In Vitro Human Embryo Culture System

NCT ID: NCT00985218

Last Updated: 2010-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-09-30

Brief Summary

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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

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

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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experimental arm

Embryos cultured in SMART System

Group Type EXPERIMENTAL

SMART System

Intervention Type DEVICE

microfluidic embryo culture system

Control

Embryos cultured in microdrops in dishes

Group Type ACTIVE_COMPARATOR

Culture dish

Intervention Type DEVICE

Standard IVF culture dish

Interventions

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SMART System

microfluidic embryo culture system

Intervention Type DEVICE

Culture dish

Standard IVF culture dish

Intervention Type DEVICE

Other Intervention Names

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System for Microfluidically-Assisted Reproductive Technology dish

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Incept BioSystems, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Incept BioSystems, Inc.

Principal Investigators

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Thomas B Pool, Ph.D., HCLD

Role: PRINCIPAL_INVESTIGATOR

Fertility Center of San Antonio

Joseph Conaghan, Ph.D., HCLD

Role: PRINCIPAL_INVESTIGATOR

Pacific Fertility Center

Rodney Wade, BSA, MS, ELD

Role: PRINCIPAL_INVESTIGATOR

Southeastern Fertility Center

Kelvin L Fry, B. SC.

Role: PRINCIPAL_INVESTIGATOR

Florida Fertility Institute

Locations

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Pacific Fertility Center

San Francisco, California, United States

Site Status

Florida Fertility Institute

Clearwater, Florida, United States

Site Status

Southeastern Fertility Center

Mt. Pleasant, South Carolina, United States

Site Status

Fertility Center of San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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IBS 001 20080202

Identifier Type: -

Identifier Source: org_study_id