Embryo Development in Microfluidics System of Culture

Study Overview
=================
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.

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.

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

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Device: SMART dynamic system of embryo culture
* Device: Static culture


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rate and pregnancy rate |  | 24 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Embryo culture, IVF, Microfluidics, infertility