In Vitro Human Embryo Culture System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00985218
Recruitment Status : Completed
First Posted : September 28, 2009
Last Update Posted : September 9, 2010
Information provided by:
Incept BioSystems, Inc.

September 25, 2009
September 28, 2009
September 9, 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) ]
Same as current
Complete list of historical versions of study NCT00985218 on Archive Site
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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.
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • 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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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
Sexes Eligible for Study: Female
21 Years to 35 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
IBS 001 20080202
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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