Spermatogenesis and Semen DisordersNCT05951075
Prospective Study on Power Prenatal Vitamins for Males on YO Score At-home Sperm Test Results
A study testing Power Prenatal for Sperm in people with Spermatogenesis and Semen Disorders and Infertility, Male, run by The Bird and Be Co Inc at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Spermatogenesis and Semen Disorders, Infertility, Male
- What is being tested?
- Power Prenatal for Sperm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical Electronic Systems
Encino, California, 91390
Dan Nayot, BSc, MSc, MD
About this study
Official title: The Impact of Power Prenatal Supplements for Males on YO Score At-home Sperm Test Results Over a Three Month Course
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.
Read more
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.
Read the 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.
- Being tested
- Power Prenatal for Sperm
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power Prenatal for SpermDietary supplement
Also called Prenatal Vitamin
A prenatal vitamin complex that includes numerous ingredients aim at improving sperm quality (ingredients: https://birdandbe.com/the-power-prenatal-for-sperm
| Study group | Role | What they receive |
|---|---|---|
| Power Prenatal for Sperm | Experimental | 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) Receives: Dietary Supplement: Power Prenatal for Sperm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The YO Scores will be compared between baseline (prior to intervention) and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spermatogenesis and Semen DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Bird and Be Co Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Nayot, BSc, MSc, MD, Principal investigator, The Bird and Be Co Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951075
- Sponsor's protocol ID
- BirdandBe
- Status last verified
- Aug 2024
- First submitted
- 25 Jun 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30462179
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Power Prenatal Supplements for Males on YO Score At-home Sperm Test Results Over a Three Month Course
- ClinicalTrials.gov ID
- NCT05951075
- Acronym / sponsor ID
- BirdandBe
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- The Bird and Be Co IncIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Power Prenatal for Sperm | Experimental | Dietary Supplement: Power Prenatal for SpermThis 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) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Power Prenatal for SpermAlso: Prenatal VitaminA prenatal vitamin complex that includes numerous ingredients aim at improving sperm quality (ingredients: https://birdandbe.com/the-power-prenatal-for-sperm | Dietary supplement | Power Prenatal for Sperm |
Primary outcome
YO Sperm Score
Time frame: The YO Scores will be compared between baseline (prior to intervention) and after 3 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Background: PubMed 30462179Salas-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.
- WHO laboratory manual for the examination and processing of human semenLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Spermatogenesis and Semen Disorders
Recruiting
Power Prenatal Supplements for Sperm Quality
Spermatogenesis and Semen Disorders, Infertility, Male
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dan Nayot, BSc, MSc, MD principal investigator
The Bird and Be Co Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Power Prenatal for Sperm in people with Spermatogenesis and Semen Disorders and Infertility, Male, run by The Bird and Be Co Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Nayot, BSc, MSc, MD (14166163334, dan@birdandbe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
YO Sperm Score (time frame: The YO Scores will be compared between baseline (prior to intervention) and after 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05951075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.