In Vitro Human Embryo Culture System

In Vitro Human Embryo Culture System

The purpose of this study is to compare the development of human embryos grown in a conventional culture dish to those grown in a new embryo culture device known as the SMART System.

This study is a multi-center, randomized, performance study.

Inclusion Criteria - All recruited subjects must meet all of the following inclusion criteria to be enrolled in the study:

1. Female 21 to 35 years of age inclusive
2. First or second IVF cycle
3. Not pregnant
4. No physical abnormalities that would adversely affect oocyte retrieval
5. Male factor is acceptable
6. ICSI is acceptable
7. 10 zygotes or more

Exclusion Criteria- Potential subjects are excluded from the study if any of the following conditions exist:

1. The sperm were retrieved using TESE or MESA
2. The embryos were created with either donor oocytes or donor sperm.
3. Medical condition precluding a safe pregnancy
4. Medical condition disqualifying the subject from safely participating in the study in the judgment of the investigator