Telomeres and Reproduction in Women

Completed

• Conditions: InVitro Fertilization

• Registration Number: NCT01576991
• Lead Sponsor: University of South Florida

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.

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 Timeline

• Study Start: 2009-06
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-11
• Study First Posted: 2012-04-13
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-09
• Last Update Posted: 2013-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 145

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Frequency of telomeres	1 year	The Primary outcome frequencies in the eggs from older women and associations with aneuploidy.