PCOS and Brain Health

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.

Study Overview

• Status: Recruiting
• Conditions: PCOS
• Intervention / Treatment: Device: MRI Visit; Other: Laboratory Visit

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 Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

• Study Contact: Name: Sharon Blohowiak; Phone Number: (608) 262-5977; Email: sblohowiak@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Recruiting
      • University Of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Reproductive-aged individuals with ovaries, with and without PCOS

Description

Inclusion Criteria (Participants with PCOS):

• Rotterdam criteria demonstrating two out of the three criteria. These are:

  1. Presence of clinical hyperandrogenism or biochemical hyperandrogenism
  2. A history of irregular menstrual cycles
  3. 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with PCOS; N=30 participants recruited	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 Names: magnetic resonance imaging; Other: Laboratory Visit; DEXA scan for obtaining body composition, NIH toolbox to assess cognitive test, and optional graded exercise test (GXT).
Healthy Controls; N=15 age and BMI-matched participants recruited	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 Names: magnetic resonance imaging; Other: Laboratory Visit; DEXA scan for obtaining body composition, NIH toolbox to assess cognitive test, and optional graded exercise test (GXT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	data collected during a 2-hour MRI visit (anytime up to 3 months on study)
Circulating Sex Hormone Levels		data collected during a 2-hour MRI visit (anytime up to 3 months on study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition via DEXA scan	Percent body fat and lean mass to be measured via Dual-Energy X-ray Absorptiometry (DEXA) scan.	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.	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.	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.	data collected during a 2-hour lab visit (anytime up to 3 months on study)
Cardiorespiratory fitness (VO2max) [Optional]		data collected during a 2-hour lab visit (anytime up to 3 months on study)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Laura Cooney, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): August 21, 2026
• Last Update Submitted That Met QC Criteria: August 19, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: cognition; cerebral blood flow; brain health; polycystic ovarian syndrome; brain structure
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Polycystic Ovary Syndrome; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Magnetic Resonance Imaging
• Other Study ID Numbers: 2026-0690; Protocol Version 6/29/2026 (Other Identifier: UW Madison); SMPH / Reproductive Endo (REI) (Other Identifier: UW Madison); ICTR Pilot Award (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No