Eeva System Imaging Study



Status:Active, not recruiting
Conditions:Women's Studies, Infertility
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2014
End Date:December 2015

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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.

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)

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
We found this trial at
7
sites
101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Austin, Texas 78731
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Carmel, Indiana 46032
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Chicago, Illinois 60610
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Houston, Texas 77063
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Seatlle, Washington 98109
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Wellington,
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