In Vitro Human Embryo Culture System
This study has been completed.
Sponsor:
Incept BioSystems, Inc.
Information provided by:
Incept BioSystems, Inc.
ClinicalTrials.gov Identifier:
NCT00985218
First received: September 25, 2009
Last updated: September 8, 2010
Last verified: September 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Infertility |
Device: SMART System Device: Culture dish |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | In Vitro Human Embryo Culture System |
Resource links provided by NLM:
Further study details as provided by Incept BioSystems, Inc.:
Primary Outcome Measures:
- rate of development of human embryos [ Time Frame: Day 3 (t=72 hrs) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2009 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: experimental arm
Embryos cultured in SMART System
|
Device: SMART System
microfluidic embryo culture system
Other Name: System for Microfluidically-Assisted Reproductive Technology
|
|
Active Comparator: Control
Embryos cultured in microdrops in dishes
|
Device: Culture dish
Standard IVF culture dish
Other Name: dish
|
Detailed Description:
This study is a multi-center, randomized, performance study.
Eligibility| Ages Eligible for Study: | 21 Years to 35 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985218
Locations
| United States, California | |
| Pacific Fertility Center | |
| San Francisco, California, United States, 94133 | |
| United States, Florida | |
| Florida Fertility Institute | |
| Clearwater, Florida, United States, 33759 | |
| United States, South Carolina | |
| Southeastern Fertility Center | |
| Mount Pleasant, South Carolina, United States, 29464 | |
| United States, Texas | |
| Fertility Center of San Antonio | |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
Incept BioSystems, Inc.
Investigators
| Principal Investigator: | Thomas B Pool, Ph.D., HCLD | Fertility Center of San Antonio |
| Principal Investigator: | Joseph Conaghan, Ph.D., HCLD | Pacific Fertility Center |
| Principal Investigator: | Rodney Wade, BSA, MS, ELD | Southeastern Fertility Center |
| Principal Investigator: | Kelvin L Fry, B. SC. | Florida Fertility Institute |
More Information
No publications provided
| Responsible Party: | Chris Bleck/President and CEO, Incept BioSystems, Inc. |
| ClinicalTrials.gov Identifier: | NCT00985218 History of Changes |
| Other Study ID Numbers: | IBS 001 20080202 |
| Study First Received: | September 25, 2009 |
| Last Updated: | September 8, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Incept BioSystems, Inc.:
|
infertility embryo development |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 21, 2013