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

December 10, 2018 updated by: Bart CJM Fauser, UMC Utrecht

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Utrecht, Netherlands
        • University Medical Center Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

women with PCOS according to rotterdam criteria (2 or more of these criteria)

  • oligo/anovulation
  • polycystic ovarian morphology
  • hyperandrogenism

Women with POI amenorrhea of at least 4 months prior to age 40 years with FSH levels above 40 IU/L

Description

Inclusion Criteria:

  • age above 45 years

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Bart Fauser, prof, UMC Utrecht

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 20, 2015

First Submitted That Met QC Criteria

November 24, 2015

First Posted (Estimate)

November 30, 2015

Study Record Updates

Last Update Posted (Actual)

December 11, 2018

Last Update Submitted That Met QC Criteria

December 10, 2018

Last Verified

December 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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