Female Infertility, Fertility, Hormonal Imbalance, Ovarian Reserve, Reproductive Health
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTWeNatal For Her Supplement
All 40 participants take three capsules of the WeNatal For Her supplement daily in the morning with their first meal for three menstrual cycles.
Sponsors
WeNatal
Citruslabs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Be female. * Be aged 18-45. * In the past three menstrual cycles, has experienced issues with all of the following: Low energy levels and fatigue * Bloating * 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anti-Müllerian Hormone (AMH) | 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) | Baseline and Day 2-5 of Cycle 3 | Blood test measurement of serum FSH level |
| Change in Estradiol | Baseline and Day 2-5 of Cycle 3 | Blood test measurement of serum Estradiol level |
| Change in Progesterone | Baseline and Day 2-5 of Cycle 3 | Blood test measurement of serum Progesterone level |
| Change in Testosterone | Baseline and Day 2-5 of Cycle 3 | Blood test measurement of serum Testosterone level |
| Change in 25-hydroxy Vitamin D | Baseline and Day 2-5 of Cycle 3 | Blood test measurement of serum 25-hydroxy Vitamin D level |
| Change in Serum Iron | Baseline and Day 2-5 of Cycle 3 | Blood test measurement of serum iron level |
| Change in Thyroid Stimulating Hormone (TSH) | Baseline and Day 2-5 of Cycle 3 | Blood test measurement of serum TSH level |
| Change in High-Sensitivity C-Reactive Protein (hs-CRP) | Baseline and Day 2-5 of Cycle 3 | Blood test measurement of serum hs-CRP level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Assessed via self-reported questionnaire measuring participant perceptions of reproductive health |
| 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 | Assessed via self-reported questionnaire measuring participant perceptions of energy levels |
| 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 | Assessed via self-reported questionnaire measuring participant perceptions of mood |
| 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 | Assessed via self-reported questionnaire measuring participant perceptions of breast tenderness |
| 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 | Assessed via self-reported questionnaire measuring participant perceptions of overall well-being |
Countries
United States
Outcome results
None listed