NCT03142633

Brief Summary

The aim of this study is to explore the microRNA profile in serum of women with Polycystic Ovary Syndrome and investigate the correlation between the microRNA profile and markers of metabolic syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 9, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2017

Completed
Last Updated

February 27, 2019

Status Verified

March 1, 2017

Enrollment Period

9 months

First QC Date

March 20, 2017

Last Update Submit

February 26, 2019

Conditions

Polycystic Ovary SyndromeInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • MicroRNA profile

    The change in relative expression of MicroRNA in women with PCOS will be assessed, using TaqMan microRNA arrays, comparing serum samples from baseline from an existing biobank with serum samples from a follow up visit.

    MicroRNA analysis will be performed on serum from baseline visit (biobank material) and on serum obtained from a follow-up visit 5 years after baseline. The participants will be examined for 2 hours at follow up.

Secondary Outcomes (6)

  • Insulin Resistance and Type 2 Diabetes

    The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.

  • Blood Pressure

    The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.

  • Abdominal obesity

    The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.

  • Overweight

    The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.

  • Dyslipidemia

    The participants will be examined for 2 hours, at a follow-up visit 5 years after the baseline visit.

  • +1 more secondary outcomes

Study Arms (1)

Women with Polycystic Ovary Syndrome

Participants of the PICOLO study Inclusion criteria: Women aged 18-40 years when included in the PICOLO-cohort, PCOS based on the Rotterdam 2003 consensus criteria Exclusion criteria: Contraceptive pills within 6 weeks from examination, endocrinological disease (i.e. diabetes, thyroid dysfunction), endometriosis and premature ovarian insufficiency, breastfeeding women and pregnancy.

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Local Participants from the PICOLO study, performed at Holbæk Hospital between 2010 and 2013

You may qualify if:

  • Women between 18 and 40 years when included in the PICOLO study
  • PCOS based on the Rotterdam 2003 consensus criteria

You may not qualify if:

  • Contraceptive pills within 8 weeks from examination,
  • endocrinological disease (i.e. type 1 diabetes thyroid dysfunction),
  • Severe endometriosis (stage III and IV)
  • Premature ovarian insufficiency,
  • Breastfeeding women and
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Clinic,Department of Gynecology and Obstetrics

Holbæk, 4300, Denmark

Location

Related Publications (2)

  • Udesen PB, Sorensen AE, Svendsen R, Frisk NLS, Hess AL, Aziz M, Wissing MLM, Englund ALM, Dalgaard LT. Circulating miRNAs in Women with Polycystic Ovary Syndrome: A Longitudinal Cohort Study. Cells. 2023 Mar 23;12(7):983. doi: 10.3390/cells12070983.

    PMID: 37048055DERIVED

  • Udesen PB, Sorensen AE, Joglekar MV, Hardikar AA, Wissing MLM, Englund AM, Dalgaard LT. Levels of circulating insulin cell-free DNA in women with polycystic ovary syndrome - a longitudinal cohort study. Reprod Biol Endocrinol. 2019 Apr 5;17(1):34. doi: 10.1186/s12958-019-0478-7.

    PMID: 30953560DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum Buffy Coat

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin Resistance

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Anne Lis M Englund, DsMC

    Fertility Clinic, Dept. of Gynecology and Obstetrics, Holbæk Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2017

First Posted

May 5, 2017

Study Start

September 9, 2016

Primary Completion

May 23, 2017

Study Completion

May 23, 2017

Last Updated

February 27, 2019

Record last verified: 2017-03

Locations

DK(1)