PCOSNCT07727512
PCOS and Brain Health
An observational study of PCOS, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to determine how polycystic ovary syndrome (PCOS) impacts overall brain health, such as cerebral blood flow (CBF), brain structure and connectivity, and cognitive performance. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS
- What is being tested?
- MRI Visit and Laboratory Visit
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2026to Aug 2028
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Reproductive-aged individuals with ovaries, with and without PCOS
Who may be able to join
- Rotterdam criteria demonstrating two out of the three criteria. These are:
- Presence of clinical hyperandrogenism or biochemical hyperandrogenism
- A history of irregular menstrual cycles
- Presence of polycystic ovarian morphology on ultrasound
- Regular menstrual cycles (not meeting criteria for irregular cycles above)
- No diagnosis of PCOS
- Controls may have isolated hirsutism or polycystic ovaries on ultrasound as long as they do not meet Rotterdam criteria for PCOS
Who cannot join
- Current pregnancy
- Preexisting diagnosis of type 1 diabetes
- Severe obesity (body mass index (BMI) greater than 45kg/m2)
- Preexisting diagnosis of hypertension requiring antihypertensive medication or blood pressure of greater than 160/100 on two separate occasions during clinical care
- History of neurologic disease or stroke
- History of myocardial infarction or deep venous thrombosis
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- Endometriosis confirmed by prior laparoscopy
- Autoimmune conditions including lupus, multiple sclerosis, and active malignancy
- Immuno-modulating medications
- Conditions incompatible with MRI scanning, including but not limited to
- Certain implanted metal devices or foreign bodies
- Severe claustrophobia
- Post-menopausal
- Participants will be excluded if they have taken hormonal contraception or fertility medication in the last month
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53792
About this study
Official title: Functional and Structural Impacts of Polycystic Ovary Syndrome (PCOS) on Brain Health
The purpose of this study is to determine how polycystic ovary syndrome (PCOS) impacts overall brain health, such as cerebral blood flow (CBF), brain structure and connectivity, and cognitive performance. 45 reproductive aged (18-45 years) individuals with ovaries, with and without PCOS, will be enrolled to complete brain structure and CBF scans via magnetic resonance imaging (MRI) over 2 testing visits and can expect to be on study for approximately 5 hours over a 1 to 3 month period.
Read the detailed description
Aim 1: To determine whether individuals with PCOS exhibit reduced CBF at global, lobe and regional brain levels.
Aim 2: To assess whether individuals with PCOS have alterations in brain structure including grey and white volume, cortical thickness, or connectivity compared to controls.
Aim 3: To evaluate whether individuals with PCOS demonstrate impairments in cognitive performance, including verbal fluency, memory, and processing speed, relative to controls.
Aim 4: To characterize systemic immune cell states, circulating inflammatory and metabolic profiles, and epigenomic regulatory landscapes in peripheral blood of individuals with and without PCOS, and to evaluate whether these multiomic signatures are associated with CBF, brain structure, connectivity, and cognitive performance.
- Conditions
- PCOS
- Being tested
- MRI Visit, Laboratory Visit
- Keywords
- brain health, cerebral blood flow, polycystic ovarian syndrome, brain structure, cognition
- 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.
MRI VisitDevice
Also called magnetic resonance imaging
MRI visit will take approximately 1.5 hour (55-60 minutes in MRI) and will involve structural scans of the brain, and scans at rest and while performing cognitive tasks.
Laboratory VisitOther
DEXA scan for obtaining body composition, NIH toolbox to assess cognitive test, and optional graded exercise test (GXT).
| Study group | Role | What they receive |
|---|---|---|
| Participants with PCOS | N=30 participants recruited Receives: Device: MRI Visit; Other: Laboratory Visit | |
| Healthy Controls | N=15 age and BMI-matched participants recruited Receives: Device: MRI Visit; Other: Laboratory Visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Blood Flow (CBF) at rest
Arterial Spin Labeling (ASL) color atlases and 4D Flow MRI will be used to measure CBF at rest. CBF will be measured in each of six brain regions: temporal, parietal, frontal, occipital, subcortical, and brainstem.
Measured: data collected during a 2-hour MRI visit (anytime up to 3 months on study)
Circulating Sex Hormone Levels
Measured: data collected during a 2-hour MRI visit (anytime up to 3 months on study)
Secondary outcomes (5)
Body composition via DEXA scan
Percent body fat and lean mass to be measured via Dual-Energy X-ray Absorptiometry (DEXA) scan.
Measured: data collected during a 2-hour lab visit (anytime up to 3 months on study)
NIH Toolbox: Dimensional Change Card Sort Test
NIH Toolbox to assess neurocognitive function. The Dimensional Change Card Sort Test measures accuracy: the number of accurate responses, up to a maximum of 40.
Measured: data collected during a 2-hour lab visit (anytime up to 3 months on study)
NIH Toolbox: Pattern Comparison Processing Speed Test
NIH Toolbox to assess neurocognitive function. The Pattern Comparison Processing Speed Test measures how many correct responses the participant has within 90 seconds. There is a maximum of 130 items.
Measured: data collected during a 2-hour lab visit (anytime up to 3 months on study)
NIH Toolbox: Flanker Inhibitory Control and Attention
NIH Toolbox to assess neurocognitive function. The Flanker test is a measure of executive function and is scored using a T-score where 100 is the average, higher scores indicate better performance.
