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Eeva 12-well Dish Study (NDS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Auxogyn, Inc.
ClinicalTrials.gov Identifier:
NCT01635036
First received: July 2, 2012
Last updated: January 9, 2014
Last verified: January 2014

July 2, 2012
January 9, 2014
June 2012
August 2012   (final data collection date for primary outcome measure)
To validate and develop the Eeva Software. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
Not Provided
  • The postive/negative (in-window/out-window) agreement of the Eeva Software and Panel measurements will be compared. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • The Mean Absolute Difference (MAD) will be calculated between each observer (Eeva Software, Panelist 1, Panelist 2, and Panelist 3) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Bland Altman plots for the differences between each observer. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Women in the United States who undergo IVF treatment

Infertility
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01635036
2012-AUX-001, TST-1736-p
No
Auxogyn, Inc.
Auxogyn, Inc.
Not Provided
Principal Investigator: Robert Boostanfar, MD HRC Fertility
Auxogyn, Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP