Embryo Selection Using Non-invasive Metabolomic Analysis Versus Morphology

Study Overview
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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.

Official Title
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Embryo Selection Using Non-invasive Metabolomic Analysis Indicates Improvement in Implantation Rates With Fetal Cardiac Activity

Conditions
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Embryo Viability

Intervention / Treatment
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* Procedure: non-invasive metabolomic profiling
* Other: morphological evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with at least 4 fertilized oocytes Exclusion Criteria: patients with less that 4 fertilized oocytes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Morphology embryo evaluation<br>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<br>* Simple microscopic observation of embryos and evaluation of morphological characteristics<br>|
| Experimental: non-invasive metabolomic profiling<br>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<br>* non-invasive metabolomic profiling of IVF human embryos<br>* Other names: ViaMetrics-E, Molecular Biometrics;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-invasive,, metabolomics,, morphology,, embryo selection,, implantation rates