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临床试验/NCT05410782
NCT05410782招募中不适用

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

The Bird and Be Co Inc2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
2
主要终点
Sperm Progressive Motility (Semen Analysis); as percentage (%)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

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

Semen analysis

次要结局

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

研究者

发起方
The Bird and Be Co Inc
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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