Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 45 Years
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

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 Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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).

Recruiting Locations

University of Wisconsin
Madison, Wisconsin 53792

More Details

Status
Recruiting
Sponsor
University of Wisconsin, Madison

Study Contact

Sharon Blohowiak
(608) 262-5977
sblohowiak@wisc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.