Polycystic Ovary Syndrome
Conditions
Brief summary
The purpose of this research study is to explore the relationship between the gut microbiome and hormone levels in women diagnosed with PCOS and determine whether there are differences in the gut microbiome between women with PCOS and women without PCOS. Consented, enrolled participants will complete a health questionnaire, complete a fasted blood draw at a local laboratory, and provide a stool, saliva, and vaginal swab sample for comprehensive biomarkers, hormones, metagenomics, and metabolomics analysis.
Interventions
This observational study will only collect data, not provide any intervention to participants.
Sponsors
University of Maryland, Baltimore
Onegevity Health
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Women diagnosed with PCOS or Women who are considered Healthy * 18-40 years old * Residing in the USA, except for exclusion states * Have not been using hormonal therapy for at least 3 months
Exclusion criteria
* Women using hormonal therapy within the last 3 months * Diagnosed with other significant health conditions or using medications that will affect hormone levels * Residing in NY, NJ, MD, RI, ND, SD, or HI * Pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phenotype differences in vaginal microbiome | Samples to be collected on any day once per participant within 30 days of enrollment | Understand phenotypical differences from biological samples comparing women with and without PCOS. Vaginal swabs are to be collected by women and analyzed with metagenomics and metabolomics sequencing. |
| Phenotype differences in gut microbiome | Samples to be collected once on any day per participant within 30 days of enrollment | Understand phenotypical differences from biological samples comparing women with and without PCOS. Stool samples are to be collected by women and analyzed with metagenomics sequencing. |
| Phenotype differences in blood biomarkers | Samples to be collected once within a 5-day window to control for menstrual cycle, within 30 days of enrollment | Understand phenotypical differences from biological samples comparing women with and without PCOS. Venipuncture blood draws are to be completed and analyzed by a commercial laboratory, for a comprehensive analysis of targeted hormones and untargeted metabolic systems. |
| Phenotype differences in DNA | Samples to be collected once per participant within 30 days of enrollment | Understand phenotypical differences from biological samples comparing women with and without PCOS. Saliva samples are to be collected and analyzed by a commercial laboratory for DNA and metabolomics. |
Countries
United States
Outcome results
None listed