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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-19

Study Completion Date

2023-09-30

Brief Summary

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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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Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with PCOS

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

No intervention study

Intervention Type OTHER

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

No intervention study

Intervention Type OTHER

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

Interventions

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No intervention study

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes