Status:
COMPLETED
In Vitro Human Embryo Culture System
Lead Sponsor:
Incept BioSystems, Inc.
Conditions:
Infertility
Eligibility:
FEMALE
21-35 years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
This study is a multi-center, randomized, performance study.
Eligibility Criteria
Inclusion
- Inclusion Criteria - All recruited subjects must meet all of the following inclusion criteria to be enrolled in the study:
- Female 21 to 35 years of age inclusive
- First or second IVF cycle
- Not pregnant
- No physical abnormalities that would adversely affect oocyte retrieval
- Male factor is acceptable
- ICSI is acceptable
- 10 zygotes or more
- Exclusion Criteria- Potential subjects are excluded from the study if any of the following conditions exist:
- The sperm were retrieved using TESE or MESA
- The embryos were created with either donor oocytes or donor sperm.
- Medical condition precluding a safe pregnancy
- Medical condition disqualifying the subject from safely participating in the study in the judgment of the investigator
Exclusion
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00985218
Start Date
November 1 2009
End Date
September 1 2010
Last Update
September 9 2010
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Pacific Fertility Center
San Francisco, California, United States, 94133
2
Florida Fertility Institute
Clearwater, Florida, United States, 33759
3
Southeastern Fertility Center
Mt. Pleasant, South Carolina, United States, 29464
4
Fertility Center of San Antonio
San Antonio, Texas, United States, 78229