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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.

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.

Condition or disease Intervention/treatment Phase
Infertility Device: SMART System Device: Culture dish Phase 1

Detailed Description:
This study is a multi-center, randomized, performance study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: In Vitro Human Embryo Culture System
Study Start Date : November 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. rate of development of human embryos [ Time Frame: Day 3 (t=72 hrs) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00985218

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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.
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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
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Responsible Party: Chris Bleck/President and CEO, Incept BioSystems, Inc. Identifier: NCT00985218    
Other Study ID Numbers: IBS 001 20080202
First Posted: September 28, 2009    Key Record Dates
Last Update Posted: September 9, 2010
Last Verified: September 2010
Keywords provided by Incept BioSystems, Inc.:
embryo development
Additional relevant MeSH terms:
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Genital Diseases, Male
Genital Diseases, Female