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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04981275
• Other study ID #: HP-00089723
• Status: Completed
• Start date: June 19, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Onegevity Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: September 30, 2023
• Est. primary completion date: January 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• No intervention study
This observational study will only collect data, not provide any intervention to participants.

Locations

Country	Name	City	State
United States	University of Maryland	College Park	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Onegevity Health	University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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