Eeva™ System Study: Noninvasive Recording and Visualization of Individual Embryos Cultured to Blastocyst Stage (Eeva)

July 20, 2012 updated by: Progyny, Inc.
The purpose of this study is to demonstrate that the Eeva System may be used to identify embryos on Day 2 that are most likely to form blastocysts.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

160

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
    • California
      • Encino, California, United States, 91436
        • HRC Fertility
      • Palo Alto, California, United States, 94304
        • Stanford University
      • San Francisco, California, United States, 94133
        • Pacific Fertility Center
      • San Jose, California, United States, 95124
        • Fertility Physicians of Northern California
      • San Ramon, California, United States, 94583
        • Reproductive Science Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women in the United States who undergo IVF treatment and imaging of their embryos with the Eeva System.

Description

Inclusion Criteria:

  • Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
  • At least 18 years of age.
  • Total antral follicle count of at least 12 as measured by ultrasound prior to stimulation.
  • Basal FSH < 10 IU.
  • At least 8 normally fertilized eggs (2PN.)
  • Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
  • Willing to comply with study protocol and procedures and able to speak English.

Exclusion Criteria:

  • Planned preimplantation genetic diagnosis or preimplantation genetic screening.
  • Gestational carriers.
  • Use of reinseminated eggs.
  • Concurrent participation in another clinical study.
  • Previous enrollment in this clinical study.
  • History of cancer.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women undergoing IVF treatment
Device: Eeva System Study
The Eeva System will image embryos through cleavage and/or blastocyst stage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eeva System correctly predicts on day 2 those embryos that will reach blastocyst stage at day 5.
Time Frame: Embryos cultured through blastocyst stage (Day 5).
Imaging data will be manually analyzed to validate parameters previously determined to be predictive of blastocyst formation.
Embryos cultured through blastocyst stage (Day 5).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy Outcome
Time Frame: Assessed at post embryo transfer day 12-14, post transfer week 5-8, and post transfer week 9-12.
Chemical pregnancy outcome will be assessed using a serum pregnancy test at post transfer day 12-14. Clinical pregnancy outcome will be assessed using vaginal ultrasound at post transfer week 5-8 and week 9-12. Results will be recorded as positive or negative.
Assessed at post embryo transfer day 12-14, post transfer week 5-8, and post transfer week 9-12.

Collaborators and Investigators

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

Sponsor

Progyny, Inc.

Investigators

  • Study Director: Sheua Shen, MD, ELD, Progyny, Inc.

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.

General Publications

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, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

June 7, 2011

First Submitted That Met QC Criteria

June 8, 2011

First Posted (Estimate)

June 9, 2011

Study Record Updates

Last Update Posted (Estimate)

July 24, 2012

Last Update Submitted That Met QC Criteria

July 20, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TST-1057-p

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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