Eeva 12-well Dish Study (NDS)

Progyny

Status: Completed

Conditions: Infertility

Treatments: Device: In-vitro fertilization using Eeva

Study type: Observational

Funder types: Industry

Identifiers

NCT01635036

2012-AUX-001

TST-1736-p (Other Identifier)

Details and patient eligibility

About

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

Full 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

Enrollment: 17 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

17 participants in 1 patient group

Women undergoing IVF treatment

Description:

Women undergoing IVF treatment

Treatment:

Device: In-vitro fertilization using Eeva