Eeva System Imaging Study (PROSPECT)

Progyny

Status: Unknown

Conditions: Infertility

Treatments: Device: Eeva™ Test

Study type: Observational

Funder types: Industry

Identifiers

NCT02301637

2014-AUX-012

Details and patient eligibility

About

The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.

Full description

The purpose of this clinical trial is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) for ongoing development and validation of the Eeva System.

Primary Objectives Include:

To collect imaging data on embryos followed to blastocyst stage (Day 5-6)

Secondary Objectives Include:

To collect enrollment data: demographics, IVF and pregnancy history To collect Day 3, Day 5 and Day 6 embryo morphology data To collect pregnancy test and outcome data To collect pre-implantation genetic screening (PGS) data (if applicable) To collect Frozen Embryo Transfer (FET) data (if applicable)

Enrollment: 500 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• At least 18 years of age
• Women undergoing in vitro fertilization treatment using their own eggs
• Fresh or Frozen Blastocyst (Day 5-6) transfer
• At least 5 diploid (2PN) embryos at fertilization check
• Willing to have all 2PN embryos imaged by Eeva
• Willing to comply with study protocol and procedures
• Willing to provide written informed consent

Exclusion criteria

• Freeze-all due to ovarian hyperstimulation syndrome (OHSS)
• Use of donor egg / gestational carrier
• Fertilization using surgically removed sperm
• History of cancer
• Assisted Hatching (AH) on Day 3