PCOS and Brain Health
Recruiting · NCT07727512 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Wisconsin, Madison
View the official record on ClinicalTrials.gov →Interventions studied
Laboratory VisitMRI Visit
What this trial is about
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.
Who can take part
Age range
18 Years to 45 Years
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed across 1 US state.
- University of Wisconsin - Madison, Wisconsin, United States