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Embryo Selection Using Non-invasive Metabolomic Analysis Versus Morphology

NCT ID: NCT01490515

Last Updated: 2013-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Embryo Viability

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

morphological evaluation

Intervention Type OTHER

Simple microscopic observation of embryos and evaluation of morphological characteristics

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.

Group Type EXPERIMENTAL

non-invasive metabolomic profiling

Intervention Type PROCEDURE

non-invasive metabolomic profiling of IVF human embryos

Interventions

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non-invasive metabolomic profiling

non-invasive metabolomic profiling of IVF human embryos

Intervention Type PROCEDURE

morphological evaluation

Simple microscopic observation of embryos and evaluation of morphological characteristics

Intervention Type OTHER

Other Intervention Names

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ViaMetrics-E, Molecular Biometrics

Eligibility Criteria

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Inclusion Criteria

* patients with at least 4 fertilized oocytes

Exclusion Criteria

* patients with less that 4 fertilized oocytes
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eugonia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ioannis Sfontouris, PhD

Role: PRINCIPAL_INVESTIGATOR

Eugonia

Locations

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Eugonia ART Unit

Athens, Attica, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 18281045 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18842260 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17923129 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19589524 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24082655 (View on PubMed)

Other Identifiers

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metabolomics

Identifier Type: -

Identifier Source: org_study_id