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Improving IVF Embryo Quality Grading Using Polarized Light

This study is not yet open for participant recruitment.
Verified May 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01601249
First received: May 3, 2012
Last updated: May 16, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Infertility
 Procedure: Embryo selection based on polscope grading or morphology
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Prospective Comparison Between Conventional IVF Embryo Grading and Polscope Based Grading

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Occurrence of clinical pregnancy [ Time Frame: within 2 weeks after ET ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Live birth [ Time Frame: up to 40 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01601249

Contacts
Contact: Yoel Shufaro, MD PhD yoel.shufaro@gmail.com

Locations
Israel
Hadassah University Hospital Not yet recruiting
Jerusalem, Israel
Contact: Yoel Shufaro         yoel.shufaro@gmail.com    
Principal Investigator: Yoel Shufaro, MD PhD            
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Yoel Shufaro, MD PhD HMO
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01601249     History of Changes
Other Study ID Numbers: 008212- HMO-CTIL
Study First Received: May 3, 2012
Last Updated: May 16, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
IVF, embryo selection, polarized light

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 23, 2013