A Clinical Trial to Evaluate the Effects of a Supplement on Markers of Male Fertility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Sperm Volume
研究概览
简要总结
This study will evaluate the effects of the WeNatal For Him supplement on markers of male fertility over a 3-month period. The trial is a single-arm, unblinded study enrolling 40 male participants who will take 3 capsules of the test product daily in the morning with their first meal.
Participants will complete questionnaires at Baseline, Month 1, Month 2, and Month 3. Semen analysis will be conducted at home at Baseline and Month 3, and blood testing will be performed at a local Labcorp location at Baseline and Month 3. The primary focus is on sperm quality parameters and testosterone levels, while secondary endpoints capture participants' perceptions of changes in reproductive and sexual health, including energy and libido.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be aged 30+
- •Anyone currently experiencing issues regarding low energy and low libido
- •Anyone who is generally healthy - does not live with any uncontrolled chronic disease
- •Willing to stop taking any other products or prescription medication, herbal remedies, or supplements for the duration of the study that target fertility, reproductive health, and sexual health
- •Not planning on introducing any products or any new prescription medication, herbal remedies, or supplements that target male fertility, reproductive health, or sexual health for the study duration
- •Resides in the United States
- •Not currently partaking in another research study and will not be partaking in any other research study for the next 3 months and at any point during this study's duration
- •Willing to provide a semen sample via masturbation
- •Willing to abstain from ejaculation for a minimum of 48 hours and a maximum of 5 days before providing the semen sample
- •Willing to abstain from marijuana products during the entire study duration
排除标准
- •Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- •Anyone who has ever taken supplemental testosterone
- •Anyone planning to undergo any surgeries or invasive treatments for the study duration
- •Anyone who has had a major illness in the last 3 months
- •Anyone currently undergoing any type of fertility treatment
- •Anyone with any allergies or sensitivities to any of the study product ingredients
- •Anyone unwilling to follow the study protocol
- •Anyone taking anticoagulant or 'blood thinner' medication
- •Anyone undergoing chemotherapy
- •Anyone taking insulin or diabetes medication
- •Anyone who drinks heavily (i.e. 8 or more alcoholic drinks per week for women or 15 or more alcoholic drinks per week for men)
- •Anyone with a history of substance abuse
- •Anyone who is currently a smoker or has been a smoker in the past 3 months
结局指标
主要结局
Change in Sperm Volume
时间窗: Baseline and Month 3
Assessed via at-home semen analysis using the Fellow Semen Analysis kit
Change in hs-CRP
时间窗: Baseline and Month 3
Assessed via blood test at a local Labcorp location
Change in Testosterone (Free and Total)
时间窗: Baseline and Month 3
Assessed via blood test at a local Labcorp location measuring free and total testosterone levels
Change in Sperm Concentration
时间窗: Baseline and Month 3
Assessed via at-home semen analysis using the Fellow Semen Analysis kit
Change in Sperm Count
时间窗: Baseline and Month 3
Assessed via at-home semen analysis using the Fellow Semen Analysis kit
Change in Sperm Motility
时间窗: Baseline and Month 3
Assessed via at-home semen analysis using the Fellow Semen Analysis kit
Change in Total Motile Count
时间窗: Baseline and Month 3
Assessed via at-home semen analysis using the Fellow Semen Analysis kit
Change in Sperm Morphology
时间窗: Baseline and Month 3
Assessed via at-home semen analysis using the Fellow Semen Analysis kit
Change in 25-hydroxy Vitamin D
时间窗: Baseline and Month 3
Assessed via blood test at a local Labcorp location
Change in Homocysteine
时间窗: Baseline and Month 3
Assessed via blood test at a local Labcorp location
次要结局
- Change in Self-Reported Reproductive Health(Baseline, Month 1, Month 2, and Month 3)
- Change in Self-Reported Energy(Baseline, Month 1, Month 2, and Month 3)
- Change in Self-Reported Libido(Baseline, Month 1, Month 2, and Month 3)