Correlating Time-Lapse Parameters Detected by the Eeva™ System With Comprehensive Chromosome Screening Results (CCS)

January 12, 2015 updated by: Progyny, Inc.

Correlating Time-Lapse Parameters Detected by the Eeva™ System With Comprehensive Chromosome Screening Results,Implantation and Live Birth

The purpose of this research study protocol is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) and correlate Eeva System parameters with comprehensive chromosome screening (CCS) results, implantation and live birth.

Study Overview

Status

Completed

Conditions

Detailed Description

The present study was designed to determine if there is a correlation between the Eeva System parameters and CCS results. Embryos will be selected for transfer based on CCS results and morphology. The Clinical site will have no access to the Eeva analysis at the time of the transfer.

Study Type

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Reproductive Medicine Associates of New Jersey
    • New York
      • New York, New York, United States, 10022
        • Reproductive Medicine Associates of New York

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 43 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women undergoing fresh IVF treatment and undergoing CCS, as recommended based on medical need by the clinical site reproductive endocrinologist.

Description

Inclusion Criteria:

  • Subject is ≤43 years of age.
  • Women undergoing fresh IVF treatment using her own eggs or donor eggs and undergoing CCS, as recommended based on medical need by the clinical site reproductive endocrinologist.
  • Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm.
  • Willing to have all 2PN embryos monitored by Eeva
  • Not previously enrolled in this study.
  • No concurrent participation in another clinical study.
  • Willing to comply with study protocol and procedures and able to speak English.
  • Willing to provide written informed consent.

Exclusion Criteria:

  • BMI ≥ 40
  • Prior IVF cycle with < 4 x 2PN

  • Diminished ovarian reserve as demonstrated by any one of the following:

    • BAFC < 6 at time of cycle start
    • Maximum prior FSH > 15
    • AMH < 0.5

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Women undergoing IVF treatment and CCS
•Women undergoing fresh IVF treatment and undergoing CCS, as recommended based on medical need by the clinical site reproductive endocrinologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eeva time-lapse parameters and CCS
Time Frame: 5-6 days
Analyse the correlation of time-lapse parameters collected by the Eeva System and comprehensive chromosome screening (CCS) results.
5-6 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation of time-lapse parameters collected by the Eeva System and implantation rate.
Time Frame: 6 weeks
6 weeks
Correlation of time-lapse parameters collected by the Eeva System and clinical pregnancy rate
Time Frame: 6 weeks
6 weeks
Correlation of time-lapse parameters collected by the Eeva System and ongoing pregnancy rate
Time Frame: 7 - 8 weeks
7 - 8 weeks
Correlation of time-lapse parameters collected by the Eeva System and delivery rate
Time Frame: live birth
live birth
Correlation of time-lapse parameters collected by the Eeva System and spontaneous miscarriage rate
Time Frame: live birth
live birth
Correlation of time-lapse parameters collected by the Eeva System and multiple pregnancy rate
Time Frame: live birth
live birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Progyny, Inc.

Investigators

  • Principal Investigator: Richard T Scott, Jr., MD, Reproductive Medicine Associates of New Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

July 2, 2012

First Submitted That Met QC Criteria

July 3, 2012

First Posted (Estimate)

July 6, 2012

Study Record Updates

Last Update Posted (Estimate)

January 14, 2015

Last Update Submitted That Met QC Criteria

January 12, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-AUX-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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