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Eeva™ Continued Access Study: Assessing the Usability of Eeva in a Clinical Setting (CAS)

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ClinicalTrials.gov Identifier: NCT01617993
Recruitment Status : Completed
First Posted : June 13, 2012
Last Update Posted : January 13, 2014
Sponsor:
Information provided by (Responsible Party):
Progyny, Inc.

Brief Summary:
User questionnaire of Eeva System usability and reports of device malfunctions.

Condition or disease
Infertility

Detailed Description:
This study is designed to evaluate the use of Eeva by IVF laboratory staff during routine procedures. The fertilized eggs will be placed in an Eeva dish and the development of the embryos will be monitored by the Eeva system in a standard incubator. On day 3 of embryo culture, Eeva blastocyst prediction data will be printed from the system to be used to assist the embryologist in selecting the best embryo(s). The performance of the system will be summarized and the user feedback from the embryologists will be collected.

Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Eeva Continued Access Study.
Study Start Date : June 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Group/Cohort
Women undergoing IVF treatment
Women undergoing IVF treatment



Primary Outcome Measures :
  1. User questionnaire of Eeva System usability and reports of device malfunctions. [ Time Frame: Participants will be followed through ongoing pregnancy, at approximately 10-12 weeks gestational age. ]


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Ages Eligible for Study:   18 Years to 40 Years   (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 Eeva.
Criteria

Inclusion Criteria:

  • Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs
  • Subject is ≥ 18 and ≤ 40 years of age.
  • Subject has basal antral follicle count (AFC) ≥ 8 prior to stimulation cycle.
  • Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm.
  • Subject has ≥ 5 normally fertilized eggs (2 PN)
  • Willing to have all 2PN embryos monitored by Eeva
  • Willing to comply with study protocol and procedures and able to speak English.
  • Willing to provide written informed consent.

Exclusion Criteria:

  • Reinseminated eggs.
  • History of cancer.
  • Gestational carriers.
  • Planned preimplantation genetic diagnosis or preimplantation genetic screening.
  • Previously enrolled in this study
  • Concurrent participation in another clinical study.

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): NCT01617993


Locations
United States, California
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.
Investigators
Study Director: Shehua Shen, ELD, MD Progyny, Inc.

Additional Information:
Responsible Party: Progyny, Inc.
ClinicalTrials.gov Identifier: NCT01617993     History of Changes
Other Study ID Numbers: 2012-AUX-002
First Posted: June 13, 2012    Key Record Dates
Last Update Posted: January 13, 2014
Last Verified: January 2014

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
infertility
Genital Diseases, Male
Genital Diseases, Female

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