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CompletedNCT00985218Updated Sep 9, 2010

In Vitro Human Embryo Culture System

A Phase 1 interventional study of SMART System and Culture dish in Infertility, sponsored by Incept BioSystems, Inc.. Completed at 4 sites in United States. Open to female participants aged 21 Years to 35 Years. Per ClinicalTrials.gov, last updated 2010-09-09.

Sponsored by Incept BioSystems, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
21 Years to 35 Years
Sex
Female
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Infertility

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Keywords

  • infertility
  • embryo development
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 40 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

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Lead sponsor

This is the only study on the registry with Incept BioSystems, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 35 Years
Sexes eligible
Female
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:

  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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    experimental arm

    Embryos cultured in SMART System

    Device: SMART System

  • Active comparator
    Control

    Embryos cultured in microdrops in dishes

    Device: Culture dish

Interventions

  • DeviceSMART System

    microfluidic embryo culture system

    Also known as: System for Microfluidically-Assisted Reproductive Technology

  • DeviceCulture dish

    Standard IVF culture dish

    Also known as: dish

06

What researchers measure

Primary outcomes

  1. rate of development of human embryos

    Time frame: Day 3 (t=72 hrs)

07

Study locations

4 sites
  • Pacific Fertility Center
    San Francisco, California 94133, United States
  • Florida Fertility Institute
    Clearwater, Florida 33759, United States
  • Southeastern Fertility Center
    Mount Pleasant, South Carolina 29464, United States
  • Fertility Center of San Antonio
    San Antonio, Texas 78229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00985218
Lead sponsor
Incept BioSystems, Inc.
First posted
Sep 28, 2009
Start date
Nov 2009
Primary completion
Sep 2010
Completion
Sep 2010
Last update
Sep 9, 2010

Study contacts

Thomas B Pool, Ph.D., HCLD
principal investigator · Fertility Center of San Antonio
Joseph Conaghan, Ph.D., HCLD
principal investigator · Pacific Fertility Center
Rodney Wade, BSA, MS, ELD
principal investigator · Southeastern Fertility Center
Kelvin L Fry, B. SC.
principal investigator · Florida Fertility Institute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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