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

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Other: No intervention study

• Registration Number: NCT04981275
• Lead Sponsor: Onegevity Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-19
• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-07-28
• Primary Completion: 2022-01-11
• Study Completion: 2023-09-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	No intervention study	Women self-identifying as generally healthy, not using hormonal therapy, and without any significant health or endocrine issues
Women with PCOS	No intervention study	Women previously diagnosed with PCOS not using hormonal therapy and without other significant health or endocrine issues

Primary Outcome Measures

Name	Time	Method
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.
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 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.

Trial Locations

Locations (1)

University of Maryland; 🇺🇸 College Park, Maryland, United States