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Идёт набор NCT07727512

PCOS and Brain Health

— Наблюдательное PCOS

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: MRI Visit, Laboratory Visit.
Кому может быть актуально
Состояния в реестре: PCOS. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

  • Cerebral Blood Flow (CBF) at rest [Срок оценки: data collected during a 2-hour MRI visit (anytime up to 3 months on study)]
  • Circulating Sex Hormone Levels [Срок оценки: data collected during a 2-hour MRI visit (anytime up to 3 months on study)]
Вторичные конечные точки (5)
  • Body composition via DEXA scan [Срок оценки: data collected during a 2-hour lab visit (anytime up to 3 months on study)]
  • NIH Toolbox: Dimensional Change Card Sort Test [Срок оценки: data collected during a 2-hour lab visit (anytime up to 3 months on study)]
  • NIH Toolbox: Pattern Comparison Processing Speed Test [Срок оценки: data collected during a 2-hour lab visit (anytime up to 3 months on study)]
  • NIH Toolbox: Flanker Inhibitory Control and Attention [Срок оценки: data collected during a 2-hour lab visit (anytime up to 3 months on study)]
  • Cardiorespiratory fitness (VO2max) [Optional] [Срок оценки: data collected during a 2-hour lab visit (anytime up to 3 months on study)]

Критерии участия

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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • University of Wisconsin — Madison

Идентификаторы

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

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