The Bird and Be Co Inc
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30462179
    Citation
    Salas-Huetos A, Rosique-Esteban N, Becerra-Tomas N, Vizmanos B, Bullo M, Salas-Salvado J. The Effect of Nutrients and Dietary Supplements on Sperm Quality Parameters: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Adv Nutr. 2018 Nov 1;9(6):833-848. doi: 10.1093/advances/nmy057.
    Results Reference
    background
    Links:
    URL
    https://www.who.int/publications/i/item/9789240030787
    Description
    WHO laboratory manual for the examination and processing of human semen

    Learn more about this trial

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

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