Brief Summary

The goal of this study is to determine the genetic basis of polycystic ovary syndrome (PCOS). We will first look for genes in the Icelandic population, where large family trees are known and it is easier to search for genes. We will then determine whether these same genes are important in U.S. PCOS patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
20.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 3, 2020

Status Verified

March 1, 2020

Enrollment Period

22.9 years

First QC Date

September 9, 2005

Last Update Submit

March 1, 2020

Conditions

Keywords

Polycystic Ovary Syndrome

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with PCOS age 18 to 40 years, sampled from the population and controls without PCOS.

You may qualify if:

  • A second group of PCOS probands with a documented diagnosis of PCOS will also be recruited. These subjects will meet all of the criteria above except that they will be on hormonal medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

Related Publications (3)

  • Saxena R, Bjonnes AC, Georgopoulos NA, Koika V, Panidis D, Welt CK. Gene variants associated with age at menopause are also associated with polycystic ovary syndrome, gonadotrophins and ovarian volume. Hum Reprod. 2015 Jul;30(7):1697-703. doi: 10.1093/humrep/dev110. Epub 2015 May 20.

  • Saxena R, Georgopoulos NA, Braaten TJ, Bjonnes AC, Koika V, Panidis D, Welt CK. Han Chinese polycystic ovary syndrome risk variants in women of European ancestry: relationship to FSH levels and glucose tolerance. Hum Reprod. 2015 Jun;30(6):1454-9. doi: 10.1093/humrep/dev085. Epub 2015 Apr 22.

  • Pau C, Saxena R, Welt CK. Evaluating reported candidate gene associations with polycystic ovary syndrome. Fertil Steril. 2013 May;99(6):1774-8. doi: 10.1016/j.fertnstert.2012.12.033. Epub 2013 Jan 30.

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Corrine Welt, MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Corrine K Welt, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

January 1, 2003

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 3, 2020

Record last verified: 2020-03

Locations