Prospective Study on Power Prenatal Vitamins for Males on YO Score At-home Sperm Test Results
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Power Prenatal for Sperm.
- Who it may be relevant to
- Registry conditions: Spermatogenesis and Semen Disorders, Infertility, Male. Basic parameters: 18 years — 50 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Impact of Power Prenatal Supplements for Males on YO Score At-home Sperm Test Results Over a Three Month Course
Overview
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.
Interventions
- 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
Primary outcome measures
- YO Sperm Score [Time frame: The YO Scores will be compared between baseline (prior to intervention) and after 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Medical Electronic Systems — Encino
Publications
- 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. PMID 30462179
Identifiers
NCT: NCT05951075 · BirdandBe