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Recruiting NCT07727512

PCOS and Brain Health

— Observational PCOS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI Visit, Laboratory Visit.
Who it may be relevant to
Registry conditions: PCOS. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Functional and Structural Impacts of Polycystic Ovary Syndrome (PCOS) on Brain Health

Overview

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.

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)]
  • Circulating Sex Hormone Levels [Time frame: data collected during a 2-hour MRI visit (anytime up to 3 months on study)]
Secondary outcome measures (5)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Wisconsin — Madison

Identifiers

NCT: NCT07727512 · 2026-0690 · Protocol Version 6/29/2026 · SMPH / Reproductive Endo (REI) · ICTR Pilot Award

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