Clinical trial NCT02616510: Primary Ovarian Insufficiency, Polycystic Ovary Syndrome & the CardiOvascular Risk Profile
Official title: Primary Ovarian Insufficiency, Polycystic Ovary Syndrome & the CardiOvascular Risk Profile
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Amsterdam UMC, location VUmc
name: Erasmus Medical Center
First posted: 2015-11-30
Enrollment: 125
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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.

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.

Eligibility criteria: Inclusion Criteria:

* age above 45 years

Exclusion Criteria:

* none

Primary outcomes:
measure: carotid intima media thickness
timeFrame: 10 years post diagnosis
Secondary outcomes:
measure: dyslipidemia
timeFrame: 10 years post diagnosis
measure: insulin and glucose levels
timeFrame: 10 years post diagnosis
measure: C-reactive protein
timeFrame: 10 years post diagnosis
measure: homocysteine
timeFrame: 10 years post diagnosis
measure: uric acid
timeFrame: 10 years post diagnosis
measure: androgen levels
timeFrame: 10 years post diagnosis
measure: electrocardiogram (ECG)
timeFrame: 10 years post diagnosis
measure: cardiac ultrasound (hypertrophy)
timeFrame: 10 years post diagnosis
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: UMC Utrecht
name: Bart Fauser, prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.