Telomeres and Reproduction in Women

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.

Study Overview

• Status: Completed
• Conditions: InVitro Fertilization

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 Type: Observational
• Enrollment (Actual): 145

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

InVItro Fertilization patients undergoing therapy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Oocyte collection; This is an observational study; there are no cohorts or groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Telomere length	Describe the relationship between leukocyte, granulose cell and polar body telomere length, telomere injury foci (TIFs), polarized light microscopy of oocyte spindles	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of telomeres	The Primary outcome frequencies in the eggs from older women and associations with aneuploidy.	1 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 10, 2012
• First Submitted That Met QC Criteria: April 11, 2012
• First Posted (Estimate): April 13, 2012

Study Record Updates

• Last Update Posted (Estimate): August 13, 2013
• Last Update Submitted That Met QC Criteria: August 9, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 108093

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No