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Embryo Development in Microfluidics System of Culture

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ClinicalTrials.gov Identifier: NCT01003548
Recruitment Status : Unknown
Verified October 2009 by Federal University of São Paulo.
Recruitment status was:  Recruiting
First Posted : October 28, 2009
Last Update Posted : October 28, 2009
Sponsor:
Collaborator:
Incept Biosystems
Information provided by:
Federal University of São Paulo

Brief 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. 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 or disease Intervention/treatment Phase
Infertility Device: SMART dynamic system of embryo culture Device: Static culture Phase 2

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  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Comparison of the in Vitro Development of Human Embryos in Static and and Microfluidics Systems of Culture
Study Start Date : October 2009
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Implantation rate and pregnancy rate [ Time Frame: 24 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: José Roberto Alegretti, Universidade Federal de São Paulo
ClinicalTrials.gov Identifier: NCT01003548     History of Changes
Other Study ID Numbers: 0405/08
First Posted: October 28, 2009    Key Record Dates
Last Update Posted: October 28, 2009
Last Verified: October 2009

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

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