Telomeres and Reproduction in Women

NCT ID: NCT01576991

Last Updated: 2013-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

145 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-06-30

Brief Summary

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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

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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).

Conditions

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InVitro Fertilization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Oocyte collection

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Celso Silva, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Countries

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United States

Other Identifiers

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108093

Identifier Type: -

Identifier Source: org_study_id