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

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ClinicalTrials.gov Identifier: NCT02616510
Recruitment Status : Completed
First Posted : November 30, 2015
Last Update Posted : December 11, 2018
Sponsor:
Collaborators:
VU University Medical Center
Erasmus Medical Center
Information provided by (Responsible Party):
Bart CJM Fauser, 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.


Condition or disease Intervention/treatment
Cardiovascular Diseases Procedure: cardiovascular screening

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
Actual Enrollment : 125 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Primary Ovarian Insufficiency, Polycystic Ovary Syndrome & the CardiOvascular Risk Profile
Study Start Date : July 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017


Group/Cohort Intervention/treatment
PCOS
Rotterdam criteria (at least 2 out of three criteria present) oligo-anovulation polycystic ovarian morphology hyperandrogenism
Procedure: cardiovascular screening
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
Procedure: cardiovascular screening
cardiovascular screening: serum, urine, ECG, carotid intima media thickness (IMT), cardiac ultrasound




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. dyslipidemia [ Time Frame: 10 years post diagnosis ]
    serum measurement of low density lipoprotein cholesterol, triglycerides, total cholesterol, high density lipoprotein cholesterol

  2. insulin and glucose levels [ Time Frame: 10 years post diagnosis ]
  3. C-reactive protein [ Time Frame: 10 years post diagnosis ]
  4. homocysteine [ Time Frame: 10 years post diagnosis ]
  5. uric acid [ Time Frame: 10 years post diagnosis ]
  6. androgen levels [ Time Frame: 10 years post diagnosis ]
  7. electrocardiogram (ECG) [ Time Frame: 10 years post diagnosis ]
    documentation of heart rythm, potential signs of ischemia (ST segment), length PR, QRS, QT, RR interval

  8. cardiac ultrasound (hypertrophy) [ Time Frame: 10 years post diagnosis ]
    measurement of left ventricular ejection fraction and left ventricular mass,


Biospecimen Retention:   Samples Without DNA
plasma, serum, urine


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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Criteria

Inclusion Criteria:

  • age above 45 years

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616510


Locations
Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
UMC Utrecht
VU University Medical Center
Erasmus Medical Center
Investigators
Principal Investigator: Bart Fauser, prof UMC Utrecht

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bart CJM Fauser, professor, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02616510     History of Changes
Other Study ID Numbers: 13-010
First Posted: November 30, 2015    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018

Additional relevant MeSH terms:
Cardiovascular Diseases
Polycystic Ovary Syndrome
Primary Ovarian Insufficiency
Menopause, Premature
Gonadal Dysgenesis
Turner Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn