Telomeres and Reproduction in Women

InVitro Fertilization Clinical Trial

Official title:

Telomeres and Reproduction in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01576991
• Other study ID #: 108093
• Status: Completed
• Phase: N/A
• First received: April 10, 2012
• Last updated: August 9, 2013
• Start date: June 2009
• Est. completion date: June 2013

Study information

• Verified date: August 2013
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• InVitro Fertilization

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Frequency of telomeres	The Primary outcome frequencies in the eggs from older women and associations with aneuploidy.	1 year	No