Embryo Selection Using Non-invasive Metabolomic Analysis Versus Morphology

NCT01490515 | Completed Phase 4

• 1 other identifier: metabolomics
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Embryo Viability

Keywords

non-invasive,; metabolomics,; morphology,; embryo selection,; implantation rates

Outcome Measures

Primary Outcomes (1)

• Implantation rates

  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.

  6 weeks of pregnancy

Study Arms (2)

Morphology embryo evaluation

ACTIVE COMPARATOR

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

non-invasive metabolomic profiling

EXPERIMENTAL

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

Interventions

non-invasive metabolomic profiling PROCEDURE

non-invasive metabolomic profiling of IVF human embryos

Also known as: ViaMetrics-E, Molecular Biometrics

non-invasive metabolomic profiling

morphological evaluation OTHER

Simple microscopic observation of embryos and evaluation of morphological characteristics

Morphology embryo evaluation

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients with at least 4 fertilized oocytes

You may not qualify if:

• patients with less that 4 fertilized oocytes

Sponsors & Collaborators

• Eugonia: lead

Study Sites (1)

Eugonia ART Unit

Athens, Attica, 16561, Greece

Location

Related Publications (5)

• 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. doi: 10.1016/j.fertnstert.2007.11.058. Epub 2008 Feb 20.

  PMID: 18281045 BACKGROUND

• 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. doi: 10.1016/j.fertnstert.2008.07.1739. Epub 2008 Oct 8.

  PMID: 18842260 BACKGROUND

• 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. doi: 10.1016/j.fertnstert.2007.07.1390. Epub 2007 Oct 17.

  PMID: 17923129 BACKGROUND

• 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. doi: 10.1016/j.fertnstert.2009.03.078. Epub 2009 Jul 8.

  PMID: 19589524 BACKGROUND

• Sfontouris IA, Lainas GT, Sakkas D, Zorzovilis IZ, Petsas GK, Lainas TG. Non-invasive metabolomic analysis using a commercial NIR instrument for embryo selection. J Hum Reprod Sci. 2013 Apr;6(2):133-9. doi: 10.4103/0974-1208.117174.

  PMID: 24082655 DERIVED

Study Officials

• Ioannis Sfontouris, PhD

  Eugonia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2011
• First Posted: December 13, 2011
• Study Start: April 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 16, 2013

Record last verified: 2011-12

Locations

GR (1)