Embryo Development in Microfluidics System of Culture

NCT ID: NCT01003548

Last Updated: 2009-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Static culture

Embryos individually cultured in microdrops of 40 microliters of G-IVFplus series V

Group Type ACTIVE_COMPARATOR

Static culture

Intervention Type DEVICE

Embryos cultured in 40 microliters microdrops of G-IVF plus series V

Smart plataform

Embryos culture in dynamics microfluidic culture system

Group Type EXPERIMENTAL

SMART dynamic system of embryo culture

Intervention Type DEVICE

Embryos will be cultured in a dynamic system of microfluidics.

Interventions

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SMART dynamic system of embryo culture

Embryos will be cultured in a dynamic system of microfluidics.

Intervention Type DEVICE

Static culture

Embryos cultured in 40 microliters microdrops of G-IVF plus series V

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Use of epididimary or testicular sperm
* Sperm or egg donation
* Untreated systemic diseases
Minimum Eligible Age

21 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Incept Biosystems

UNKNOWN

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Universidade Federal de São Paulo

Principal Investigators

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Eduardo LA Motta, MD, PhD

Role: STUDY_CHAIR

Department of Gynecology - Universidade Federal de Sao Paulo

Locations

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Departamento de Ginecologia

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Jose R Alegretti, BSc

Role: CONTACT

551130596113

Andre M Rocha, PhD

Role: CONTACT

551130596122

Facility Contacts

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Jose R Alegretti, BSc

Role: primary

551130596113

Andre M Rocha, PhD

Role: backup

551130596122

Other Identifiers

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0405/08

Identifier Type: -

Identifier Source: org_study_id

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