Embryo Development in Microfluidics System of Culture

Infertility Clinical Trial

Official title:

Comparison of the in Vitro Development of Human Embryos in Static and and Microfluidics Systems of Culture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01003548
• Other study ID #: 0405/08
• Status: Recruiting
• Phase: Phase 2
• First received: October 27, 2009
• Last updated: October 27, 2009
• Start date: October 2009
• Est. completion date: October 2011

Study information

• Verified date: October 2009
• Source: Federal University of São Paulo
• Contact: Jose R Alegretti, BSc
• Phone: 551130596113
• Email: jalegretti[@]huntington.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: October 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Infertility

Intervention

Device:
• SMART dynamic system of embryo culture
Embryos will be cultured in a dynamic system of microfluidics.
• Static culture
Embryos cultured in 40 microliters microdrops of G-IVF plus series V

Locations

Country	Name	City	State
Brazil	Departamento de Ginecologia	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Incept Biosystems

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Embryo morphology on days 2 and 3 of embryo culture according to the criteria described by Lucinda Veeck		Embryo culture for 3 days before transference to the uterus	No
Secondary	Implantation rate and pregnancy rate		24 month	No