Eeva System Imaging Study (PROSPECT)

Prospective Observational Study Utilizing the Eeva™ System 2.2.1 for Ongoing Collection of Development and Validation Data

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.

Study Overview

• Status: Unknown
• Conditions: Infertility
• Intervention / Treatment: Device: Eeva™ Test

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• New Zealand
  • Wellington, New Zealand, 6011
    • Fertility Associates
• United States
  • Illinois
    • Chicago, Illinois, United States, 60610
      • FCI (River North)
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Midwest Fertility Specialists
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Fertility Center
    • Houston, Texas, United States, 77063
      • Houston Fertility Institute
  • Washington
    • Seatlle, Washington, United States, 98109
      • Seattle Reproductive Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing in vitro fertilization treatment who fulfill all eligibility criteria.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Progyny, Inc.
• Investigators: Study Chair: Sheua Shen, MD, Vice President, Scientific and Medical Affairs

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: November 18, 2014
• First Submitted That Met QC Criteria: November 22, 2014
• First Posted (Estimate): November 26, 2014

Study Record Updates

• Last Update Posted (Estimate): July 13, 2015
• Last Update Submitted That Met QC Criteria: July 9, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: 2014-AUX-012