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WithdrawnNCT01601249Updated Aug 20, 2015

Improving IVF Embryo Quality Grading Using Polarized Light

A Phase 1 interventional study of Embryo selection based on polscope grading or morphology in Infertility, sponsored by Hadassah Medical Organization. Withdrawn at 1 site in Israel. Open to female participants aged 18 Years to 38 Years. Per ClinicalTrials.gov, last updated 2015-08-20.

Sponsored by Hadassah Medical Organization · Phase 1 and Interventional

Why this study was withdrawn
PI moved from Hadassah
Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 38 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Infertility

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Keywords

  • IVF, embryo selection, polarized light
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

Browse Infertility studies →

Lead sponsor

Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 38 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18-38, (near) normal MF, normal uterus, >4 aspirated oocytes, intent to transfer 1-2 embryos.

Exclusion criteria

Exclusion Criteria:

  • Severe MF problems, uterine anomalies, PGD, RIF.
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

  • Active comparator
    Morphology based embryo grading

    Conventional embryo grading and decision making

    Procedure: Embryo selection based on polscope grading or morphology

Interventions

  • ProcedureEmbryo 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.

06

What researchers measure

Primary outcomes

  1. Occurrence of clinical pregnancy

    Time frame: within 2 weeks after ET

Secondary outcomes

  1. Live birth

    Time frame: up to 40 weeks

07

Study locations

1 site
  • Hadassah University Hospital
    Jerusalem, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01601249
Lead sponsor
Hadassah Medical Organization
Responsible party
Sponsor
First posted
May 17, 2012
Start date
Sep 2012
Primary completion
Aug 2015
Completion
Aug 2015
Last update
Aug 20, 2015

Study contacts

Yoel Shufaro, MD PhD
principal investigator · HMO

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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