Polar Body Biopsy for Preimplantation Genetic Screening

Brief Title

Polar Body Biopsy for Preimplantation Genetic Screening

Official Title

Polar Body Biopsy (PB) for Preimplantation Genetic Screening

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.
    

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


Primary Outcome

Efficacy of polar biopsy and preimplantation genetic analysis

Secondary Outcome

 Safety of polar biopsy

Condition

Aneuploidy

Intervention

Polar body biopsy with PGS

Study Arms / Comparison Groups

 Polar Body Biopsy with PGS
Description:  Polar Body Biopsy with Pre implantation genetic screening

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

33

Start Date

September 2011

Completion Date

December 2014

Primary Completion Date

July 2012

Eligibility 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)
      

Gender

All

Ages

18 Years - 42 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Glenn Schattman, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01574404

Organization ID

0911010734


Responsible Party

Sponsor

Study Sponsor

Weill Medical College of Cornell University


Study Sponsor

Glenn Schattman, Principal Investigator, Weill Medical College of Cornell University


Verification Date

June 2015