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OpenTrials
Completed

NCT Number: NCT04981275

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.

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Key information

Conditions

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

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Maryland

College Park, Maryland, 20742, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention study

Other

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

Primary outcomes

  1. Phenotype differences in vaginal microbiome

    Time frame: 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.

  2. Phenotype differences in gut microbiome

    Time frame: 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.

  3. Phenotype differences in blood biomarkers

    Time frame: 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.

  4. Phenotype differences in DNA

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Onegevity Health

Industry

Collaborators

  • University of Maryland, Baltimore

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jul 28, 2021
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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