Embryo Development in Microfluidics System of Culture

October 27, 2009 updated by: Federal University of São Paulo

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04023-900
        • Recruiting
        • Departamento de Ginecologia
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eduardo LA Motta, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Static culture
Embryos individually cultured in microdrops of 40 microliters of G-IVFplus series V
Device: Static culture
Embryos cultured in 40 microliters microdrops of G-IVF plus series V
Experimental: Smart plataform
Embryos culture in dynamics microfluidic culture system
Device: SMART dynamic system of embryo culture
Embryos will be cultured in a dynamic system of microfluidics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Embryo culture for 3 days before transference to the uterus

Secondary Outcome Measures

Outcome Measure
Time Frame
Implantation rate and pregnancy rate
Time Frame: 24 month
24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Incept Biosystems

Investigators

  • Study Chair: Eduardo LA Motta, MD, PhD, Department of Gynecology - Universidade Federal de Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

October 1, 2010

Study Completion (Anticipated)

October 1, 2011

Study Registration Dates

First Submitted

October 27, 2009

First Submitted That Met QC Criteria

October 27, 2009

First Posted (Estimate)

October 28, 2009

Study Record Updates

Last Update Posted (Estimate)

October 28, 2009

Last Update Submitted That Met QC Criteria

October 27, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0405/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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