NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

PCOS and Brain Health
PCOS and Brain Health

NCT07727512

RecruitingN/A

Sponsor: University of Wisconsin, Madison

Conditions: PCOS

Interventions: MRI Visit, Laboratory Visit

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 45 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (1)
  • Madison, Wisconsin, United States