Embryo Selection Using Non-invasive Metabolomic Analysis Versus Morphology

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eugonia
ClinicalTrials.gov Identifier:
NCT01490515
First received: December 9, 2011
Last updated: December 13, 2013
Last verified: December 2011
  Purpose

Metabolomics was recently introduced in human IVF for non-invasive identification of viable embryos with the highest developmental competence. The investigators intended to investigate if embryo assessment using non-invasive metabolomic profiling leads to increased implantation rates compared to routine morphology evaluation alone.


Condition Intervention Phase
Embryo Viability
Procedure: non-invasive metabolomic profiling
Other: morphological evaluation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Embryo Selection Using Non-invasive Metabolomic Analysis Indicates Improvement in Implantation Rates With Fetal Cardiac Activity

Further study details as provided by Eugonia:

Primary Outcome Measures:
  • Implantation rates [ Time Frame: 6 weeks of pregnancy ] [ Designated as safety issue: No ]
    To compare non-invasive metabolomic profiling and the traditional method of morphology assessment for embryo selection in terms of implantation and pregnancy rates in a clinical IVF program.


Enrollment: 125
Study Start Date: April 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Morphology embryo evaluation
To compare non-invasive metabolomic profiling and the traditional method of morphology assessment for embryo selection in terms of implantation and pregnancy rates in a clinical IVF program.
Other: morphological evaluation
Simple microscopic observation of embryos and evaluation of morphological characteristics
Experimental: non-invasive metabolomic profiling
To compare non-invasive metabolomic profiling and the traditional method of morphology assessment for embryo selection in terms of implantation and pregnancy rates in a clinical IVF program.
Procedure: non-invasive metabolomic profiling
non-invasive metabolomic profiling of IVF human embryos
Other Name: ViaMetrics-E, Molecular Biometrics

Detailed Description:

Metabolomics was recently introduced in human IVF for non-invasive identification of viable embryos with the highest developmental competence. The aim of the present study was to determine whether embryo selection using non-invasive metabolomic profiling as an adjunct to morphology leads to increased implantation rates compared to routine morphology evaluation alone.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients with at least 4 fertilized oocytes

Exclusion Criteria:

  • patients with less that 4 fertilized oocytes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490515

Locations
Greece
Eugonia ART Unit
Athens, Attiki, Greece, 16561
Sponsors and Collaborators
Eugonia
Investigators
Principal Investigator: Ioannis Sfontouris, PhD Eugonia
  More Information

Publications:
Responsible Party: Eugonia
ClinicalTrials.gov Identifier: NCT01490515     History of Changes
Other Study ID Numbers: metabolomics
Study First Received: December 9, 2011
Last Updated: December 13, 2013
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by Eugonia:
non-invasive,
metabolomics,
morphology,
embryo selection,
implantation rates

ClinicalTrials.gov processed this record on April 14, 2014