NCT07727512 · University of Wisconsin, Madison
PCOS and Brain Health
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
MRI Visit
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.
OTHER
Laboratory Visit
DEXA scan for obtaining body composition, NIH toolbox to assess cognitive test, and optional graded exercise test (GXT).
Primary outcome measures
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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- (Participants with PCOS):
- 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 Inclusion Criteria (Healthy Controls):
- 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
Exclusion criteria
- 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
- 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
Where
- Madison, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 21, 2026 · Source of record for eligibility and locations