Eeva 12-well Dish Study (NDS)

January 9, 2014 updated by: Progyny, Inc.
The purpose of this study is to demonstrate that the Eeva™ System is compatible with the Eeva 12-well Dish.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is designed to demonstrate that the Eeva System Software successfully tracks the embryo images and identifies the timing of key developmental events using the Eeva 12-well Dish.

This is a prospective, observational, blinded, single arm, nonrandomized, single center clinical study. Images of developing embryos and Eeva predictions will be blinded to embryologists and physicians

Study Type

Observational

Enrollment (Actual)

17

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

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

Probability Sample

Study Population

Women in the United States who undergo IVF treatment

Description

Inclusion Criteria:

  • Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
  • Subject is at least 18 years of age.
  • Subject has basal antral follicle count (BAFC) ≥ 12 prior to stimulation cycle.
  • Subjects has basal FSH < 11 IU
  • Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
  • Subject has at least 8 normally fertilized eggs (2PN)
  • Willing to have all 2PN embryos monitored by Eeva
  • Willing to comply with study protocol and procedures and able to speak English.
  • Willing to provide written informed consent.

Exclusion Criteria:

  • Reinseminated eggs.
  • History of cancer.
  • Gestational carriers.
  • Planned preimplantation genetic diagnosis or preimplantation genetic screening.
  • Previously enrolled in this study
  • Concurrent participation in another clinical study.
  • Any other reason the Investigator believes the subject should not participate in the clinical study.

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: In-vitro fertilization using Eeva
Eeva will image embryos through cleavage stage (Day 3). Embryologists will use Eeva results along with traditional morphological grading to assist in selecting embryo(s) for transfer or freezing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To validate and develop the Eeva Software.
Time Frame: 3 months
The clinical image data (embryos images) will be used to develop the Eeva System Software. The Eeva software validation will consist in comparing the specificity of the Eeva System Software Blastocyst Prediction from the Eeva 12-well Dish to the specificity of the Eeva System Software from the Eeva 25-well Dish (the specificity of the Eeva System Software from the Eeva 25-well Dish was previously determined during the Eeva System Study TST-1788-r).
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Specificity and sensitivity and 95% confidence intervals of the Eeva System Software and the Embryologist Panel (also referred to as Panel) measurements will be computed.
Time Frame: 3 months
3 months

Other Outcome Measures

Outcome Measure
Time Frame
The postive/negative (in-window/out-window) agreement of the Eeva Software and Panel measurements will be compared.
Time Frame: 3 months
3 months
The Mean Absolute Difference (MAD) will be calculated between each observer (Eeva Software, Panelist 1, Panelist 2, and Panelist 3)
Time Frame: 3 months
3 months
Bland Altman plots for the differences between each observer.
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Progyny, Inc.

Investigators

  • Principal Investigator: Robert Boostanfar, MD, HRC Fertility

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)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2012

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 13, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-AUX-001
  • TST-1736-p (OTHER: Auxogyn, Inc.)

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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