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Polar Body Biopsy for Preimplantation Genetic Screening

Polar Body Biopsy (PB) for Preimplantation Genetic Screening

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01574404
Acronym
Polar Body
Enrollment
33
Registered
2012-04-10
Start date
2011-09-30
Completion date
2014-12-31
Last updated
2015-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneuploidy

Keywords

PGS,PGD, IVF, Polar Body Biopsy, FISH, Microarray analysis

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

Interventions

PROCEDUREPolar body biopsy with PGS

PB biopsy and analysis by comparing the PB results to the FISH/microarray results

Sponsors

Weill Medical College of Cornell University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 42 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of polar biopsy and preimplantation genetic analysis1 yearTo determine the efficacy of PB biopsy and analysis by comparing the PB results to the FISH/microarray results

Secondary

MeasureTime frameDescription
Safety of polar biopsy1 yearTo evaluate the safety of polar biopsy by comparing the implantation, miscarriage, pregnancy, and delivery rates

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026