In Vitro Human Embryo Culture System

Incept Biosystems

Status and phase: Completed; Phase 1

Conditions: Infertility

Treatments: Device: Culture dish; Device: SMART System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00985218

IBS 001 20080202

Details and patient eligibility

About

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.

Full description

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

Enrollment: 40 estimated patients

Sex: Female

Ages: 21 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

experimental arm

Experimental group

Description:

Embryos cultured in SMART System

Treatment:

Device: SMART System

Control

Active Comparator group

Description:

Embryos cultured in microdrops in dishes

Treatment:

Device: Culture dish