Eeva System Imaging Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Infertility

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Eeva™ Test

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes