[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07727512":3,"trial-entities:NCT07727512":119,"trial-summary:NCT07727512":123},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":29,"interventions":32,"primary_outcomes":46,"secondary_outcomes":53,"sex":69,"minimum_age":70,"maximum_age":71,"healthy_volunteers":72,"eligibility_criteria":73,"std_ages":95,"locations":97,"central_contacts":107,"overall_officials":113,"references":117,"see_also_links":118},"NCT07727512","2026-0690","PCOS and Brain Health","Functional and Structural Impacts of Polycystic Ovary Syndrome (PCOS) on Brain Health","RECRUITING","2028-08","2026-07","2026-07-28","2026-08","University of Wisconsin, Madison","OTHER",false,"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.","Aim 1: To determine whether individuals with PCOS exhibit reduced CBF at global, lobe and regional brain levels.\n\nAim 2: To assess whether individuals with PCOS have alterations in brain structure including grey and white volume, cortical thickness, or connectivity compared to controls.\n\nAim 3: To evaluate whether individuals with PCOS demonstrate impairments in cognitive performance, including verbal fluency, memory, and processing speed, relative to controls.\n\nAim 4: To characterize systemic immune cell states, circulating inflammatory and metabolic profiles, and epigenomic regulatory landscapes in peripheral blood of individuals with and without PCOS, and to evaluate whether these multiomic signatures are associated with CBF, brain structure, connectivity, and cognitive performance.",[19],"PCOS",[21,22,23,24,25],"brain health","cerebral blood flow","polycystic ovarian syndrome","brain structure","cognition","OBSERVATIONAL",null,[],{"count":30,"type":31},45,"ESTIMATED",[33,42],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":40},"DEVICE","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.",[38,39],"Healthy Controls","Participants with PCOS",[41],"magnetic resonance imaging",{"type":14,"name":43,"description":44,"armGroupLabels":45},"Laboratory Visit","DEXA scan for obtaining body composition, NIH toolbox to assess cognitive test, and optional graded exercise test (GXT).",[38,39],[47,51],{"measure":48,"description":49,"timeFrame":50},"Cerebral Blood Flow (CBF) at rest","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.","data collected during a 2-hour MRI visit (anytime up to 3 months on study)",{"measure":52,"timeFrame":50},"Circulating Sex Hormone Levels",[54,58,61,64,67],{"measure":55,"description":56,"timeFrame":57},"Body composition via DEXA scan","Percent body fat and lean mass to be measured via Dual-Energy X-ray Absorptiometry (DEXA) scan.","data collected during a 2-hour lab visit (anytime up to 3 months on study)",{"measure":59,"description":60,"timeFrame":57},"NIH Toolbox: Dimensional Change Card Sort Test","NIH Toolbox to assess neurocognitive function. The Dimensional Change Card Sort Test measures accuracy: the number of accurate responses, up to a maximum of 40.",{"measure":62,"description":63,"timeFrame":57},"NIH Toolbox: Pattern Comparison Processing Speed Test","NIH Toolbox to assess neurocognitive function. The Pattern Comparison Processing Speed Test measures how many correct responses the participant has within 90 seconds. There is a maximum of 130 items.",{"measure":65,"description":66,"timeFrame":57},"NIH Toolbox: Flanker Inhibitory Control and Attention","NIH Toolbox to assess neurocognitive function. The Flanker test is a measure of executive function and is scored using a T-score where 100 is the average, higher scores indicate better performance.",{"measure":68,"timeFrame":57},"Cardiorespiratory fitness (VO2max) [Optional]","FEMALE","18 Years","45 Years",true,{"inclusion":74,"exclusion":79,"raw_text":94},[75,76,77,78],"Rotterdam criteria demonstrating two out of the three criteria. These are:","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",[80,81,82,83,84,85,86,87,88,89,90,91,92,93],"Current pregnancy","Preexisting diagnosis of type 1 diabetes","Severe obesity (body mass index (BMI) greater than 45kg\u002Fm2)","Preexisting diagnosis of hypertension requiring antihypertensive medication or blood pressure of greater than 160\u002F100 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","Inclusion Criteria (Participants with PCOS):\n\n* Rotterdam criteria demonstrating two out of the three criteria. These are:\n\n  1. Presence of clinical hyperandrogenism or biochemical hyperandrogenism\n  2. A history of irregular menstrual cycles\n  3. Presence of polycystic ovarian morphology on ultrasound\n\nInclusion Criteria (Healthy Controls):\n\n* Regular menstrual cycles (not meeting criteria for irregular cycles above)\n* No diagnosis of PCOS\n* Controls may have isolated hirsutism or polycystic ovaries on ultrasound as long as they do not meet Rotterdam criteria for PCOS\n\nExclusion Criteria:\n\n* Current pregnancy\n* Preexisting diagnosis of type 1 diabetes\n* Severe obesity (body mass index (BMI) greater than 45kg\u002Fm2)\n* Preexisting diagnosis of hypertension requiring antihypertensive medication or blood pressure of greater than 160\u002F100 on two separate occasions during clinical care\n* History of neurologic disease or stroke\n* History of myocardial infarction or deep venous thrombosis\n* Endometriosis confirmed by prior laparoscopy\n* Autoimmune conditions including lupus, multiple sclerosis, and active malignancy\n* Immuno-modulating medications\n* Conditions incompatible with MRI scanning, including but not limited to\n\n  * Certain implanted metal devices or foreign bodies\n  * Severe claustrophobia\n* Post-menopausal\n* Participants will be excluded if they have taken hormonal contraception or fertility medication in the last month",[96],"ADULT",[98],{"facility":99,"status":8,"city":100,"state":101,"zip":102,"country":103,"geoPoint":104},"University of Wisconsin","Madison","Wisconsin","53792","United States",{"lat":105,"lon":106},43.07305,-89.40123,[108],{"name":109,"role":110,"phone":111,"email":112},"Sharon Blohowiak","CONTACT","(608) 262-5977","sblohowiak@wisc.edu",[114],{"name":115,"affiliation":13,"role":116},"Laura Cooney, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":120,"biomarkers":122},[121],"Polycystic Ovary Syndrome",[],{"nct_id":4,"found":72,"summary":124,"prompt_version":134},{"design":125,"status":126,"heading":127,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This is an observational study with a planned enrollment of 45 participants. It is not specified if the study is randomized or blinded.","completed","PCOS and Brain Health Study","This study is looking at how Polycystic Ovary Syndrome (PCOS) affects brain health. Researchers want to understand if PCOS changes how blood flows in the brain (Cerebral Blood Flow or CBF), the brain's structure, and how well people perform on thinking tasks. They will enroll 45 women, both with and without PCOS, between the ages of 18 and 45. You would have two visits, including an MRI scan of your brain and other tests. The study aims to see if women with PCOS have reduced CBF or changes in brain structure and thinking abilities compared to women without PCOS. The study's current status is unclear.","Primary endpoints, like Cerebral Blood Flow and Circulating Sex Hormone Levels, will be measured at data collected during a 2-hour MRI visit (anytime up to 3 months on study).",105,"You would have two visits, including a 1.5-hour MRI scan (55-60 minutes in the MRI) and a laboratory visit for a DEXA scan, cognitive tests, and an optional exercise test. Your participation would last approximately 5 hours over a 1 to 3 month period.","Not stated in the trial record.",[],"v2"]