Eeva™ System Study: Noninvasive Recording and Visualization of Individual Embryos Cultured to Blastocyst Stage

Progyny

Status: Completed

Conditions: Infertility

Treatments: Device: Eeva System Study

Study type: Observational

Funder types: Industry

Identifiers

NCT01369446

TST-1057-p

Details and patient eligibility

About

The purpose of this study is to demonstrate that the Eeva System may be used to identify embryos on Day 2 that are most likely to form blastocysts.

Enrollment: 160 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.
• At least 18 years of age.
• Total antral follicle count of at least 12 as measured by ultrasound prior to stimulation.
• Basal FSH < 10 IU.
• At least 8 normally fertilized eggs (2PN.)
• Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
• Willing to comply with study protocol and procedures and able to speak English.

Exclusion criteria

• Planned preimplantation genetic diagnosis or preimplantation genetic screening.
• Gestational carriers.
• Use of reinseminated eggs.
• Concurrent participation in another clinical study.
• Previous enrollment in this clinical study.
• History of cancer.

Trial design

160 participants in 1 patient group

Women undergoing IVF treatment

Treatment:

Device: Eeva System Study