Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

In Vitro Human Embryo Culture System

This study has been completed.
Sponsor:
Information provided by:
Incept BioSystems, Inc.
ClinicalTrials.gov Identifier:
NCT00985218
First received: September 25, 2009
Last updated: September 8, 2010
Last verified: September 2010

September 25, 2009
September 8, 2010
November 2009
September 2010   (final data collection date for primary outcome measure)
rate of development of human embryos [ Time Frame: Day 3 (t=72 hrs) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00985218 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Infertility
  • Device: SMART System
    microfluidic embryo culture system
    Other Name: System for Microfluidically-Assisted Reproductive Technology
  • Device: Culture dish
    Standard IVF culture dish
    Other Name: dish
  • Experimental: experimental arm
    Embryos cultured in SMART System
    Intervention: Device: SMART System
  • Active Comparator: Control
    Embryos cultured in microdrops in dishes
    Intervention: Device: Culture dish
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Female
21 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00985218
IBS 001 20080202
No
Chris Bleck/President and CEO, Incept BioSystems, Inc.
Incept BioSystems, Inc.
Not Provided
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
Incept BioSystems, Inc.
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP