Eeva 12-well Dish Study
Status: | Completed |
---|---|
Conditions: | Women's Studies, Infertility |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | Any |
Updated: | 9/23/2012 |
Start Date: | June 2012 |
End Date: | November 2012 |
Contact: | Wendy Shubin, PA |
Email: | wendys@havingbabies.com |
Phone: | 818-788-7288 |
The purpose of this study is to demonstrate that the Eeva™ System is compatible with the
Eeva 12-well Dish.
This study is designed to demonstrate that the Eeva System Software successfully tracks the
embryo images and identifies the timing of key developmental events using the Eeva 12-well
Dish.
This is a prospective, observational, blinded, single arm, nonrandomized, single center
clinical study. Images of developing embryos and Eeva predictions will be blinded to
embryologists and physicians
Inclusion Criteria:
- Women undergoing fresh in vitro fertilization treatment using their own eggs or donor
eggs.
- Subject is at least 18 years of age.
- Subject has basal antral follicle count (BAFC) ≥ 12 prior to stimulation cycle.
- Subjects has basal FSH < 11 IU
- Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed
sperm.
- Subject has at least 8 normally fertilized eggs (2PN)
- 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.
- Any other reason the Investigator believes the subject should not participate in the
clinical study.
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