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Trial record 3 of 27 for:    eeva

Eeva System Imaging Study (PROSPECT)

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ClinicalTrials.gov Identifier: NCT02301637
Recruitment Status : Unknown
Verified July 2015 by Progyny, Inc..
Recruitment status was:  Active, not recruiting
First Posted : November 26, 2014
Last Update Posted : July 13, 2015
Sponsor:
Information provided by (Responsible Party):
Progyny, Inc.

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.

Condition or disease Intervention/treatment
Infertility 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
Estimated Enrollment : 500 participants
Time Perspective: Prospective
Official Title: Prospective Observational Study Utilizing the Eeva™ System 2.2.1 for Ongoing Collection of Development and Validation Data
Study Start Date : October 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Intervention Details:
    Device: 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.


Primary Outcome Measures :
  1. Adverse events and device malfunctions will be reported and summarized from the point of Eeva imaging through study exit. [ Time Frame: 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing in vitro fertilization treatment who fulfill all eligibility criteria.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301637


Locations
United States, Illinois
FCI (River North)
Chicago, Illinois, United States, 60610
United States, Indiana
Midwest Fertility Specialists
Carmel, Indiana, United States, 46032
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Texas
Texas Fertility Center
Austin, Texas, United States, 78731
Houston Fertility Institute
Houston, Texas, United States, 77063
United States, Washington
Seattle Reproductive Medicine
Seatlle, Washington, United States, 98109
New Zealand
Fertility Associates
Wellington, New Zealand, 6011
Sponsors and Collaborators
Progyny, Inc.
Investigators
Study Chair: Sheua Shen, MD Vice President, Scientific and Medical Affairs

Responsible Party: Progyny, Inc.
ClinicalTrials.gov Identifier: NCT02301637     History of Changes
Other Study ID Numbers: 2014-AUX-012
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: July 13, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female