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

UMC Utrecht

Status: Completed

Conditions: Cardiovascular Diseases

Treatments: Procedure: cardiovascular screening

Study type: Observational

Funder types: Other

Identifiers

NCT02616510

13-010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age above 45 years

Exclusion criteria

• none

Trial design

125 participants in 2 patient groups

PCOS

Description:

Rotterdam criteria (at least 2 out of three criteria present) oligo-anovulation polycystic ovarian morphology hyperandrogenism

Treatment:

Procedure: cardiovascular screening

POI

Description:

amenorrhea of at least 4 months prior to age 40 years, with follicle stimulating hormone (FSH) levels above 40 IU/L

Treatment:

Procedure: cardiovascular screening