search
Back to results

In Vitro Human Embryo Culture System

Primary Purpose

Infertility

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SMART System
Culture dish
Sponsored by
Incept BioSystems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring infertility, embryo development

Eligibility Criteria

21 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pacific Fertility Center
  • Florida Fertility Institute
  • Southeastern Fertility Center
  • Fertility Center of San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental arm

Control

Arm Description

Embryos cultured in SMART System

Embryos cultured in microdrops in dishes

Outcomes

Primary Outcome Measures

rate of development of human embryos

Secondary Outcome Measures

Full Information

First Posted
September 25, 2009
Last Updated
September 8, 2010
Sponsor
Incept BioSystems, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00985218
Brief Title
In Vitro Human Embryo Culture System
Official Title
In Vitro Human Embryo Culture System
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Incept BioSystems, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
infertility, embryo development

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental arm
Arm Type
Experimental
Arm Description
Embryos cultured in SMART System
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Embryos cultured in microdrops in dishes
Intervention Type
Device
Intervention Name(s)
SMART System
Other Intervention Name(s)
System for Microfluidically-Assisted Reproductive Technology
Intervention Description
microfluidic embryo culture system
Intervention Type
Device
Intervention Name(s)
Culture dish
Other Intervention Name(s)
dish
Intervention Description
Standard IVF culture dish
Primary Outcome Measure Information:
Title
rate of development of human embryos
Time Frame
Day 3 (t=72 hrs)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas B Pool, Ph.D., HCLD
Organizational Affiliation
Fertility Center of San Antonio
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joseph Conaghan, Ph.D., HCLD
Organizational Affiliation
Pacific Fertility Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rodney Wade, BSA, MS, ELD
Organizational Affiliation
Southeastern Fertility Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kelvin L Fry, B. SC.
Organizational Affiliation
Florida Fertility Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pacific Fertility Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94133
Country
United States
Facility Name
Florida Fertility Institute
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33759
Country
United States
Facility Name
Southeastern Fertility Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Fertility Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

In Vitro Human Embryo Culture System

We'll reach out to this number within 24 hrs