Clinical trial NCT05951075: 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
Overall status: RECRUITING
Phase: NA
Conditions: Spermatogenesis and Semen Disorders
Infertility, Male
Lead sponsor: The Bird and Be Co Inc
Sponsor class: INDUSTRY
First posted: 2023-07-18
Enrollment: 174
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: YO Sperm Score
timeFrame: The YO Scores will be compared between baseline (prior to intervention) and after 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Encino
country: United States
facility: Medical Electronic Systems
state: California
Study officials:
affiliation: The Bird and Be Co Inc
name: Dan Nayot, BSc, MSc, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.