InfertilityPhase 1NCT00985218

In Vitro Human Embryo Culture System

A Phase 1 study testing SMART System and Culture dish in people with Infertility, run by Incept BioSystems, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 more about this study

Who is it for?: Ages 21 to 35 years, women only
Conditions the study is for: Infertility
What is being tested?: SMART System and Culture dish
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 4 sitesUnited States
Study dates: Nov 2009to Sep 2010
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 35 years
Women only
No healthy volunteers
Adult

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Florida Fertility Institute
Clearwater, Florida, 33759
Southeastern Fertility Center
Mt. Pleasant, South Carolina, 29464
Fertility Center of San Antonio
San Antonio, Texas, 78229
Pacific Fertility Center
San Francisco, California, 94133

Other trials in United States

About this study

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.

Conditions: Infertility
Being tested: SMART System, Culture dish
Keywords: infertility, embryo development
Medical subject headings: Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SMART SystemDevice
Also called System for Microfluidically-Assisted Reproductive Technology
microfluidic embryo culture system
Culture dishDevice
Also called dish
Standard IVF culture dish

Study groups in NCT00985218
Study group	Role	What they receive
experimental arm	Experimental	Embryos cultured in SMART System Receives: Device: SMART System
Control	Active comparator	Embryos cultured in microdrops in dishes Receives: Device: Culture dish

What is being measured

The primary outcome is the main question the study is designed to answer.

rate of development of human embryos
Measured: Day 3 (t=72 hrs)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2009Sep 2010

First posted28 Sep 2009 (estimated)
Study startNov 2009
Primary completionSep 2010
Study completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for InfertilityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00985218
Sponsor's protocol ID: IBS 001 20080202
Status last verified: Sep 2010
First submitted: 25 Sep 2009
Last updated: 9 Sep 2010
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
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Automation of the In Vitro Fertilization Laboratory
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Not yet recruiting
Implementing IVM for Fertility Treatment in Clinical Practice
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All Infertility trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: In Vitro Human Embryo Culture System
ClinicalTrials.gov ID: NCT00985218
Acronym / sponsor ID: IBS 001 20080202
Conditions: Infertility
Keywords: infertility, embryo development
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (estimated)
Lead sponsor: Incept BioSystems, Inc.Industry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 28 Sep 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
experimental arm	Experimental	Device: SMART SystemEmbryos cultured in SMART System
Control	Active comparator	Device: Culture dishEmbryos cultured in microdrops in dishes

Who may qualify

Ages: 21 to 35 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SMART SystemAlso: System for Microfluidically-Assisted Reproductive Technologymicrofluidic embryo culture system	Device	experimental arm
Culture dishAlso: dishStandard IVF culture dish	Device	Control

Primary outcome

rate of development of human embryos
Time frame: Day 3 (t=72 hrs)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2010.

Related trials for Infertility

RecruitingPhase 3
A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
Infertility
Active, not recruitingObservational study
Fresh Versus Vitrified-Warmed Donor Oocytes: Embryological and Clinical Outcomes
Infertility, Donor Oocyte Assisted Reproduction
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
Not yet recruiting
Implementing IVM for Fertility Treatment in Clinical Practice
Infertility

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SMART System and Culture dish in people with Infertility, run by Incept BioSystems, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rate of development of human embryos (time frame: Day 3 (t=72 hrs)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00985218.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2010.