Recruiting

Observational Study

Sponsor:

The Cleveland Clinic

Code:

NCT07571915

Conditions

PCOS (Polycystic Ovary Syndrome)

Eligibility Criteria

Sex: Female

Age: 18 - 49

Healthy Volunteers: Accepted

Interventions

Intervention Group

Study Details

Brief summary:

The primary outcome of interest is change in PCOS health-related quality of life, while the secondary outcome of interest is change in adiposity, cardiometabolic, and inflammation biomarkers.

Conditions

PCOS (Polycystic Ovary Syndrome)

Study ID

NCT07571915

Start date

Jun 1, 2026

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 49

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Non-pregnant females ages 18-49 years
2. Preexisting diagnoses of PCOS and obesity (body-mass index (BMI) equal or greater to 30 kg/m2) at enrollment

Exclusion Criteria:

1. Patients who are pregnant or planning to become pregnant during the study period
2. Patients currently or with recent participation (< 12 months at the time of enrollment) in a PCOS-focused group
3. Patients with documented monogenic obesity
4. Patients with a diagnosis of any type of diabetes (with the exclusion of prediabetes)
5. Patients on systemic glucocorticoid therapy > 7 days at the time of enrollment
6. Patients with any end-stage organ disease
7. Patients without access to internet
8. Patients requiring English language interpretation
9. Any condition which, based on the investigator's medical judgment, would preclude patient ability to complete the study

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Standard of Care

Participants will complete seca mBCA (medical Body Composition Analyzer), lab workup, and questionaries

experimental: Intervention Group

Participants will complete a seca mBCA (medical Body Composition Analyzer), lab workup, and questionaries

Short term comprehensive PCOS education coupled with lifestyle modification support

Interventions

Intervention Group

Short term comprehensive PCOS education coupled with lifestyle modification support

Primary outcome measure

  • Difference in Modified PCOS Health-related Quality of life questionnaire (mPCOSQ) scoring between participants. [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-13. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-07-01.