- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01490515
Embryo Selection Using Non-invasive Metabolomic Analysis Versus Morphology
December 13, 2013 updated by: Eugonia
Embryo Selection Using Non-invasive Metabolomic Analysis Indicates Improvement in Implantation Rates With Fetal Cardiac Activity
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
125
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Attiki
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Athens, Attiki, Greece, 16561
- Eugonia ART Unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 49 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- patients with at least 4 fertilized oocytes
Exclusion Criteria:
- patients with less that 4 fertilized oocytes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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Simple microscopic observation of embryos and evaluation of morphological characteristics
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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.
|
non-invasive metabolomic profiling of IVF human embryos
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implantation rates
Time Frame: 6 weeks of pregnancy
|
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.
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6 weeks of pregnancy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ioannis Sfontouris, PhD, Eugonia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1016/j.fertnstert.2007.11.058. 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. doi: 10.1016/j.fertnstert.2008.07.1739. 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. doi: 10.1016/j.fertnstert.2007.07.1390. 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. doi: 10.1016/j.fertnstert.2009.03.078. Epub 2009 Jul 8.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
December 9, 2011
First Submitted That Met QC Criteria
December 12, 2011
First Posted (Estimate)
December 13, 2011
Study Record Updates
Last Update Posted (Estimate)
December 16, 2013
Last Update Submitted That Met QC Criteria
December 13, 2013
Last Verified
December 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- metabolomics
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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