Aneuploidy Clinical Trial
— Polar BodyOfficial title:
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 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.
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) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Ronald O. Perelmand and Claudia Cohen Center for Reproductive Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University |
United States,
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 |
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