Text Size

Embryo Development in Microfluidics System of Culture

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Incept Biosystems
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01003548
First received: October 27, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Infertility
 Device: SMART dynamic system of embryo culture
Device: Static culture
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Comparison of the in Vitro Development of Human Embryos in Static and and Microfluidics Systems of Culture

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Implantation rate and pregnancy rate [ Time Frame: 24 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: October 2009
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01003548

Contacts
Contact: Jose R Alegretti, BSc 551130596113 jalegretti@huntington.com.br
Contact: Andre M Rocha, PhD 551130596122 arocha@huntington.com.br

Locations
Brazil
Departamento de Ginecologia Recruiting
Sao Paulo, Brazil, 04023-900
Contact: Jose R Alegretti, BSc     551130596113     jalegretti@huntington.com.br    
Contact: Andre M Rocha, PhD     551130596122     arocha@huntington.com.br    
Principal Investigator: Eduardo LA Motta, MD, PhD            
Sponsors and Collaborators
Federal University of São Paulo
Incept Biosystems
Investigators
Study Chair: Eduardo LA Motta, MD, PhD Department of Gynecology - Universidade Federal de Sao Paulo
  More Information

No publications provided

Responsible Party: José Roberto Alegretti, Universidade Federal de São Paulo
ClinicalTrials.gov Identifier: NCT01003548     History of Changes
Other Study ID Numbers: 0405/08
Study First Received: October 27, 2009
Last Updated: October 27, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Embryo culture
IVF
Microfluidics
infertility

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 19, 2013