Recruiting

Observational StudyPCOS and Brain Health

Sponsor:

University of Wisconsin, Madison

Code:

NCT07727512

Conditions

PCOS

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

MRI Visit

Laboratory Visit

Study Details

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

Study ID

NCT07727512

Start date

Aug 7, 2026

Status verified date

Aug, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants with PCOS

N=30 participants recruited

Healthy Controls

N=15 age and BMI-matched participants recruited

Interventions

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.

Laboratory Visit

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

Primary outcome measure

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) ]

Central Contacts and Locations

Central contacts

Sharon Blohowiak

(608) 262-5977 sblohowiak@wisc.edu

Locations

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

brain health
cerebral blood flow
polycystic ovarian syndrome
brain structure
cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-08-21.