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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Auxogyn, Inc.
ClinicalTrials.gov Identifier:
NCT01369446
First received: June 7, 2011
Last updated: July 20, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Infertility
 Device: Eeva System Study

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Eeva™ System Study: Noninvasive Recording and Visualization of Individual Embryos Cultured to Blastocyst Stage

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Auxogyn, Inc.:

Primary Outcome Measures:
  • 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). ] [ Designated as safety issue: No ]
    Imaging data will be manually analyzed to validate parameters previously determined to be predictive of blastocyst formation.


Secondary Outcome Measures:
  • Pregnancy Outcome [ Time Frame: Assessed at post embryo transfer day 12-14, post transfer week 5-8, and post transfer week 9-12. ] [ Designated as safety issue: No ]
    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.


Enrollment: 160
Study Start Date: June 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Women undergoing IVF treatment Device: Eeva System Study
The Eeva System will image embryos through cleavage and/or blastocyst stage.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369446

Locations
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
Auxogyn, Inc.
Investigators
Study Director: Sheua Shen, MD, ELD Auxogyn, Inc.
  More Information

Publications:

Responsible Party: Auxogyn, Inc.
ClinicalTrials.gov Identifier: NCT01369446     History of Changes
Other Study ID Numbers: TST-1057-p
Study First Received: June 7, 2011
Last Updated: July 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Auxogyn, 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:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on June 18, 2013