Improving IVF Embryo Quality Grading Using Polarized Light

Study Overview
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Brief Summary
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Selecting one or two IVF embryos with the highest potential to implant is extremely important for the success of the treatment- obtaining pregnancies and avoiding multi-fetal gestations. The currently used IVF embryo grading method is based solely on embryo morphology (cleavage rate and fragmentation) just before the transfer, which is not very well correlated with the implantation potential of each embryo. Oocyte quality and adequacy are the most important factors determining the biological quality and implantation potential of the embryo. It impossible to grade oocytes using plain optical systems, other than maturity and gross anomalies. Polscope systems allow to visualize intra ooplasmic structures and determine their retardance, as well as that of the Zona Pellucida. The investigators hypothesize that grading embryos using the oocyte's parameters as visualized by polscope is superior to conventional morphology and correlates better with their implantation potential. Here the investigators will perform a prospective randomized controlled trial to examine this hypothesis.

Detailed Description
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Each embryo will be graded in accordance to polscope based parameters; the presence of a spindle in the oocyte, its retardance, the distance between the spindle and the PB, and the thickness and retardance of the ZP. In the experimental group the embryos for transfer will be selected based on these parameters, whereas in the control group they will be selected based on conventional morphologic criteria.

Official Title
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A Prospective Comparison Between Conventional IVF Embryo Grading and Polscope Based Grading

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Embryo selection based on polscope grading or morphology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-38, (near) normal MF, normal uterus, >4 aspirated oocytes, intent to transfer 1-2 embryos. Exclusion Criteria: Severe MF problems, uterine anomalies, PGD, RIF.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Experimental: Polscope based embryo grading<br>Embryos for transfer will be selected based on highest polscope scores, unless are not grade 1-2 by conventional morphology | Procedure: Embryo selection based on polscope grading or morphology<br>* In the experimental arm embryo grading will be performed by polscope rather than conventional morphology, and the best embryo/s for transfer will be selected by this method.<br>|
| Active Comparator: Morphology based embryo grading<br>Conventional embryo grading and decision making | Procedure: Embryo selection based on polscope grading or morphology<br>* In the experimental arm embryo grading will be performed by polscope rather than conventional morphology, and the best embryo/s for transfer will be selected by this method.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of clinical pregnancy |  | within 2 weeks after ET | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth |  | up to 40 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, embryo selection, polarized light