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

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Procedure: cardiovascular screening

• Registration Number: NCT02616510
• Lead Sponsor: UMC Utrecht

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2015-11-20
• Study First Submitted QC: 2015-11-24
• Study First Posted: 2015-11-30
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-10
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 125

Inclusion Criteria

• age above 45 years

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PCOS	cardiovascular screening	Rotterdam criteria (at least 2 out of three criteria present) oligo-anovulation polycystic ovarian morphology hyperandrogenism
POI	cardiovascular screening	amenorrhea of at least 4 months prior to age 40 years, with follicle stimulating hormone (FSH) levels above 40 IU/L

Primary Outcome Measures

Name	Time	Method
carotid intima media thickness	10 years post diagnosis	ultrasound measurement of thickness of carotid wall (mean IMT), presence of atherosclerotic plaques (yes/no, location)

Secondary Outcome Measures

Name	Time	Method
dyslipidemia	10 years post diagnosis	serum measurement of low density lipoprotein cholesterol, triglycerides, total cholesterol, high density lipoprotein cholesterol
electrocardiogram (ECG)	10 years post diagnosis	documentation of heart rythm, potential signs of ischemia (ST segment), length PR, QRS, QT, RR interval
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
cardiac ultrasound (hypertrophy)	10 years post diagnosis	measurement of left ventricular ejection fraction and left ventricular mass,

Trial Locations

Locations (1)

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands