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
  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:

  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
  Contacts and Locations
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, see Learn About Clinical Studies.

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 September 22, 2014