Power Prenatal Supplements for Sperm Quality

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility, Male; Spermatogenesis and Semen Disorders
• Intervention / Treatment: Dietary supplement: Power Prenatal for Sperm

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dan Nayot, Bsc, MSc, MD; Phone Number: 4166163334; Email: dan@birdandbe.com

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L5N 5S3
      • Recruiting
      • Reproductive Care Centre
      • Contact: Dan Nayot, BSc, MSc, MD; Phone Number: 2403 905-816-9822; Email: dnayot@rccfertility.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

  1. Low concentration: < 15 Million / mL
  2. Low Motility: Progessive Motility < 30%
  3. Morphology: Strict criteria: Normal forms < 4% Reference: WHO 2020 6th edition: https://www.who.int/publications/i/item/9789240030787

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Power Prenatal for Sperm; 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; A prenatal vitamin complex that includes numerous ingredients aim at improving sperm quality (ingredients: https://birdandbe.com/the-power-prenatal-for-sperm); Other Names: Prenatal Vitamins

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sperm Concentration (Semen Analysis); as millions / mL	Semen analysis	A repeat semen analysis will be performed 3 months after Power Prenatal for Sperm intervention
Sperm Morphology (Semen Analysis); as percentage (%)	Semen Analysis	A repeat semen analysis will be performed 3 months after Power Prenatal for Sperm intervention

Collaborators and Investigators

• Sponsor: The Bird and Be Co Inc
• Investigators: Principal Investigator: Dan Nayot, BSc, MSc, MD, The Bird and Be Co

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: June 5, 2022
• First Submitted That Met QC Criteria: June 5, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 20, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Infertility; Infertility, Male; Physiological Effects of Drugs; Micronutrients; Vitamins
• Other Study ID Numbers: Power Prenatal for Sperm

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No