X-Chromosome Inactivation Status and Premature Ovarian Failure - Full Text View

Sponsor:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00295087

Purpose

Women who are affected with premature ovarian failure will exhibit skewed X-chromosome inactivation patterns compared to women with normal menstrual function (as defined by being pregnant), indicating a possible X-chromosome defect.

Condition
Premature Ovarian Failure

Study Type:	Observational
Study Design:	Cohort, Cross-Sectional
Official Title:	X-Chromosome Inactivation Status and Premature Ovarian Failure

Resource links provided by NLM:

MedlinePlus related topics: Premature Ovarian Failure

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

DNA that is extarcted from the blood specimen

Estimated Enrollment:	40
Study Start Date:	November 2005
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Detailed Description:

Premature ovarian failure (POF) affects approximately 1% of women. For most women a cause is not found, but structural abnormalities of the X-chromosome commonly lead to POF, suggesting genes on the X-chromosome are necessary for normal ovarian function. It is known that certain gene mutations on the X-chromosome can lead to changes in the normal random pattern of X-chromosome inactivation in females.

We propose to study X-inactivation patterns in a cohort of women with idiopathic POF, and compare their pattern to a mean age-matched cohort of women with normal menstrual function.

We hypothesize that some women with POF will show skewed X-inactivation, suggesting a mutation on the X-chromosome as the etiology of their POF.

Eligibility

Ages Eligible for Study:	20 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Study population will include women diagnosed with POF through clinics. Women diagnosed with POF may also inquire about this study through the Clinical Trials website.

Criteria

Inclusion Criteria:

Women diagnosed with POF.
A chromosomal analysis must have been performed to evaluate X-chromosomal abnormalities, and the results are known to be normal.

Exclusion Criteria:

Patients who have a known etiology for their POF and/or an inability to obtain karyotype results for these patients or unknown X-chromosome abnormalities.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00295087

Locations

United States, Pennsylvania
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Investigators

Principal Investigator:

W. Allen Hogge, MD

University of Pittsburgh and Magee-Womens Hospital

More Information

No publications provided

Responsible Party:	University of Pittsburgh/Magee-Womens Hospital ( W. Allen Hogge, MD )
Study ID Numbers:	0511043
Study First Received:	February 17, 2006
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00295087 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Premature Ovarian Failure
X-Chromosome Inactivation

Additional relevant MeSH terms:

Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

Ovarian Failure, Premature
Ovarian Diseases
Adnexal Diseases

ClinicalTrials.gov processed this record on November 27, 2009