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Improving IVF Embryo Quality Grading Using Polarized Light

This study has been withdrawn prior to enrollment.
(PI moved from Hadassah)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01601249
First Posted: May 17, 2012
Last Update Posted: August 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hadassah Medical Organization
  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: None (Open Label)
Official Title: A Prospective Comparison Between Conventional IVF Embryo Grading and Polscope Based Grading

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Occurrence of clinical pregnancy [ Time Frame: within 2 weeks after ET ]

Secondary Outcome Measures:
  • Live birth [ Time Frame: up to 40 weeks ]

Enrollment: 0
Study Start Date: September 2012
Study Completion Date: August 2015
Primary Completion Date: August 2015 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01601249


Locations
Israel
Hadassah University Hospital
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Yoel Shufaro, MD PhD HMO
  More Information

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01601249     History of Changes
Other Study ID Numbers: 008212- HMO-CTIL
First Submitted: May 3, 2012
First Posted: May 17, 2012
Last Update Posted: August 20, 2015
Last Verified: May 2012

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

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