Primary Ovarian Insufficiency, Polycystic Ovary Syndrome & the CardiOvascular Risk Profile

Study Overview
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Brief Summary
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The polycystic ovary syndrome (PCOS) is the most common endocrinopathy amongst women of reproductive age. PCOS is associated with various cardiovascular risk factors such as obesity, glucose intolerance, dyslipidemia hypertension and the metabolic syndrome. Whether these increased cardiovascular risk factors result in the development of actual cardiovascular disease in later life remains to be established. Women with premature ovarian insufficiency (POI), experience menopause prior to the age of 40 years. Women with POI may exhibit dyslipidemia. A young age at menopause has been previously associated with increased cardiovascular morbidity and mortality.

Detailed Description
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Cardiovascular risk profile will be assessed in women with PCOS and POI > 45 years of age, consisting of: fasting serum and urine analyses blood pressure, length, weight, waist circumference, hip circumference ECG carotid intima media thickness cardiac ultrasound spare serum, plasma and urine will be stored in -80 degrees celsius biobank.

Official Title
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Primary Ovarian Insufficiency, Polycystic Ovary Syndrome & the CardiOvascular Risk Profile

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Procedure: cardiovascular screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age above 45 years Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCOS<br>Rotterdam criteria (at least 2 out of three criteria present) oligo-anovulation polycystic ovarian morphology hyperandrogenism | Procedure: cardiovascular screening<br>* cardiovascular screening: serum, urine, ECG, carotid intima media thickness (IMT), cardiac ultrasound<br>|
| POI<br>amenorrhea of at least 4 months prior to age 40 years, with follicle stimulating hormone (FSH) levels above 40 IU/L | Procedure: cardiovascular screening<br>* cardiovascular screening: serum, urine, ECG, carotid intima media thickness (IMT), cardiac ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| carotid intima media thickness | ultrasound measurement of thickness of carotid wall (mean IMT), presence of atherosclerotic plaques (yes/no, location) | 10 years post diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dyslipidemia | serum measurement of low density lipoprotein cholesterol, triglycerides, total cholesterol, high density lipoprotein cholesterol | 10 years post diagnosis | 
| insulin and glucose levels |  | 10 years post diagnosis | 
| C-reactive protein |  | 10 years post diagnosis | 
| homocysteine |  | 10 years post diagnosis | 
| uric acid |  | 10 years post diagnosis | 
| androgen levels |  | 10 years post diagnosis | 
| electrocardiogram (ECG) | documentation of heart rythm, potential signs of ischemia (ST segment), length PR, QRS, QT, RR interval | 10 years post diagnosis | 
| cardiac ultrasound (hypertrophy) | measurement of left ventricular ejection fraction and left ventricular mass, | 10 years post diagnosis |