PCOS and Brain Health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study uses MRI and cognitive testing to compare brain blood flow, structure, and connectivity between individuals with PCOS and healthy controls. Participants will undergo two testing visits over 1 to 3 months, including MRI scans and lab work, totaling about 5 hours. The study also looks at immune and metabolic profiles to see how they relate to brain measures and cognition. Findings may reveal brain and systemic differences associated with PCOS and guide future research on brain health in this population.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Wisconsin
  Madison, Wisconsin, United States Recruiting

Study contacts

• Principal investigator: Laura Cooney, MD — University of Wisconsin, Madison
• Study coordinator: Sharon Blohowiak
• Email: sblohowiak@wisc.edu
• Phone: (608) 262-5977

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• Comparing adipokine levels in women with and without PCOS

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• Using liraglutide to improve fertility in obese women with PCOS

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.