Eeva 12-well Dish Study

Completed

• Conditions: Infertility
• Interventions: Device: In-vitro fertilization using Eeva

• Registration Number: NCT01635036
• Lead Sponsor: Progyny, Inc.

Brief Summary

The purpose of this study is to demonstrate that the Eeva™ System is compatible with the Eeva 12-well Dish.

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 Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-02
• Study First Submitted QC: 2012-07-03
• Study First Posted: 2012-07-06
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-09
• Last Update Posted: 2014-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women undergoing IVF treatment	In-vitro fertilization using Eeva	Women undergoing IVF treatment

Primary Outcome Measures

Name	Time	Method
To validate and develop the Eeva Software.	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).

Secondary Outcome Measures

Name	Time	Method
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.	3 months

Trial Locations

Locations (1)

HRC Fertility; 🇺🇸 Encino, California, United States