Eeva System Imaging Study
This trial is active, not recruiting.
|Start date||October 2014|
|End date||December 2015|
|Trial size||500 participants|
|Trial identifier||NCT02301637, 2014-AUX-012|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Chicago, IL||FCI (River North)||no longer recruiting|
|Carmel, IN||Midwest Fertility Specialists||no longer recruiting|
|Iowa City, IA||University of Iowa||no longer recruiting|
|Austin, TX||Texas Fertility Center||no longer recruiting|
|Houston, TX||Houston Fertility Institute||no longer recruiting|
|Seatlle, WA||Seattle Reproductive Medicine||no longer recruiting|
|Wellington, New Zealand||Fertility Associates||no longer recruiting|
Adverse events and device malfunctions will be reported and summarized from the point of Eeva imaging through study exit.
time frame: 36 months
Female participants at least 18 years old.
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
|Official title||Prospective Observational Study Utilizing the Eeva™ System 2.2.1 for Ongoing Collection of Development and Validation Data|
|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)|
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