Telomeres and Reproduction in Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01576991
First received: April 10, 2012
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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
InVitro Fertilization

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Telomeres and Reproduction in Women

Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Telomere length [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Frequency of telomeres [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The Primary outcome frequencies in the eggs from older women and associations with aneuploidy.


Biospecimen Retention:   Samples With DNA

Blood, Follicle cells, and or polar body of eggs


Enrollment: 145
Study Start Date: June 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Oocyte collection
This is an observational study; there are no cohorts or groups

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).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

InVItro Fertilization patients undergoing therapy

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576991

Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Celso Silva, MD University of South Florida
  More Information

Additional Information:
No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01576991     History of Changes
Other Study ID Numbers: 108093
Study First Received: April 10, 2012
Last Updated: August 9, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 15, 2014