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Polar Body Biopsy for Preimplantation Genetic Screening (Polar Body)

Primary Purpose

Aneuploidy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Polar body biopsy with PGS
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Aneuploidy focused on measuring PGS,PGD, IVF, Polar Body Biopsy, FISH, Microarray analysis

Eligibility Criteria

18 Years - 42 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Ronald O. Perelmand and Claudia Cohen Center for Reproductive Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Polar Body Biopsy with PGS

Arm Description

Polar Body Biopsy with Pre implantation genetic screening

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Safety of polar biopsy
To evaluate the safety of polar biopsy by comparing the implantation, miscarriage, pregnancy, and delivery rates

Full Information

First Posted
March 16, 2012
Last Updated
June 10, 2015
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT01574404
Brief Title
Polar Body Biopsy for Preimplantation Genetic Screening
Acronym
Polar Body
Official Title
Polar Body Biopsy (PB) for Preimplantation Genetic Screening
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneuploidy
Keywords
PGS,PGD, IVF, Polar Body Biopsy, FISH, Microarray analysis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polar Body Biopsy with PGS
Arm Type
Experimental
Arm Description
Polar Body Biopsy with Pre implantation genetic screening
Intervention Type
Procedure
Intervention Name(s)
Polar body biopsy with PGS
Intervention Description
PB biopsy and analysis by comparing the PB results to the FISH/microarray results
Primary Outcome Measure Information:
Title
Efficacy of polar biopsy and preimplantation genetic analysis
Description
To determine the efficacy of PB biopsy and analysis by comparing the PB results to the FISH/microarray results
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Safety of polar biopsy
Description
To evaluate the safety of polar biopsy by comparing the implantation, miscarriage, pregnancy, and delivery rates
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Are undergoing IVF/Intracytoplasmic sperm injection(ICSI) Are considering preimplantation genetic screening for aneuploidy Are between ages 18 and 42 inclusive (female partner) Exclusion Criteria: Using sperm from a testicular source Fewer than 10 oocytes retrieved Fewer than 6 oocytes fertilized normally Complete fertilization failure (no oocytes fertilize)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn Schattman
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ronald O. Perelmand and Claudia Cohen Center for Reproductive Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Links:
URL
http://ivf.org
Description
Related Info

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