Embryo Development in Microfluidics System of Culture | NCT01003548

Studies
Embryo Development in Microfluidics System of Culture

NCT01003548

Sponsor

Federal University of São Paulo

Status

Unknown status

Last Update Posted

Oct 28, 2009Estimated

Enrollment

400Estimated

Phase

Phase 2

Conditions

Infertility

Interventions

SMART dynamic system of embryo culture
Static culture

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Oct 2010Estimated

Completion Date

Oct 2011Estimated

First Submitted Date

Oct 27, 2009

First Submission Date that Met QC Criteria

Oct 27, 2009

First Posted Date

Oct 28, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2009

Last Update Posted Date

Oct 28, 2009Estimated

Name	Class
Incept Biosystems	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Static culture	Active Comparator	Embryos individually cultured in microdrops of 40 microliters of G-IVFplus series V	Device: Static culture
Smart plataform	Experimental	Embryos culture in dynamics microfluidic culture system	Device: SMART dynamic system of embryo culture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SMART dynamic system of embryo culture	Device	Embryos will be cultured in a dynamic system of microfluidics.	Smart plataform

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
Implantation rate and pregnancy rate		24 month

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jose R Alegretti, BSc	Contact	551130596113		jalegretti@huntington.com.br
Andre M Rocha, PhD	Contact	551130596122		arocha@huntington.com.br

Overall Officials

Name	Affiliation	Role
Eduardo LA Motta, MD, PhD	Department of Gynecology - Universidade Federal de Sao Paulo	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departamento de Ginecologia	Recruiting	São Paulo	São Paulo	04023-900	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided