Eeva System Imaging Study
PROSPECT
Prospective Observational Study Utilizing the Eeva™ System 2.2.1 for Ongoing Collection of Development and Validation Data
1 other identifier
observational
500
2 countries
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2014
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 18, 2014
CompletedFirst Posted
Study publicly available on registry
November 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJuly 13, 2015
July 1, 2015
1.2 years
November 18, 2014
July 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events and device malfunctions will be reported and summarized from the point of Eeva imaging through study exit.
36 months
Interventions
The Eeva System is indicated to provide adjunctive information on events occurring during the first two days of development that may predict further development to the blastocyst stage on Day 5 of development. This adjunctive information aids in the selection of embryo(s) for transfer on Day 3 when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing.
Eligibility Criteria
Patients undergoing in vitro fertilization treatment who fulfill all eligibility criteria.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Progyny, Inc.lead
Study Sites (7)
FCI (River North)
Chicago, Illinois, 60610, United States
Midwest Fertility Specialists
Carmel, Indiana, 46032, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Texas Fertility Center
Austin, Texas, 78731, United States
Houston Fertility Institute
Houston, Texas, 77063, United States
Seattle Reproductive Medicine
Seatlle, Washington, 98109, United States
Fertility Associates
Wellington, 6011, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sheua Shen, MD
Vice President, Scientific and Medical Affairs
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2014
First Posted
November 26, 2014
Study Start
October 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
July 13, 2015
Record last verified: 2015-07