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X-Chromosome Inactivation Status and Premature Ovarian Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00295087
First Posted: February 22, 2006
Last Update Posted: December 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Pittsburgh
  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: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: X-Chromosome Inactivation Status and Premature Ovarian Failure

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Skewed X-Inactivation appears increased in women with Premature Ovarian Failure [ Time Frame: 4 years ]

Biospecimen Retention:   Samples With DNA
DNA that is extracted from the blood specimen

Enrollment: 13
Study Start Date: November 2005
Study Completion Date: October 2009
Primary Completion Date: October 2009 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00295087     History of Changes
Other Study ID Numbers: 0511043
First Submitted: February 17, 2006
First Posted: February 22, 2006
Last Update Posted: December 8, 2014
Last Verified: December 2014

Keywords provided by University of Pittsburgh:
Premature Ovarian Failure
X-Chromosome Inactivation

Additional relevant MeSH terms:
Premature Birth
Primary Ovarian Insufficiency
Menopause, Premature
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases