NCT02616510

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 30, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

4.4 years

First QC Date

November 20, 2015

Last Update Submit

December 10, 2018

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • dyslipidemia

    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

  • +3 more secondary outcomes

Study Arms (2)

PCOS

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

Procedure: cardiovascular screening

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

Interventions

cardiovascular screeningPROCEDURE

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

PCOSPOI

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • age above 45 years

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht

Utrecht, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 32134933DERIVED

  • 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.

    PMID: 27300572DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma, serum, urine

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Bart Fauser, prof

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 20, 2015

First Posted

November 30, 2015

Study Start

July 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 11, 2018

Record last verified: 2018-12

Locations

NL(1)