PCOS and Brain Health

NCT07727512 | Recruiting

• 4 other identifiers: 2026-0690Protocol Version 6/29/2026SMPH / Reproductive Endo (REI)ICTR Pilot Award
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

PCOS

Keywords

brain health; cerebral blood flow; polycystic ovarian syndrome; brain structure; cognition

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Body composition via DEXA scan

  data collected during a 2-hour lab visit (anytime up to 3 months on study)

• NIH Toolbox: Dimensional Change Card Sort Test

  data collected during a 2-hour lab visit (anytime up to 3 months on study)

• NIH Toolbox: Pattern Comparison Processing Speed Test

  data collected during a 2-hour lab visit (anytime up to 3 months on study)

• NIH Toolbox: Flanker Inhibitory Control and Attention

  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)

Study Arms (2)

Participants with PCOS

N=30 participants recruited

Device: MRI Visit; Other: Laboratory Visit

Healthy Controls

N=15 age and BMI-matched participants recruited

Device: MRI Visit; Other: Laboratory Visit

Interventions

MRI Visit DEVICE

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.

Also known as: magnetic resonance imaging

Healthy Controls; Participants with PCOS

Laboratory Visit OTHER

DEXA scan for obtaining body composition, NIH toolbox to assess cognitive test, and optional graded exercise test (GXT).

Healthy Controls; Participants with PCOS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Reproductive-aged individuals with ovaries, with and without PCOS

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood draw prior to MRI visit will be used to collect 40ml of blood

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Laura Cooney, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Blohowiak

CONTACT

(608) 262-5977; sblohowiak@wisc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)