Embryo ViabilityPhase 4NCT01490515
Embryo Selection Using Non-invasive Metabolomic Analysis Versus Morphology
A Phase 4 study testing non-invasive metabolomic profiling and morphological evaluation in people with Embryo Viability, run by Eugonia at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Embryo Viability
- What is being tested?
- non-invasive metabolomic profiling and morphological evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2010to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with at least 4 fertilized oocytes
Who cannot join
- patients with less that 4 fertilized oocytes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Embryo Viability
- Being tested
- non-invasive metabolomic profiling, morphological evaluation
- Keywords
- non-invasive,, metabolomics,, morphology,, embryo selection,, implantation rates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive metabolomic profilingProcedure or surgery
Also called ViaMetrics-E, Molecular Biometrics
non-invasive metabolomic profiling of IVF human embryos
morphological evaluationOther
Simple microscopic observation of embryos and evaluation of morphological characteristics
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: non-invasive metabolomic profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startApr 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Embryo ViabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eugonia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ioannis Sfontouris, PhD, Principal investigator, Eugonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490515
- Sponsor's protocol ID
- metabolomics
- Status last verified
- Dec 2011
- First submitted
- 9 Dec 2011
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18281045Seli 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.
PubMed 18842260Seli 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.
PubMed 17923129Seli 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.
PubMed 19589524Sfontouris 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.
PubMed 24082655
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embryo Selection Using Non-invasive Metabolomic Analysis Indicates Improvement in Implantation Rates With Fetal Cardiac Activity
- ClinicalTrials.gov ID
- NCT01490515
- Acronym / sponsor ID
- metabolomics
- Conditions
- Embryo Viability
- Keywords
- non-invasive,, metabolomics,, morphology,, embryo selection,, implantation rates
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- EugoniaUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphology embryo evaluation | Active comparator | Other: morphological evaluationTo 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 | Experimental | Procedure: non-invasive metabolomic profilingTo 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with at least 4 fertilized oocytes
Key exclusion criteria (1 listed)
- patients with less that 4 fertilized oocytes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive metabolomic profilingAlso: ViaMetrics-E, Molecular Biometricsnon-invasive metabolomic profiling of IVF human embryos | Procedure or surgery | non-invasive metabolomic profiling |
| morphological evaluationSimple microscopic observation of embryos and evaluation of morphological characteristics | Other | Morphology embryo evaluation |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
- Background: PubMed 18281045Scott 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.
- Background: PubMed 18842260Seli 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.
- Background: PubMed 17923129Seli 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.
- Background: PubMed 19589524Seli 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.
- Derived from this study: PubMed 24082655Sfontouris 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ioannis Sfontouris, PhD principal investigator
Eugonia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing non-invasive metabolomic profiling and morphological evaluation in people with Embryo Viability, run by Eugonia at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation rates (time frame: 6 weeks of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01490515, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2013; AzTrials last refreshed its copy on 2 Nov 2026.