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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Auxogyn, Inc.
ClinicalTrials.gov Identifier:
NCT01617993
First received: June 8, 2012
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

User questionnaire of Eeva System usability and reports of device malfunctions.


Condition
Infertility

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Eeva Continued Access Study.

Resource links provided by NLM:


Further study details as provided by Auxogyn, Inc.:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: June 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Women undergoing IVF treatment
Women undergoing IVF treatment

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Auxogyn, Inc.
Investigators
Study Director: Shehua Shen, ELD, MD Auxogyn, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Auxogyn, Inc.
ClinicalTrials.gov Identifier: NCT01617993     History of Changes
Other Study ID Numbers: 2012-AUX-002
Study First Received: June 8, 2012
Last Updated: January 9, 2014
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
infertility
Genital Diseases, Male
Genital Diseases, Female

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

ClinicalTrials.gov processed this record on April 17, 2014