Spermatogenesis and Semen DisordersNCT05410782
Power Prenatal Supplements for Sperm Quality
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 Canada.
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 [WHO 2020 - https://www.who.int/publications/i/item/9789240030787]. Read more about this study
- Who is it for?
- Ages 18 to 45 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
- 50 participants
- Where
- 1 siteCanada
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Age 18-45 years old
- Experiencing infertility
- A recent semen analysis confirming low count, motility or morphology (at least 1 of 3) - within last 3 months
- Low concentration: < 15 Million / mL
- Low Motility: Progessive Motility < 30%
- Morphology: Strict criteria: Normal forms < 4% Reference: WHO 2020 6th edition: https://www.who.int/publications/i/item/9789240030787
Who cannot join
- No diagnosed varicocele
- Younger than 18 years old
- Older than 45 years old
- Currently taking any form of antioxidant supplements(in last 3 months) besides a general multivitamin
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Reproductive Care Centre
Mississauga, Ontario, L5N 5S3
Dan Nayot, BSc, MSc, MD, 905-816-9822 ext. 2403, dnayot@rccfertility.com
About this study
Official title: A Three Month Course of Power Prenatal Supplements to Improve Sperm Quality in Male-factor Infertility Patients
Male factor infertility is a leading cause of primary and secondary infertility. Poor sperm quality is defined as having an abnormal semen analysis [WHO 2020 - https://www.who.int/publications/i/item/9789240030787]. The effects of supplements (vitamins, minerals, and anti-oxidants) on improving sperm quality are still debated (https://pubmed.ncbi.nlm.nih.gov/30462179). 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 based on semen analysis results prior to, and after taking the supplements.
Read the detailed description
Male patients presenting to Conceive Health (https://conceivehealth.com/) or Reproductive Care Centre for infertility care will be potential candidates for this study. Male patients that have had a recent abnormal semen analysis conforming at least 1 of 3 parameters (low concentration: < 15 Million / mL; low progressive motility < 30%, and low morphology with strict criteria < 4%) will be eligible to participate.
Patients will be approached by a study coordinator to participate in the study. The study coordinator will ensure all inclusion and exclusion criteria is met, consents forms are signed, and a 90 day course of the "Power Prenatal for Sperm" is dispensed
Study participants will be instructed to repeat a semen analysis (at the same lab) after their 90 day course of the "Power Prenatal for Sperm". The differences between the semen analysis parameters will be compared
The primary outcome was chosen as processive motility, as this parameter is mostly likely to be positively impacted by the Power Prenatal for Sperm.
An abnormal progressive motility is defined as <5th percentile (32%) of the semen analysis of the fertile male population. The standard deviation for this population is 13.5%. The estimated effect size is 37.5%, from 32% to 44%, an increase of 12%. The alpha (type 1 error) significant level was set at 5% and the power level was set at 80%. The required sample size was 40 patients. Given that this study requires a 3 month intervention prior to a follow up semen analysis for comparison, the investigators estimated a 20% drop-out rate, so the total requirement was set at 50 patients.
Table A1.2 (https://www.who.int/docs/default-source/reproductive-health/srhr-documents/infertility/examination-and-processing-of-human-semen-5ed-eng.pdf)
Statistical analyses will be performed using standard expected methods. All data will be presented as mean ± Standard Deviation (SD). Statistical significance between semen analysis data will be determined by using the Shapiro-Wilk test of normality for predictions and paired samples t-test.
- 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 Vitamins
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 3 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.
Sperm Progressive Motility (Semen Analysis); as percentage (%)
Semen analysis
Measured: A repeat semen analysis will be performed 3 months after Power Prenatal for Sperm intervention
Secondary outcomes (2)
Sperm Concentration (Semen Analysis); as millions / mL
Semen analysis
Measured: A repeat semen analysis will be performed 3 months after Power Prenatal for Sperm intervention
Sperm Morphology (Semen Analysis); as percentage (%)
Semen Analysis
Measured: A repeat semen analysis will be performed 3 months after Power Prenatal for Sperm intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- 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.
