Improving IVF Embryo Quality Grading Using Polarized Light

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01601249
• Other study ID #: 008212- HMO-CTIL
• Status: Withdrawn
• Phase: Phase 1
• First received: May 3, 2012
• Last updated: August 19, 2015
• Start date: September 2012
• Est. completion date: August 2015

Study information

• Verified date: May 2012
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Infertility

Intervention

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.

Locations

Country	Name	City	State
Israel	Hadassah University Hospital	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of clinical pregnancy		within 2 weeks after ET	No
Secondary	Live birth		up to 40 weeks	No