PCOS (Polycystic Ovary Syndrome)NCT07571915
Health-Related Quality of Life and Metabolic Outcomes in PCOS
A study testing Intervention Group in people with PCOS (Polycystic Ovary Syndrome), run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome)
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-pregnant females ages 18-49 years
- Preexisting diagnoses of PCOS and obesity (body-mass index (BMI) equal or greater to 30 kg/m2) at enrollment
Who cannot join
- Patients who are pregnant or planning to become pregnant during the study period
- Patients currently or with recent participation (< 12 months at the time of enrollment) in a PCOS-focused group
- Patients with documented monogenic obesity
- Patients with a diagnosis of any type of diabetes (with the exclusion of prediabetes)
- Patients on systemic glucocorticoid therapy > 7 days at the time of enrollment
- Patients with any end-stage organ disease
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- Patients without access to internet
- Patients requiring English language interpretation
- Any condition which, based on the investigator's medical judgment, would preclude patient ability to complete the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health-Related Quality of Life and Metabolic Outcomes in PCOS: A Feasibility Study of Comprehensive PCOS Education and Lifestyle Modification Support Delivered Via Synchronous Virtual Groups
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.
Read the detailed description
The proposed feasibility study seeks to test a short-term intervention focused on comprehensive PCOS (Polycystic Ovarian Syndrome) education and lifestyle modification support. The intervention, which will utilize an evidence-based PCOS curriculum, will be implemented by a multidisciplinary team of health providers via synchronous virtual group format.
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Being tested
- Intervention Group
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupOther
Short term comprehensive PCOS education coupled with lifestyle modification support
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Participants will complete seca mBCA (medical Body Composition Analyzer), lab workup, and questionaries |
| Intervention Group | Experimental | Participants will complete a seca mBCA (medical Body Composition Analyzer), lab workup, and questionaries
Short term comprehensive PCOS education coupled with lifestyle modification support Receives: Other: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Modified PCOS Health-related Quality of life questionnaire (mPCOSQ) scoring between participants.
Change in Polycystic ovarian Syndrome (PCOS) health-related quality of life assessed via the Modified PCOS Health-Related Quality of Life questionnaire (mPCOSQ) at two months and four months from baseline among intervention arm participants compared to controls.
Scale Range: The instrument uses a 7-point scale, where lower scores (e.g., 1) represent a high negative impact on quality of life, and higher scores (e.g., 7) represent better quality of life.
Measured: 4 months
Secondary outcomes (3)
Change in body composition analysis
Change in body composition analysis via seca mBCA (medical Body Composition Analyzer) at four months from baseline among intervention arm participants compared to controls.
Measured: 4 months
Change in visceral adiposity index (VAI)
Change in visceral adiposity index (VAI) via at four months from baseline among intervention arm participants compared to controls.
A reliable indicator of visceral fat function associated with cardiometabolic risk.
Sex-specific index, based on waist circumference, BMI, triglycerides, and HDL cholesterol, indirectly expressing visceral fat function.
Measured: 4 months
Change in fasting glucose, fasting insulin, c-reactive protein (CRP) at four months from baseline among intervention arm participants compared to controls.
Change in fasting glucose, fasting insulin, c-reactive protein (CRP) at four months from baseline among intervention arm participants compared to controls.
Fasting glucose units - mg/dL Fasting insulin units - mU/mL C-reactive protein - mg/L
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Jun 2026
- Primary completion1 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome)Studies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Family Physicians
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571915
- Sponsor's protocol ID
- 26-396
- Status last verified
- Oct 2026
- First submitted
- 23 Apr 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-Related Quality of Life and Metabolic Outcomes in PCOS: A Feasibility Study of Comprehensive PCOS Education and Lifestyle Modification Support Delivered Via Synchronous Virtual Groups
- ClinicalTrials.gov ID
- NCT07571915
- Acronym / sponsor ID
- 26-396
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- American Academy of Family Physicians
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The proposed feasibility study seeks to test a short-term intervention focused on comprehensive PCOS (Polycystic Ovarian Syndrome) education and lifestyle modification support. The intervention, which will utilize an evidence-based PCOS curriculum, will be implemented by a multidisciplinary team of health providers via synchronous virtual group format.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Participants will complete seca mBCA (medical Body Composition Analyzer), lab workup, and questionaries |
| Intervention Group | Experimental | Other: Intervention GroupParticipants will complete a seca mBCA (medical Body Composition Analyzer), lab workup, and questionaries Short term comprehensive PCOS education coupled with lifestyle modification support |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Non-pregnant females ages 18-49 years
- Preexisting diagnoses of PCOS and obesity (body-mass index (BMI) equal or greater to 30 kg/m2) at enrollment
Key exclusion criteria (9 listed)
- Patients who are pregnant or planning to become pregnant during the study period
- Patients currently or with recent participation (< 12 months at the time of enrollment) in a PCOS-focused group
- Patients with documented monogenic obesity
- Patients with a diagnosis of any type of diabetes (with the exclusion of prediabetes)
- Patients on systemic glucocorticoid therapy > 7 days at the time of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupShort term comprehensive PCOS education coupled with lifestyle modification support | Other | Intervention Group |
Primary outcome
Difference in Modified PCOS Health-related Quality of life questionnaire (mPCOSQ) scoring between participants.
Time frame: 4 months
Change in Polycystic ovarian Syndrome (PCOS) health-related quality of life assessed via the Modified PCOS Health-Related Quality of Life questionnaire (mPCOSQ) at two months and four months from baseline among intervention arm participants compared to controls. Scale Range: The instrument uses a 7-point scale, where lower scores (e.g., 1) represent a high negative impact on quality of life, and higher scores (e.g., 7) represent better quality of life.
3 secondary outcomes
Change in body composition analysis
Time frame: 4 months
Change in visceral adiposity index (VAI)
Time frame: 4 months
Change in fasting glucose, fasting insulin, c-reactive protein (CRP) at four months from baseline among intervention arm participants compared to controls.
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with PCOS (Polycystic Ovary Syndrome), run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Modified PCOS Health-related Quality of life questionnaire (mPCOSQ) scoring between participants. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.