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

Onegevity Health81 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Polycystic Ovary Syndrome

Interventions

No intervention studyOTHER

This observational study will only collect data, not provide any intervention to participants.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Maryland

College Park, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Samples to be collected once per participant within 30 days of enrollment

Data from ClinicalTrials.gov

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