Embryo Selection Using Non-invasive Metabolomic Analysis Versus Morphology - Full Text View

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:

Scott R, Seli E, Miller K, Sakkas D, Scott K, Burns DH. Noninvasive metabolomic profiling of human embryo culture media using Raman spectroscopy predicts embryonic reproductive potential: a prospective blinded pilot study. Fertil Steril. 2008 Jul;90(1):77-83. Epub 2008 Feb 20.

Seli E, Botros L, Sakkas D, Burns DH. Noninvasive metabolomic profiling of embryo culture media using proton nuclear magnetic resonance correlates with reproductive potential of embryos in women undergoing in vitro fertilization. Fertil Steril. 2008 Dec;90(6):2183-9. Epub 2008 Oct 8.

Seli E, Sakkas D, Scott R, Kwok SC, Rosendahl SM, Burns DH. Noninvasive metabolomic profiling of embryo culture media using Raman and near-infrared spectroscopy correlates with reproductive potential of embryos in women undergoing in vitro fertilization. Fertil Steril. 2007 Nov;88(5):1350-7. Epub 2007 Oct 17.

Seli E, Vergouw CG, Morita H, Botros L, Roos P, Lambalk CB, Yamashita N, Kato O, Sakkas D. Noninvasive metabolomic profiling as an adjunct to morphology for noninvasive embryo assessment in women undergoing single embryo transfer. Fertil Steril. 2010 Jul;94(2):535-42. Epub 2009 Jul 8.

Responsible Party:	Eugonia
ClinicalTrials.gov Identifier:	NCT01490515 History of Changes
Other Study ID Numbers:	metabolomics
Study First Received:	December 9, 2011
Last Updated:	December 12, 2011
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 June 17, 2013