Polar Body Biopsy for Preimplantation Genetic Screening
| Status: | Completed |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | September 2011 |
| End Date: | December 2014 |
Polar Body Biopsy (PB) for Preimplantation Genetic Screening
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 microarray 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.
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 mircroarray 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
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)
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