Power Prenatal Supplements for Sperm Quality

NCT05410782 | Recruiting

• 1 other identifier: Power Prenatal for Sperm
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 \[WHO 2020 - https://www.who.int/publications/i/item/9789240030787\]. 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.

Conditions

Spermatogenesis and Semen Disorders; Infertility, Male

Outcome Measures

Primary Outcomes (1)

• Sperm Progressive Motility (Semen Analysis); as percentage (%)

  Semen analysis

  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

  A repeat semen analysis will be performed 3 months after Power Prenatal for Sperm intervention

• Sperm Morphology (Semen Analysis); as percentage (%)

  A repeat semen analysis will be performed 3 months after Power Prenatal for Sperm intervention

Study Arms (1)

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)

Dietary Supplement: Power Prenatal for Sperm

Interventions

Power Prenatal for Sperm DIETARY_SUPPLEMENT

A prenatal vitamin complex that includes numerous ingredients aim at improving sperm quality (ingredients: https://birdandbe.com/the-power-prenatal-for-sperm)

Also known as: Prenatal Vitamins

Power Prenatal for Sperm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Bird and Be Co Inc: lead

Study Sites (1)

Reproductive Care Centre

Mississauga, Ontario, L5N 5S3, Canada

RECRUITING

MeSH Terms

Conditions

Infertility, Male

Interventions

Sperm Count; Prenatal Care

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Semen Analysis; Investigative Techniques; Cell Physiological Phenomena; Patient Care; Therapeutics; Maternal Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Dan Nayot, BSc, MSc, MD

  The Bird and Be Co

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Nayot, Bsc, MSc, MD

CONTACT

4166163334; dan@birdandbe.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 5, 2022
• First Posted: June 8, 2022
• Study Start: November 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 8, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)