Eeva System Imaging Study

• Conditions: Infertility

• Registration Number: NCT02301637
• Lead Sponsor: Progyny, Inc.

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)

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-11-18
• Study First Submitted QC: 2014-11-22
• Study First Posted: 2014-11-26
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-09
• Last Update Posted: 2015-07-13
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events and device malfunctions will be reported and summarized from the point of Eeva imaging through study exit.	36 months

Trial Locations

Locations (7)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Fertility Associates; 🇳🇿 Wellington, New Zealand

FCI (River North); 🇺🇸 Chicago, Illinois, United States

Houston Fertility Institute; 🇺🇸 Houston, Texas, United States

Midwest Fertility Specialists; 🇺🇸 Carmel, Indiana, United States

Seattle Reproductive Medicine; 🇺🇸 Seatlle, Washington, United States

Texas Fertility Center; 🇺🇸 Austin, Texas, United States