Polar Body Biopsy for Preimplantation Genetic Screening (Polar Body)

Polar Body Biopsy (PB) for Preimplantation Genetic Screening

People with infertility undergoing in vitro fertilization (IVF) can test the embryos using a method called preimplantation genetic screening (PGS) before they are implanted in the uterus to possibly increase their chances of having a successful pregnancy. One or more cells are removed from the embryo. The chromosomes inside the cells are then tested to identify normal or aneuploid embryo(s).

The investigators propose to evaluate a test called micro array analysis on the chromosomes of the first polar body. This method tests part of the egg that would normally be lost and may help us choose the embryo most likely to become a healthy baby.

Study Overview

• Status: Completed
• Conditions: Aneuploidy
• Intervention / Treatment: Procedure: Polar body biopsy with PGS

Detailed Description

The polar body (PB) technique makes use of the 23 chromosomes contained in the first polar body, a part of the egg that is extruded at ovulation. Normally the first polar body disintegrates. However, it can be salvaged by polar body biopsy prior to this so that the chromosomes within can be analyzed. PB has three distinct advantages over conventional Fluorescent in-situ Hybridization (FISH) analysis. First, the polar body biopsy is performed on the day that the oocyte is retrieved (day 0) rather than day 3 so results are available earlier. Secondly, this methodology does not remove cells from the growing embryo. The polar body biopsy removes genetic material that would otherwise degrade. Finally, microarray analysis evaluates all 23 chromosomes while only 9-10 chromosomes can be studied with FISH analysis.

The investigators propose to perform microarray analysis in 50 IVF/ICSI (intracytoplasmic sperm injection) patients undergoing PGS.

Day 0 ICSI; PB* Day 1 Day 2 Day 3 Embryo biopsy with FISH or Microarray analysis Day 4 Day 5 Embryo transfer or embryo biopsy with Microarray analysis followed by Embryo Cryopreservation

Polar body biopsies will be frozen and later analyzed, The PB results will remain undisclosed until the end of the study period. PB results will not be used to guide treatment or clinical management. Embryos will be chosen or deselected for transfer solely based on the standard of care treatment aneuploidy screening analysis.

The three specific aims of the project are as follows:

• To determine the efficacy of PB biopsy and analysis by comparing the PB results to the Fluorescent in-situ Hybridization (FISH)/microarray results
• To evaluate the safety of PB by comparing the implantation , miscarriage, pregnancy, and delivery rates
• To determine the error rate of FISH analysis by analyzing the remaining cells in embryos determined to be abnormal by initial FISH/microarray analysis

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Ronald O. Perelmand and Claudia Cohen Center for Reproductive Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Are undergoing IVF/Intracytoplasmic sperm injection(ICSI)
2. Are considering preimplantation genetic screening for aneuploidy
3. Are between ages 18 and 42 inclusive (female partner)

Exclusion Criteria:

1. Using sperm from a testicular source
2. Fewer than 10 oocytes retrieved
3. Fewer than 6 oocytes fertilized normally
4. Complete fertilization failure (no oocytes fertilize)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polar Body Biopsy with PGS; Polar Body Biopsy with Pre implantation genetic screening	Procedure: Polar body biopsy with PGS; PB biopsy and analysis by comparing the PB results to the FISH/microarray results

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of polar biopsy and preimplantation genetic analysis	To determine the efficacy of PB biopsy and analysis by comparing the PB results to the FISH/microarray results	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of polar biopsy	To evaluate the safety of polar biopsy by comparing the implantation, miscarriage, pregnancy, and delivery rates	1 year

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Glenn Schattman, Weill Medical College of Cornell University

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 16, 2012
• First Submitted That Met QC Criteria: April 6, 2012
• First Posted (Estimate): April 10, 2012

Study Record Updates

• Last Update Posted (Estimate): June 11, 2015
• Last Update Submitted That Met QC Criteria: June 10, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: PGS,PGD, IVF, Polar Body Biopsy, FISH, Microarray analysis
• Additional Relevant MeSH Terms: Pathologic Processes; Chromosome Aberrations; Aneuploidy
• Other Study ID Numbers: 0911010734