NCT01003548

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 28, 2009

Status Verified

October 1, 2009

Enrollment Period

1 year

First QC Date

October 27, 2009

Last Update Submit

October 27, 2009

Conditions

Keywords

Embryo cultureIVFMicrofluidicsinfertility

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Implantation rate and pregnancy rate

    24 month

Study Arms (2)

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

Embryos will be cultured in a dynamic system of microfluidics.

Smart plataform

Embryos cultured in 40 microliters microdrops of G-IVF plus series V

Static culture

Eligibility Criteria

Age21 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Use of epididimary or testicular sperm
  • Sperm or egg donation
  • Untreated systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departamento de Ginecologia

São Paulo, São Paulo, 04023-900, Brazil

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Eduardo LA Motta, MD, PhD

    Department of Gynecology - Universidade Federal de Sao Paulo

    STUDY CHAIR

Central Study Contacts

Jose R Alegretti, BSc

CONTACT

Andre M Rocha, PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2009

First Posted

October 28, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2011

Last Updated

October 28, 2009

Record last verified: 2009-10

Locations