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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Auxogyn, Inc.
ClinicalTrials.gov Identifier:
NCT01617993
First received: June 8, 2012
Last updated: November 12, 2012
Last verified: November 2012
History of Changes

June 8, 2012
November 12, 2012
June 2012
November 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01617993 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Eeva™ Continued Access Study: Assessing the Usability of Eeva in a Clinical Setting
Eeva Continued Access Study.

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

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Women in the United States who undergo IVF treatment and imaging of their embryos with Eeva.
Infertility
Device: Eeva is an Assisted Reproductive Microscope with accessories
Eeva will image embryos through cleavage stage (Day 3). Embryologists will use Eeva prediction along with traditional morphological grading to assist in selecting the best embryo(s).
Women undergoing IVF treatment
Intervention: Device: Eeva is an Assisted Reproductive Microscope with accessories
Wong CC, Loewke KE, Bossert NL, Behr B, De Jonge CJ, Baer TM, Reijo Pera RA. Non-invasive imaging of human embryos before embryonic genome activation predicts development to the blastocyst stage. Nat Biotechnol. 2010 Oct;28(10):1115-21. Epub 2010 Oct 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
December 2012
November 2012   (final data collection date for primary outcome measure)

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.
Female
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01617993
2012-AUX-002
No
Auxogyn, Inc.
Auxogyn, Inc.
Not Provided
Study Director: Shehua Shen, ELD, MD Auxogyn, Inc.
Auxogyn, Inc.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP