Power Prenatal Supplements for Sperm Quality

Infertility, Male Clinical Trial

Official title:

A Three Month Course of Power Prenatal Supplements to Improve Sperm Quality in Male-factor Infertility Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05410782
• Other study ID #: Power Prenatal for Sperm
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: The Bird and Be Co Inc
• Contact: Dan Nayot, Bsc, MSc, MD
• Phone: 4166163334
• Email: dan[@]birdandbe.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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]. 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.

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/exami nation-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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Spermatogenesis and Semen Disorders

Intervention

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)

Locations

Country	Name	City	State
Canada	Reproductive Care Centre	Mississauga	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Bird and Be Co Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sperm Concentration (Semen Analysis); as millions / mL	Semen analysis	A repeat semen analysis will be performed 3 months after Power Prenatal for Sperm intervention
Secondary	Sperm Morphology (Semen Analysis); as percentage (%)	Semen Analysis	A repeat semen analysis will be performed 3 months after Power Prenatal for Sperm intervention