Clincosm LogoSign in Get a demo

Telomeres and Reproduction in Women

Sponsor
University of South Florida (Other)
Overall Status
Completed
CT.gov ID
NCT01576991
Collaborator
(none)
145
Enrollment
48
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of the study is to describe the relationship between leukocyte, granulose cell and polar body telomere length, telomere injury foci (TIFs), polarized light microscopy of oocyte spindles and their frequency in the eggs from older women and associations with aneuploidy.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The chances of conception decrease and miscarriage increase with a women's age, and the locus of reproductive aging is the egg (1). Egg dysfunction affects most women beginning by their late '30's and for many women age related egg dysfunction represents a major cause of infertility. The cause of age related egg dysfunction is poorly understood, but telomere dysfunction may play an important role. Our group has demonstrated that genetic or pharmacologic shortening of telomeres in the eggs of mice, which normally do not exhibit age related egg dysfunction, mimics reproductive aging in women, with cell cycle arrest, apoptosis, spindle dysmorphologies and chromosomal abnormalities (1,2). Moreover, a pilot study the investigators conducted five years ago suggested that telomere length of spare human eggs may predict the outcome of womens' InVitro Fertilization (IVF) cycles (3). Subsequently, other investigators have demonstrated that telomere length of circulating leukocytes predicts miscarriages (4).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    145 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Telomeres and Reproduction in Women
    Study Start Date :
    Jun 1, 2009
    Actual Primary Completion Date :
    Jun 1, 2013
    Actual Study Completion Date :
    Jun 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Oocyte collection

    This is an observational study; there are no cohorts or groups

    Outcome Measures

    Primary Outcome Measures

    1. Telomere length [1 year]

      Describe the relationship between leukocyte, granulose cell and polar body telomere length, telomere injury foci (TIFs), polarized light microscopy of oocyte spindles

    Secondary Outcome Measures

    1. Frequency of telomeres [1 year]

      The Primary outcome frequencies in the eggs from older women and associations with aneuploidy.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Ages 18 to 48

    • Undergoing InVitro Fertilization

    • Willing to donate spare eggs, granulosa cells and blood

    • Willing to give written informed consent

    Exclusion Criteria:

    • Not undergoing InVitro Fertilization

    • Not willing to donate spare eggs, granulosa cells or blood

    • Not willing to give written informed consent

    • Previously donated spare eggs, granulosa cells or blood for this research project

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of South Florida

    Investigators

    • Principal Investigator: Celso Silva, MD, University of South Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of South Florida
    ClinicalTrials.gov Identifier:
    NCT01576991
    Other Study ID Numbers:
    • 108093
    First Posted:
    Apr 13, 2012
    Last Update Posted:
    Aug 13, 2013
    Last Verified:
    Aug 1, 2013

    Study Results

    No Results Posted as of Aug 13, 2013