In Vitro Human Embryo Culture System

September 8, 2010 updated by: Incept BioSystems, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a multi-center, randomized, performance study.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94133
        • Pacific Fertility Center
    • Florida
      • Clearwater, Florida, United States, 33759
        • Florida Fertility Institute
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Southeastern Fertility Center
    • Texas
      • San Antonio, Texas, United States, 78229
        • Fertility Center of San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental arm
Embryos cultured in SMART System
Device: SMART System
microfluidic embryo culture system
Other Names:
  • System for Microfluidically-Assisted Reproductive Technology
Active Comparator: Control
Embryos cultured in microdrops in dishes
Device: Culture dish
Standard IVF culture dish
Other Names:
  • dish

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of development of human embryos
Time Frame: Day 3 (t=72 hrs)
Day 3 (t=72 hrs)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

September 25, 2009

First Submitted That Met QC Criteria

September 25, 2009

First Posted (Estimate)

September 28, 2009

Study Record Updates

Last Update Posted (Estimate)

September 9, 2010

Last Update Submitted That Met QC Criteria

September 8, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBS 001 20080202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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