Infertility Clinical Trial
Official title:
In Vitro Human Embryo Culture System
Verified date | September 2010 |
Source | Incept BioSystems, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years to 35 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Florida Fertility Institute | Clearwater | Florida |
United States | Southeastern Fertility Center | Mount Pleasant | South Carolina |
United States | Fertility Center of San Antonio | San Antonio | Texas |
United States | Pacific Fertility Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
Incept BioSystems, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | rate of development of human embryos | Day 3 (t=72 hrs) | No |
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