Eeva™ System Study: Noninvasive Recording and Visualization of Individual Embryos Cultured to Blastocyst Stage
This study has been completed.
Information provided by (Responsible Party):
First received: June 7, 2011
Last updated: July 20, 2012
Last verified: July 2012
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.
|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:
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.
|Study Start Date:||June 2011|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
|Women undergoing IVF treatment||
Device: Eeva System Study
The Eeva System will image embryos through cleavage and/or blastocyst stage.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369446
|United States, California|
|Encino, California, United States, 91436|
|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
|Study Director:||Sheua Shen, MD, ELD||Auxogyn, Inc.|