Prospective Observational Study Utilizing the Eeva™ System 2.2.1 for Ongoing Collection of Development and Validation Data
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infertility
- Sponsor
- Progyny, Inc.
- Enrollment
- 500
- Locations
- 7
- Primary Endpoint
- Adverse events and device malfunctions will be reported and summarized from the point of Eeva imaging through study exit.
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed 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)
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Adverse events and device malfunctions will be reported and summarized from the point of Eeva imaging through study exit.
Time Frame: 36 months