Improving IVF Embryo Quality Grading Using Polarized Light

NCT ID: NCT01601249

Last Updated: 2015-08-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-08-31

Brief Summary

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

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Polscope based embryo grading

Embryos for transfer will be selected based on highest polscope scores, unless are not grade 1-2 by conventional morphology

Group Type: EXPERIMENTAL

Embryo selection based on polscope grading or morphology

Intervention Type: PROCEDURE

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.

Morphology based embryo grading

Conventional embryo grading and decision making

Group Type: ACTIVE_COMPARATOR

Embryo selection based on polscope grading or morphology

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoel Shufaro, MD PhD

Role: PRINCIPAL_INVESTIGATOR

HMO

Locations

Hadassah University Hospital

Jerusalem, , Israel

Countries

Israel

Other Identifiers

008212- HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id