- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02616510
Primary Ovarian Insufficiency, Polycystic Ovary Syndrome & the CardiOvascular Risk Profile (POPCORn)
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
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Utrecht, Netherlands
- University Medical Center Utrecht
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
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
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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
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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
|
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homocysteine
Time Frame: 10 years post diagnosis
|
10 years post diagnosis
|
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uric acid
Time Frame: 10 years post diagnosis
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10 years post diagnosis
|
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androgen levels
Time Frame: 10 years post diagnosis
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10 years post diagnosis
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electrocardiogram (ECG)
Time Frame: 10 years post diagnosis
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documentation of heart rythm, potential signs of ischemia (ST segment), length PR, QRS, QT, RR interval
|
10 years post diagnosis
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cardiac ultrasound (hypertrophy)
Time Frame: 10 years post diagnosis
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measurement of left ventricular ejection fraction and left ventricular mass,
|
10 years post diagnosis
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bart Fauser, prof, UMC Utrecht
Publications and helpful links
General Publications
- Gunning MN, Meun C, van Rijn BB, Daan NMP, Roeters van Lennep JE, Appelman Y, Boersma E, Hofstra L, Fauser CGKM, Rueda-Ochoa OL, Ikram MA, Kavousi M, Lambalk CB, Eijkemans MJC, Laven JSE, Fauser BCJM; CREW consortium. The cardiovascular risk profile of middle age women previously diagnosed with premature ovarian insufficiency: A case-control study. PLoS One. 2020 Mar 5;15(3):e0229576. doi: 10.1371/journal.pone.0229576. eCollection 2020.
- Daan NM, Muka T, Koster MP, Roeters van Lennep JE, Lambalk CB, Laven JS, Fauser CG, Meun C, de Rijke YB, Boersma E, Franco OH, Kavousi M, Fauser BC. Cardiovascular Risk in Women With Premature Ovarian Insufficiency Compared to Premenopausal Women at Middle Age. J Clin Endocrinol Metab. 2016 Sep;101(9):3306-15. doi: 10.1210/jc.2016-1141. Epub 2016 Jun 14.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-010
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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