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

Infertility, Male Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Spermatogenesis and Semen Disorders

• NCT number: NCT05951075
• Study type: Interventional
• Source: The Bird and Be Co Inc
• Contact: Dan Nayot, BSc, MSc, MD
• Phone: 14166163334
• Email: dan@birdandbe.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Completion date: June 30, 2024