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

NCT04981275 | Completed

• 1 other identifier: HP-00089723
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Women with PCOS

Women previously diagnosed with PCOS not using hormonal therapy and without other significant health or endocrine issues

Other: No intervention study

Healthy controls

Women self-identifying as generally healthy, not using hormonal therapy, and without any significant health or endocrine issues

Other: No intervention study

Interventions

No intervention study OTHER

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

Healthy controls; Women with PCOS

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Women diagnosed with PCOS or Women who are considered Healthy
• years old
• Have not been using hormonal therapy for at least 3 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Onegevity Health: lead
• University of Maryland, Baltimore: collaborator

Study Sites (1)

University of Maryland

College Park, Maryland, 20742, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, saliva, vaginal microbiome, stool microbiome

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Chris D'Adamo, PhD

  University of Maryland

  PRINCIPAL INVESTIGATOR

• Chris Mason, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 28, 2021
• Study Start: June 19, 2021
• Primary Completion: January 11, 2022
• Study Completion: September 30, 2023
• Last Updated: November 1, 2023

Record last verified: 2023-10

Locations

US (1)