In Vitro Human Embryo Culture System

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.

Completed

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

21 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Pacific Fertility Center, San Francisco, California, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMART System

Device

microfluidic embryo culture system

Other names: System for Microfluidically-Assisted Reproductive Technology

Culture dish

Device

Standard IVF culture dish

Other names: dish

Primary outcomes

rate of development of human embryos

Time frame: Day 3 (t=72 hrs)

Sponsors and collaborators

Lead sponsor

Incept BioSystems, Inc.

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Sep 28, 2009
Registry last updated: Sep 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed