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

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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.
We found this trial at
1
site
Encino, California 91436
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mi
from
Encino, CA
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