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
About this trial
This is an interventional treatment trial for Spermatogenesis and Semen Disorders
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
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
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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