Improving IVF Embryo Quality Grading Using Polarized Light

NCT01601249 | Withdrawn Phase 1

• 1 other identifier: 008212- HMO-CTIL
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

IVF, embryo selection, polarized light

Outcome Measures

Primary Outcomes (1)

• Occurrence of clinical pregnancy

  within 2 weeks after ET

Secondary Outcomes (1)

• Live birth

  up to 40 weeks

Study Arms (2)

Polscope based embryo grading

EXPERIMENTAL

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

Morphology based embryo grading

ACTIVE COMPARATOR

Conventional embryo grading and decision making

Procedure: Embryo selection based on polscope grading or morphology

Interventions

Embryo selection based on polscope grading or morphology 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; Polscope based embryo grading

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah University Hospital

Jerusalem, Israel

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Yoel Shufaro, MD PhD

  HMO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 17, 2012
• Study Start: September 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 20, 2015

Record last verified: 2012-05

Locations

IL (1)