In Vitro Human Embryo Culture System

Phase 1

Completed

• Conditions: Infertility
• Interventions: Device: SMART System; Device: Culture dish

• Registration Number: NCT00985218
• Lead Sponsor: Incept BioSystems, Inc.

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.

Study Timeline

• Study First Submitted: 2009-09-25
• Study First Submitted QC: 2009-09-25
• Study First Posted: 2009-09-28
• Study Start: 2009-11
• Status Verified: 2010-09
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2010-09-08
• Last Update Posted: 2010-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental arm	SMART System	Embryos cultured in SMART System
Control	Culture dish	Embryos cultured in microdrops in dishes

Primary Outcome Measures

Name	Time	Method
rate of development of human embryos	Day 3 (t=72 hrs)

Trial Locations

Locations (4)

Southeastern Fertility Center; 🇺🇸 Mount Pleasant, South Carolina, United States

Fertility Center of San Antonio; 🇺🇸 San Antonio, Texas, United States

Pacific Fertility Center; 🇺🇸 San Francisco, California, United States

Florida Fertility Institute; 🇺🇸 Clearwater, Florida, United States