Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
475 participants
OBSERVATIONAL
2000-09-30
2008-01-31
Brief Summary
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Detailed Description
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We will investigate this hypothesis through two complimentary aims. In the Background and Significance section, we first present data on a 53-member pedigree segregating an X-linked recessive lethal defect that results in skewed X inactivation in the carrier females via secondary selection against those cells with the defective X chromosome active. We have characterized this deletion to be a 500 kb (approximate) deletion in distal Xq28. Moreover, the carrier females show a statistically significant increase in the frequency of spontaneous abortion as compared to non-deletion carrying relatives. Secondly, in the Preliminary Studies section, we present data from a population based case-control study wherein highly skewed X chromosome inactivation is significantly correlated with idiopathic recurrent spontaneous abortion. This protocol attempts to elucidate the mechanism underlying this association.
The first specific aim is to determine if women with highly skewed X chromosome inactivation are at risk of pregnancy loss. This will be accomplished through a prospective protocol, analyzing X chromosome inactivation patterns in pregnant women and investigating a possible association between X chromosome inactivation and pregnancy outcome. The second aim will study the nature of pregnancy loss in women with skewed X chromosome inactivation. This aim will correlate maternal X inactivation patterns with abortus karyotype.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Given our enrollment strategy, we anticipate enrolling women between the ages of 18 and 45.
Exclusion Criteria
* Children are not eligible to participate in this study. Because the patient populations studied are (aim 1) women with primary infertility undergoing fertility treatment and (aim 2) women who have recently had a spontaneous abortion, the research topic is irrelevant to children.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Crown Family Philanthropies
OTHER
University of Pittsburgh
OTHER
Responsible Party
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Principal Investigators
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W. Allen Hogge, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh and Magee-Womens Hospital
Locations
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Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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0502108
Identifier Type: -
Identifier Source: org_study_id