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

NCT ID: NCT02616510

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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PCOS

Rotterdam criteria (at least 2 out of three criteria present) oligo-anovulation polycystic ovarian morphology hyperandrogenism

cardiovascular screening

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

cardiovascular screening: serum, urine, ECG, carotid intima media thickness (IMT), cardiac ultrasound

Interventions

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cardiovascular screening

cardiovascular screening: serum, urine, ECG, carotid intima media thickness (IMT), cardiac ultrasound

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age above 45 years

Exclusion Criteria

* none
Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Amsterdam UMC, location VUmc

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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Bart CJM Fauser

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bart Fauser, prof

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

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University Medical Center Utrecht

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 32134933 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27300572 (View on PubMed)

Other Identifiers

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13-010

Identifier Type: -

Identifier Source: org_study_id