Clinical trial · Observational
PCOS and Brain Health
Functional and Structural Impacts of Polycystic Ovary Syndrome (PCOS) on Brain Health
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PCOS | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Visit | Other | — | UNRESOLVED |
| MRI Visit | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Participants with PCOS
- description
- N=30 participants recruited
- interventionNames
- Device: MRI Visit
- Other: Laboratory Visit
- label
- Healthy Controls
- description
- N=15 age and BMI-matched participants recruited
- interventionNames
- Device: MRI Visit
- Other: Laboratory Visit
Primary outcomes (2)
- measure
- Cerebral Blood Flow (CBF) at rest
- timeFrame
- data collected during a 2-hour MRI visit (anytime up to 3 months on study)
- description
- Arterial Spin Labeling (ASL) color atlases and 4D Flow MRI will be used to measure CBF at rest. CBF will be measured in each of six brain regions: temporal, parietal, frontal, occipital, subcortical, and brainstem.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available