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

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 Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Other: No intervention study

• Study Type: Observational
• Enrollment (Actual): 81

Contacts and Locations

Study Locations

• United States
  • Maryland
    • College Park, Maryland, United States, 20742
      • University of Maryland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Women, ages 18-40, living in the USA (except for NY, NJ, RI, MD, SD, ND, or HI), who have not been using hormonal therapy for at least 3 months and without other significant health issues or medications affecting hormones. Women must be previously diagnosed with PCOS or considered Healthy and not currently pregnant or nursing. Women will be referred to the study by their Physician or word of mouth.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Onegevity Health
• Collaborators: University of Maryland, Baltimore
• Investigators: Principal Investigator: Chris D'Adamo, PhD, University of Maryland; Principal Investigator: Chris Mason, PhD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2021
• Primary Completion (Actual): January 11, 2022
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: HP-00089723

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No