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Polar Body Biopsy for Preimplantation Genetic Screening (Polar Body)

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.
 
ClinicalTrials.gov Identifier: NCT01574404
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : June 11, 2015
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Aneuploidy Procedure: Polar body biopsy with PGS Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Polar Body Biopsy (PB) for Preimplantation Genetic Screening
Study Start Date : September 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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




Primary Outcome Measures :
  1. Efficacy of polar biopsy and preimplantation genetic analysis [ Time Frame: 1 year ]
    To determine the efficacy of PB biopsy and analysis by comparing the PB results to the FISH/microarray results


Secondary Outcome Measures :
  1. Safety of polar biopsy [ Time Frame: 1 year ]
    To evaluate the safety of polar biopsy by comparing the implantation, miscarriage, pregnancy, and delivery rates



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

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): NCT01574404


Locations
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United States, New York
Ronald O. Perelmand and Claudia Cohen Center for Reproductive Medicine
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Glenn Schattman Weill Medical College of Cornell University
Additional Information:
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01574404    
Other Study ID Numbers: 0911010734
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: June 2015
Keywords provided by Weill Medical College of Cornell University:
PGS,PGD, IVF, Polar Body Biopsy, FISH, Microarray analysis
Additional relevant MeSH terms:
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Aneuploidy
Chromosome Aberrations
Pathologic Processes