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

Onegevity

Status: Completed

Conditions: Polycystic Ovary Syndrome

Treatments: Other: No intervention study

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04981275

HP-00089723

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

81 participants in 2 patient groups

Women with PCOS

Description:

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

Treatment:

Other: No intervention study

Healthy controls

Description:

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

Treatment:

Other: No intervention study