Molecular Associations With Reproductive Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
CROWN Foundation
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00298116
First received: February 27, 2006
Last updated: July 12, 2011
Last verified: July 2011

February 27, 2006
July 12, 2011
September 2000
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Complete list of historical versions of study NCT00298116 on ClinicalTrials.gov Archive Site
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Molecular Associations With Reproductive Failure
Molecular Associations With Reproductive Failure

The overall hypothesis to be tested is: women with the molecular phenotype of highly skewed X chromosome inactivation are at increased risk of spontaneous abortion.

The overall hypothesis to be tested is: women with the molecular phenotype of highly skewed X chromosome inactivation are at increased risk of spontaneous abortion.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

Patients are recruited through Genetics during a counseling session.

  • Spontaneous Abortions
  • Infertility
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
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Inclusion Criteria:

  • Patients are prospectively ascertained women with either a new pregnancy (specific aim 1), or a spontaneous abortion (specific aim 2).
  • Given our enrollment strategy, we anticipate enrolling women between the ages of 18 and 45.

Exclusion Criteria:

  • The study is limited only to females.
  • 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.
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00298116
0502108
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W. Allen Hogge, MD, Magee-Womens Hospital-University of Pittsburgh
University of Pittsburgh
CROWN Foundation
Principal Investigator: W. Allen Hogge, MD University of Pittsburgh and Magee-Womens Hospital
University of Pittsburgh
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP