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: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: 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
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands
    • University Medical Center Utrecht

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Collaborators: Erasmus Medical Center; Amsterdam UMC, location VUmc
• 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: 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

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Cardiovascular Diseases; Polycystic Ovary Syndrome; Primary Ovarian Insufficiency; Menopause, Premature
• Other Study ID Numbers: 13-010