Eeva™ System Study: Noninvasive Recording and Visualization of Individual Embryos Cultured to Blastocyst Stage (Eeva)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01369446
Recruitment Status : Completed
First Posted : June 9, 2011
Last Update Posted : July 24, 2012
Information provided by (Responsible Party):
Progyny, Inc.

Brief Summary:
The purpose of this study is to demonstrate that the Eeva System may be used to identify embryos on Day 2 that are most likely to form blastocysts.

Condition or disease Intervention/treatment
Infertility Device: Eeva System Study

Study Type : Observational
Actual Enrollment : 160 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Eeva™ System Study: Noninvasive Recording and Visualization of Individual Embryos Cultured to Blastocyst Stage
Study Start Date : June 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Group/Cohort Intervention/treatment
Women undergoing IVF treatment Device: Eeva System Study
The Eeva System will image embryos through cleavage and/or blastocyst stage.

Primary Outcome Measures :
  1. Eeva System correctly predicts on day 2 those embryos that will reach blastocyst stage at day 5. [ Time Frame: Embryos cultured through blastocyst stage (Day 5). ]
    Imaging data will be manually analyzed to validate parameters previously determined to be predictive of blastocyst formation.

Secondary Outcome Measures :
  1. Pregnancy Outcome [ Time Frame: Assessed at post embryo transfer day 12-14, post transfer week 5-8, and post transfer week 9-12. ]
    Chemical pregnancy outcome will be assessed using a serum pregnancy test at post transfer day 12-14. Clinical pregnancy outcome will be assessed using vaginal ultrasound at post transfer week 5-8 and week 9-12. Results will be recorded as positive or negative.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women in the United States who undergo IVF treatment and imaging of their embryos with the Eeva System.

Inclusion Criteria:

  • Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
  • At least 18 years of age.
  • Total antral follicle count of at least 12 as measured by ultrasound prior to stimulation.
  • Basal FSH < 10 IU.
  • At least 8 normally fertilized eggs (2PN.)
  • Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
  • Willing to comply with study protocol and procedures and able to speak English.

Exclusion Criteria:

  • Planned preimplantation genetic diagnosis or preimplantation genetic screening.
  • Gestational carriers.
  • Use of reinseminated eggs.
  • Concurrent participation in another clinical study.
  • Previous enrollment in this clinical study.
  • History of cancer.

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 identifier (NCT number): NCT01369446

United States, California
HRC Fertility
Encino, California, United States, 91436
Stanford University
Palo Alto, California, United States, 94304
Pacific Fertility Center
San Francisco, California, United States, 94133
Fertility Physicians of Northern California
San Jose, California, United States, 95124
Reproductive Science Center
San Ramon, California, United States, 94583
Sponsors and Collaborators
Progyny, Inc.
Study Director: Sheua Shen, MD, ELD Progyny, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Progyny, Inc. Identifier: NCT01369446     History of Changes
Other Study ID Numbers: TST-1057-p
First Posted: June 9, 2011    Key Record Dates
Last Update Posted: July 24, 2012
Last Verified: July 2012

Keywords provided by Progyny, Inc.:
In vitro fertilization
Assisted reproduction
Noninvasive imaging of embryos
Time lapse imaging of embryos
Traditional morphological grading of embryos
Prediction of blastocysts

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