Eeva 12-well Dish Study (NDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01635036
Recruitment Status : Completed
First Posted : July 6, 2012
Last Update Posted : January 13, 2014
Information provided by (Responsible Party):
Progyny, Inc.

July 2, 2012
July 6, 2012
January 13, 2014
June 2012
August 2012   (Final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01635036 on Archive Site
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 ]
Not Provided
  • The postive/negative (in-window/out-window) agreement of the Eeva Software and Panel measurements will be compared. [ Time Frame: 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 ]
  • Bland Altman plots for the differences between each observer. [ Time Frame: 3 months ]
Not Provided
Eeva 12-well Dish Study
Eeva 12-well Dish Study
The purpose of this study is to demonstrate that the Eeva™ System is compatible with the Eeva 12-well Dish.

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

Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Probability Sample
Women in the United States who undergo 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.
Women undergoing IVF treatment
Women undergoing IVF treatment
Intervention: Device: In-vitro fertilization using Eeva
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2012
August 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
TST-1736-p ( Other Identifier: Auxogyn, Inc. )
Not Provided
Not Provided
Progyny, Inc.
Progyny, Inc.
Not Provided
Principal Investigator: Robert Boostanfar, MD HRC Fertility
Progyny, Inc.
January 2014