In Vitro Human Embryo Culture System - Full Text View

Sponsor:	Incept BioSystems, Inc.
Information provided by:	Incept BioSystems, Inc.
ClinicalTrials.gov Identifier:	NCT00985218

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 I

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:

MedlinePlus related topics: Infertility

U.S. FDA Resources

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 February 09, 2012