- 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
- Patients with male factor infertility, who have a document abnormal semen analysis (at least 1 of 3 abnormal parameters - concentration, progressive motility or morphology) will be recruited to take a 3 month course of supplements (Power Prenatal for Sperm), and a repeat semen analysis will be performed after the intervention to compare results
- Masking
- None (open label)
- Enrolment
- 50 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410782
- Sponsor's protocol ID
- Power Prenatal for Sperm
- Status last verified
- Aug 2024
- First submitted
- 5 Jun 2022
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- A Three Month Course of Power Prenatal Supplements to Improve Sperm Quality in Male-factor Infertility Patients
- ClinicalTrials.gov ID
- NCT05410782
- Acronym / sponsor ID
- Power Prenatal for Sperm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 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
- 8 Jun 2022 (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 [WHO 2020 - https://www.who.int/publications/i/item/9789240030787]. The effects of supplements (vitamins, minerals, and anti-oxidants) on improving sperm quality are still debated (https://pubmed.ncbi.nlm.nih.gov/30462179). 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 based on semen analysis results prior to, and after taking the supplements.
Detailed description
Male patients presenting to Conceive Health (https://conceivehealth.com/) or Reproductive Care Centre for infertility care will be potential candidates for this study. Male patients that have had a recent abnormal semen analysis conforming at least 1 of 3 parameters (low concentration: < 15 Million / mL; low progressive motility < 30%, and low morphology with strict criteria < 4%) will be eligible to participate.
Patients will be approached by a study coordinator to participate in the study. The study coordinator will ensure all inclusion and exclusion criteria is met, consents forms are signed, and a 90 day course of the "Power Prenatal for Sperm" is dispensed
Study participants will be instructed to repeat a semen analysis (at the same lab) after their 90 day course of the "Power Prenatal for Sperm". The differences between the semen analysis parameters will be compared
The primary outcome was chosen as processive motility, as this parameter is mostly likely to be positively impacted by the Power Prenatal for Sperm.
An abnormal progressive motility is defined as <5th percentile (32%) of the semen analysis of the fertile male population. The standard deviation for this population is 13.5%. The estimated effect size is 37.5%, from 32% to 44%, an increase of 12%. The alpha (type 1 error) significant level was set at 5% and the power level was set at 80%. The required sample size was 40 patients. Given that this study requires a 3 month intervention prior to a follow up semen analysis for comparison, the investigators estimated a 20% drop-out rate, so the total requirement was set at 50 patients.
Table A1.2 (https://www.who.int/docs/default-source/reproductive-health/srhr-documents/infertility/examination-and-processing-of-human-semen-5ed-eng.pdf)
Statistical analyses will be performed using standard expected methods. All data will be presented as mean ± Standard Deviation (SD). Statistical significance between semen analysis data will be determined by using the Shapiro-Wilk test of normality for predictions and paired samples t-test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with male factor infertility, who have a document abnormal semen analysis (at least 1 of 3 abnormal parameters - concentration, progressive motility or morphology) will be recruited to take a 3 month course of supplements (Power Prenatal for Sperm), and a repeat semen analysis will be performed after the intervention to compare results
| Arm | Type | Receives |
|---|---|---|
| Power Prenatal for Sperm | Experimental | Dietary Supplement: Power Prenatal for SpermThis is a single arm study. Participants will take supplements for 3 months. The supplements is Power Prenatal for Sperm (active ingredients - https://birdandbe.com/the-power-prenatal-for-sperm) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male
- Age 18-45 years old
- Experiencing infertility
- A recent semen analysis confirming low count, motility or morphology (at least 1 of 3) - within last 3 months
Key exclusion criteria (4 listed)
- No diagnosed varicocele
- Younger than 18 years old
- Older than 45 years old
- Currently taking any form of antioxidant supplements(in last 3 months) besides a general multivitamin
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 VitaminsA 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
Sperm Progressive Motility (Semen Analysis); as percentage (%)
Time frame: A repeat semen analysis will be performed 3 months after Power Prenatal for Sperm intervention
Semen analysis
2 secondary outcomes
Sperm Concentration (Semen Analysis); as millions / mL
Time frame: A repeat semen analysis will be performed 3 months after Power Prenatal for Sperm intervention
Sperm Morphology (Semen Analysis); as percentage (%)
Time frame: A repeat semen analysis will be performed 3 months after Power Prenatal for Sperm intervention
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.
- Individual participant dataSharing planned: No
Related trials for Spermatogenesis and Semen Disorders
Recruiting
Prospective Study on Power Prenatal Vitamins for Males on YO Score At-home Sperm Test Results
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
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 Canada.
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 7 inclusion and 4 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 Canada. 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 (4166163334, dan@birdandbe.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm Progressive Motility (Semen Analysis); as percentage (%) (time frame: A repeat semen analysis will be performed 3 months after Power Prenatal for Sperm intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.