Eeva 12-well Dish Study

NCT ID: NCT01635036

Last Updated: 2014-01-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2012-08-31

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

Conditions

Infertility

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Women undergoing IVF treatment

Women undergoing IVF treatment

In-vitro fertilization using Eeva

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Progyny, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Boostanfar, MD

Role: PRINCIPAL_INVESTIGATOR

HRC Fertility

Locations

HRC Fertility

Encino, California, United States

Countries

United States

Other Identifiers

TST-1736-p

Identifier Type: OTHER

Identifier Source: secondary_id

2012-AUX-001

Identifier Type: -

Identifier Source: org_study_id