Improving IVF Embryo Quality Grading Using Polarized Light

August 19, 2015 updated by: Hadassah Medical Organization

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 1

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

  • Israel
      • Jerusalem, Israel
        • Hadassah University Hospital

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 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

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
Experimental: Polscope based embryo grading
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
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.
Active Comparator: Morphology based embryo grading
Conventional embryo grading and decision making
Procedure: Embryo selection based on polscope grading or morphology
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of clinical pregnancy
Time Frame: within 2 weeks after ET
within 2 weeks after ET

Secondary Outcome Measures

Outcome Measure
Time Frame
Live birth
Time Frame: up to 40 weeks
up to 40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Yoel Shufaro, MD PhD, HMO

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

September 1, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

May 3, 2012

First Submitted That Met QC Criteria

May 16, 2012

First Posted (Estimate)

May 17, 2012

Study Record Updates

Last Update Posted (Estimate)

August 20, 2015

Last Update Submitted That Met QC Criteria

August 19, 2015

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 008212- HMO-CTIL

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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