NCT01576991

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2009

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

August 13, 2013

Status Verified

August 1, 2013

Enrollment Period

4 years

First QC Date

April 10, 2012

Last Update Submit

August 9, 2013

Conditions

InVitro Fertilization

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Frequency of telomeres

    1 year

Study Arms (1)

Oocyte collection

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

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

InVItro Fertilization patients undergoing therapy

You may qualify if:

  • Ages 18 to 48
  • Undergoing InVitro Fertilization
  • Willing to donate spare eggs, granulosa cells and blood
  • Willing to give written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Follicle cells, and or polar body of eggs

Study Officials

  • Celso Silva, MD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2012

First Posted

April 13, 2012

Study Start

June 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

August 13, 2013

Record last verified: 2013-08