InfertilityPhase 2NCT01003548
Embryo Development in Microfluidics System of Culture
A Phase 2 study testing SMART dynamic system of embryo culture and Static culture in people with Infertility, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Embryo culture is a cornerstone of in vitro fertilization treatments. Usually, embryos are cultured in microdrops of culture media in incubators with controlled temperature, humidity and atmosphere. Read more about this study
- Who is it for?
- Ages 21 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- SMART dynamic system of embryo culture and Static culture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2009to Oct 2011
- Phase
- Phase 2
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 21 and 35 years old
- No more than 1 previous IVF failure
- Absence of physical conditions that can interfere in oocyte quality
- At least 8 zigotes 24 hours after fertilization
Who cannot join
- Use of epididimary or testicular sperm
- Sperm or egg donation
- Untreated systemic diseases
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Departamento de Ginecologia
São Paulo, São Paulo, 04023-900
Jose R Alegretti, BSc, 551130596113, jalegretti@huntington.com.br
Andre M Rocha, PhD, 551130596122, arocha@huntington.com.br
About this study
Official title: Comparison of the in Vitro Development of Human Embryos in Static and and Microfluidics Systems of Culture
Embryo culture is a cornerstone of in vitro fertilization treatments. Usually, embryos are cultured in microdrops of culture media in incubators with controlled temperature, humidity and atmosphere. However, these culture systems are static, while in vivo the initial growth of the embryo takes place in the uterine tube and they are submitted to a dynamic environment. The aim of this study is to compare the embryo development on days 2 and 3 of culture morphological features of embryos under static and dynamic(microfluidics) systems of culture.
Read the detailed description
Embryo culture is a cornerstone of in vitro fertilization treatments. Usually, embryos are cultured in microdrops of culture media in incubators with controlled temperature, humidity and atmosphere. However, these culture systems are static, while in vivo the initial growth of the embryo takes place in the uterine tube and they are submitted to a dynamic environment. The aim of this study is to compare the embryo development on days 2 and 3 of culture morphological features of embryos under static and dynamic(microfluidics) systems of culture.
- Conditions
- Infertility
- Being tested
- SMART dynamic system of embryo culture, Static culture
- Keywords
- Embryo culture, IVF, Microfluidics, infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART dynamic system of embryo cultureDevice
Embryos will be cultured in a dynamic system of microfluidics.
Static cultureDevice
Embryos cultured in 40 microliters microdrops of G-IVF plus series V
| Study group | Role | What they receive |
|---|---|---|
| Static culture | Active comparator | Embryos individually cultured in microdrops of 40 microliters of G-IVFplus series V Receives: Device: Static culture |
| Smart plataform | Experimental | Embryos culture in dynamics microfluidic culture system Receives: Device: SMART dynamic system of embryo culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo morphology on days 2 and 3 of embryo culture according to the criteria described by Lucinda Veeck
Measured: Embryo culture for 3 days before transference to the uterus
Secondary outcomes (1)
Implantation rate and pregnancy rate
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010 (estimated)
- Study completionOct 2011 (estimated)
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 2
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Incept Biosystems
- Investigators
- Eduardo LA Motta, MD, PhD, Study chair, Department of Gynecology - Universidade Federal de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003548
- Sponsor's protocol ID
- 0405/08
- Status last verified
- Oct 2009
- First submitted
- 27 Oct 2009
- Last updated
- 28 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the in Vitro Development of Human Embryos in Static and and Microfluidics Systems of Culture
- ClinicalTrials.gov ID
- NCT01003548
- Acronym / sponsor ID
- 0405/08
- Conditions
- Infertility
- Keywords
- Embryo culture, IVF, Microfluidics, infertility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Incept Biosystems
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 28 Oct 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.
Embryo culture is a cornerstone of in vitro fertilization treatments. Usually, embryos are cultured in microdrops of culture media in incubators with controlled temperature, humidity and atmosphere. However, these culture systems are static, while in vivo the initial growth of the embryo takes place in the uterine tube and they are submitted to a dynamic environment. The aim of this study is to compare the embryo development on days 2 and 3 of culture morphological features of embryos under static and dynamic(microfluidics) systems of culture.
Detailed description
Embryo culture is a cornerstone of in vitro fertilization treatments. Usually, embryos are cultured in microdrops of culture media in incubators with controlled temperature, humidity and atmosphere. However, these culture systems are static, while in vivo the initial growth of the embryo takes place in the uterine tube and they are submitted to a dynamic environment. The aim of this study is to compare the embryo development on days 2 and 3 of culture morphological features of embryos under static and dynamic(microfluidics) systems of culture.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Static culture | Active comparator | Device: Static cultureEmbryos individually cultured in microdrops of 40 microliters of G-IVFplus series V |
| Smart plataform | Experimental | Device: SMART dynamic system of embryo cultureEmbryos culture in dynamics microfluidic culture system |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 21 and 35 years old
- No more than 1 previous IVF failure
- Absence of physical conditions that can interfere in oocyte quality
- At least 8 zigotes 24 hours after fertilization
Key exclusion criteria (3 listed)
- Use of epididimary or testicular sperm
- Sperm or egg donation
- Untreated systemic diseases
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 dynamic system of embryo cultureEmbryos will be cultured in a dynamic system of microfluidics. | Device | Smart plataform |
| Static cultureEmbryos cultured in 40 microliters microdrops of G-IVF plus series V | Device | Static culture |
Primary outcome
Embryo morphology on days 2 and 3 of embryo culture according to the criteria described by Lucinda Veeck
Time frame: Embryo culture for 3 days before transference to the uterus
1 secondary outcome
Implantation rate and pregnancy rate
Time frame: 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2009.
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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.
Eduardo LA Motta, MD, PhD study chair
Department of Gynecology - Universidade Federal de Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SMART dynamic system of embryo culture and Static culture in people with Infertility, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 28 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose R Alegretti, BSc (551130596113, jalegretti@huntington.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Embryo morphology on days 2 and 3 of embryo culture according to the criteria described by Lucinda Veeck (time frame: Embryo culture for 3 days before transference to the uterus). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2009.