A Multi-omic Approach to Evaluate and Characterize the Polycystic Ovary Syndrome (PCOS) Phenotype

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-omic Approach to Evaluate and Characterize the Polycystic Ovary Syndrome (PCOS) Phenotype

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Other: No intervention study


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with PCOS<br>Women previously diagnosed with PCOS not using hormonal therapy and without other significant health or endocrine issues | Other: No intervention study<br>* This observational study will only collect data, not provide any intervention to participants.<br>|
| Healthy controls<br>Women self-identifying as generally healthy, not using hormonal therapy, and without any significant health or endocrine issues | Other: No intervention study<br>* This observational study will only collect data, not provide any intervention to participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phenotype differences in vaginal microbiome | 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. | Samples to be collected on any day once per participant within 30 days of enrollment | 
| Phenotype differences in gut microbiome | 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. | Samples to be collected once on any day per participant within 30 days of enrollment | 
| Phenotype differences in blood biomarkers | 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. | Samples to be collected once within a 5-day window to control for menstrual cycle, within 30 days of enrollment | 
| Phenotype differences in DNA | 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. | Samples to be collected once per participant within 30 days of enrollment |