NCT00341731

Brief Summary

Polycystic Ovary Syndrome (PCOS) is manifested as a heterogeneous mixture of clinical and bichemical characteristics that complicate study of its etiology. It is currently unclear to what extent PCOS-associated traits (hyperandrogenism, hyperinsulinemia, insulin resistance, type 2 diabetes, dyslipidemia, hypertension, obesity, and coronary artery disease) are the result of environmental factors or genetic predisposition. We propose to conduct a twin study to investigate the possibility that environmental factors are important in the development of the PCOS phenotype. Twin studies are considered to be the gold standard for determining the extent of heritability of a trait. The proposal described here is only for Step 1 of a larger, multi-step study. The major goal of step 1 is to identify a large cohort of twin pairs, in which at least one member of each pair is likely to have PCOS. Participants for this study will come from the Mid-Atlantic Twin Registry (MATR). Many (3283) potential participants have already been identified based on their answers to a preliminary MATR screening questionnaire. Out of the approximately 7145 twin women of reproductive age who completed these MATR screening questionnaires, 1803 women reported irregular periods, 954 reported ovarian cysts, and 526 reported both irregular periods and ovarian cysts. Many of the women in this last group are likely to have PCOS. They represent 7.4% of the total sample, matching current estimates of PCOS prevalence (4-7%) in reproductive age women. We will also add new twin pairs who meet the criteria (irregular periods and evidence of PCOS or cystic ovaries) as they are recruited into the MATR and take the preliminary surveys. According to MATR statistics, about 33% of twin pairs are monozygotic (MZ, identical). Therefore, approximately 174 of the 526 women likely to have PCOS are members of a MZ pair. Step 1 of the proposed study consists of a telephone survey of the 3282 women with irregular periods and/or ovarian cysts. The survey will be conducted by the MATR. The instrument to be used contains a series of simple and direct questions and will take about 10 minutes to complete. The questions were designed to identify PCOS and their content deals with the frequency of menstrual periods (six or fewer per year being a major diagnostic criterion), a previous diagnosis of PCOS, obesity, excess facial hair and other evidence of hyperandrogenism. The women will also be asked if t...

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

2 active sites

Status
completed

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
Last Updated

December 1, 2009

Status Verified

October 1, 2008

First QC Date

June 19, 2006

Last Update Submit

November 25, 2009

Conditions

Keywords

Cystic OvariesEnvironmental FactorsHeritabilityHyperandrogenismTwin Study

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants will not be excluded based on race, ethnicity or religion.

You may not qualify if:

  • Women under the age of 18 will be excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NIEHS, Research Triangle Park

Research Triangle Park, North Carolina, 27709, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeOvarian CystsHyperandrogenism

Condition Hierarchy (Ancestors)

CystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases46, XX Disorders of Sex DevelopmentDisorders of Sex DevelopmentUrogenital AbnormalitiesAdrenogenital SyndromeMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

December 1, 2000

Last Updated

December 1, 2009

Record last verified: 2008-10

Locations