A Clinical Trial to Evaluate the Effects of a Supplement on Markers of Female 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 Anti-Müllerian Hormone (AMH)
研究概览
简要总结
This study evaluates the effects of a daily dietary supplement (WeNatal For Her) on markers of female fertility, reproductive health, and sexual health over three menstrual cycles. Forty female participants who are currently trying to conceive will take three capsules of the supplement each morning with their first meal.
The study is a single-arm, unblinded hybrid trial. Participants will complete questionnaires at Baseline and on Days 2-5 of Cycles 1, 2, and 3, and will attend a local Labcorp location for blood draws at Baseline and at Cycle 3. Primary outcomes include blood-based biomarkers of female fertility (e.g., AMH, FSH, Estradiol), while secondary outcomes capture self-reported perceptions of reproductive health, energy levels, mood, and overall well-being.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Be female.
- •Be aged 18-
- •In the past three menstrual cycles, has experienced issues with all of the following: Low energy levels and fatigue
- •Breast tenderness
- •Irritability or mood swings.
- •Currently trying to conceive.
- •Anyone who is generally healthy - does not live with any uncontrolled chronic disease.
- •Not planning on introducing any products or any new forms of prescription medication or supplements that target female fertility for the study duration.
- •Has a regular menstrual cycle between 21 and 35 days in length and is able to predict the dates of their upcoming periods.
- •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 three menstrual cycles and at any point during this study's duration.
- •Willing to avoid all other prenatal vitamins for the duration of this study.
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 with any allergies or sensitivities to any of the study product ingredients.
- •Any women who are currently pregnant or breastfeeding.
- •Anyone taking anticoagulant or "blood thinning" medication.
- •Anyone taking bisphosphonates or other prescription medications for osteoporosis.
- •Anyone taking chemotherapy medication.
- •Anyone diagnosed with hemochromatosis or elevated iron levels.
- •Anyone who drinks heavily (i.e. eight or more alcoholic drinks per week for women or 15 or more alcoholic drinks per week for men).
- •Anyone unwilling to follow the study protocol.
- •Anyone with a history of substance abuse.
- •Anyone who is currently a smoker or has been a smoker in the past three months.
- •Anyone who has stopped using hormonal birth control less than six months prior to starting the study.
- •Anyone previously diagnosed with premenstrual dysphoric disorder (PMDD), endometriosis, or any cancer of the reproductive system.
- •Anyone who is peri- or post-menopausal.
结局指标
主要结局
Change in Anti-Müllerian Hormone (AMH)
时间窗: Baseline and Day 2-5 of Cycle 3
Blood test measurement of serum AMH level to assess ovarian reserve
Change in Follicle-Stimulating Hormone (FSH)
时间窗: Baseline and Day 2-5 of Cycle 3
Blood test measurement of serum FSH level
Change in Estradiol
时间窗: Baseline and Day 2-5 of Cycle 3
Blood test measurement of serum Estradiol level
Change in Progesterone
时间窗: Baseline and Day 2-5 of Cycle 3
Blood test measurement of serum Progesterone level
Change in Testosterone
时间窗: Baseline and Day 2-5 of Cycle 3
Blood test measurement of serum Testosterone level
Change in 25-hydroxy Vitamin D
时间窗: Baseline and Day 2-5 of Cycle 3
Blood test measurement of serum 25-hydroxy Vitamin D level
Change in Serum Iron
时间窗: Baseline and Day 2-5 of Cycle 3
Blood test measurement of serum iron level
Change in Thyroid Stimulating Hormone (TSH)
时间窗: Baseline and Day 2-5 of Cycle 3
Blood test measurement of serum TSH level
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
时间窗: Baseline and Day 2-5 of Cycle 3
Blood test measurement of serum hs-CRP level
次要结局
- Change in Self-Reported Reproductive Health(Baseline, Day 2-5 of Cycle 1, Day 2-5 of Cycle 2, and Day 2-5 of Cycle 3)
- Change in Self-Reported Energy Levels(Baseline, Day 2-5 of Cycle 1, Day 2-5 of Cycle 2, and Day 2-5 of Cycle 3)
- Change in Self-Reported Mood(Baseline, Day 2-5 of Cycle 1, Day 2-5 of Cycle 2, and Day 2-5 of Cycle 3)
- Change in Self-Reported Breast Tenderness(Baseline, Day 2-5 of Cycle 1, Day 2-5 of Cycle 2, and Day 2-5 of Cycle 3)
- Change in Self-Reported Overall Well-Being(Baseline, Day 2-5 of Cycle 1, Day 2-5 of Cycle 2, and Day 2-5 of Cycle 3)