Polar Body Biopsy for Preimplantation Genetic Screening

Aneuploidy Clinical Trial

— Polar Body  

Official title:

Polar Body Biopsy (PB) for Preimplantation Genetic Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01574404
• Other study ID #: 0911010734
• Status: Completed
• Phase: N/A
• First received: March 16, 2012
• Last updated: June 10, 2015
• Start date: September 2011
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2014
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 42 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Aneuploidy

Intervention

Procedure:
• Polar body biopsy with PGS
PB biopsy and analysis by comparing the PB results to the FISH/microarray results

Locations

Country	Name	City	State
United States	Ronald O. Perelmand and Claudia Cohen Center for Reproductive Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety of polar biopsy	To evaluate the safety of polar biopsy by comparing the implantation, miscarriage, pregnancy, and delivery rates	1 year	Yes

External Links

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