Measured: data collected during a 2-hour lab visit (anytime up to 3 months on study)
Cardiorespiratory fitness (VO2max) [Optional]
Measured: data collected during a 2-hour lab visit (anytime up to 3 months on study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start7 Aug 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Cooney, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727512
- Sponsor's protocol ID
- 2026-0690
- Other IDs
- Protocol Version 6/29/2026, SMPH / Reproductive Endo (REI), ICTR Pilot Award
- Status last verified
- Aug 2026
- First submitted
- 21 Jul 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Structural Impacts of Polycystic Ovary Syndrome (PCOS) on Brain Health
- ClinicalTrials.gov ID
- NCT07727512
- Acronym / sponsor ID
- 2026-0690
- Conditions
- PCOS
- Keywords
- brain health, cerebral blood flow, polycystic ovarian syndrome, brain structure, cognition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 7 Aug 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 27 Jul 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 purpose of this study is to determine how polycystic ovary syndrome (PCOS) impacts overall brain health, such as cerebral blood flow (CBF), brain structure and connectivity, and cognitive performance. 45 reproductive aged (18-45 years) individuals with ovaries, with and without PCOS, will be enrolled to complete brain structure and CBF scans via magnetic resonance imaging (MRI) over 2 testing visits and can expect to be on study for approximately 5 hours over a 1 to 3 month period.
Detailed description
Aim 1: To determine whether individuals with PCOS exhibit reduced CBF at global, lobe and regional brain levels.
Aim 2: To assess whether individuals with PCOS have alterations in brain structure including grey and white volume, cortical thickness, or connectivity compared to controls.
Aim 3: To evaluate whether individuals with PCOS demonstrate impairments in cognitive performance, including verbal fluency, memory, and processing speed, relative to controls.
Aim 4: To characterize systemic immune cell states, circulating inflammatory and metabolic profiles, and epigenomic regulatory landscapes in peripheral blood of individuals with and without PCOS, and to evaluate whether these multiomic signatures are associated with CBF, brain structure, connectivity, and cognitive performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with PCOS | – | Device: MRI Visit, Other: Laboratory VisitN=30 participants recruited |
| Healthy Controls | – | Device: MRI Visit, Other: Laboratory VisitN=15 age and BMI-matched participants recruited |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Reproductive-aged individuals with ovaries, with and without PCOS
Key inclusion criteria (7 listed)
- Rotterdam criteria demonstrating two out of the three criteria. These are:
- Regular menstrual cycles (not meeting criteria for irregular cycles above)
- No diagnosis of PCOS
- Controls may have isolated hirsutism or polycystic ovaries on ultrasound as long as they do not meet Rotterdam criteria for PCOS
Key exclusion criteria (14 listed)
- Current pregnancy
- Preexisting diagnosis of type 1 diabetes
- Severe obesity (body mass index (BMI) greater than 45kg/m2)
- Preexisting diagnosis of hypertension requiring antihypertensive medication or blood pressure of greater than 160/100 on two separate occasions during clinical care
- History of neurologic disease or stroke
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 |
|---|---|---|
| MRI VisitAlso: magnetic resonance imagingMRI visit will take approximately 1.5 hour (55-60 minutes in MRI) and will involve structural scans of the brain, and scans at rest and while performing cognitive tasks. | Device | Healthy Controls, Participants with PCOS |
| Laboratory VisitDEXA scan for obtaining body composition, NIH toolbox to assess cognitive test, and optional graded exercise test (GXT). | Other | Healthy Controls, Participants with PCOS |
Primary outcome
Cerebral Blood Flow (CBF) at rest
Time frame: data collected during a 2-hour MRI visit (anytime up to 3 months on study)
Arterial Spin Labeling (ASL) color atlases and 4D Flow MRI will be used to measure CBF at rest. CBF will be measured in each of six brain regions: temporal, parietal, frontal, occipital, subcortical, and brainstem.
Circulating Sex Hormone Levels
Time frame: data collected during a 2-hour MRI visit (anytime up to 3 months on study)
5 secondary outcomes
Body composition via DEXA scan
Time frame: data collected during a 2-hour lab visit (anytime up to 3 months on study)
NIH Toolbox: Dimensional Change Card Sort Test
Time frame: data collected during a 2-hour lab visit (anytime up to 3 months on study)
NIH Toolbox: Pattern Comparison Processing Speed Test
Time frame: data collected during a 2-hour lab visit (anytime up to 3 months on study)
NIH Toolbox: Flanker Inhibitory Control and Attention
Time frame: data collected during a 2-hour lab visit (anytime up to 3 months on study)
Cardiorespiratory fitness (VO2max) [Optional]
Time frame: data collected during a 2-hour lab visit (anytime up to 3 months on study)
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 21 Aug 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.
Laura Cooney, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PCOS, run by University of Wisconsin, Madison 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 7 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 21 Aug 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?
Contact Sharon Blohowiak ((608) 262-5977, sblohowiak@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Blood Flow (CBF) at rest (time frame: data collected during a 2-hour MRI visit (anytime up to 3 months on study)). The study lists 2 primary outcomes in all. 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 21 Aug 2026.