Natera is recruiting patients for a research study evaluating pregnancy and implantation rates in women undergoing In Vitro Fertilization (IVF) and Preimplantation Genetic Screening (PGS). PGS is also referred to as Preimplantation Genetic Diagnosis (PGD) for aneuploidy. Healthy women undergoing IVF who are between the ages of 35 to 42 years are being recruited to participate in a randomized study. The purpose of this study is to determine whether PGS- testing of embryos created during IVF for chromosomal abnormalities, prior to transfer to the uterus- improves pregnancy and implantation rates in patients when compared to patients whose embryos are not tested. PGS will be conducted using 24 Chromosome Aneuploidy Screening with Parental Support from Natera. All subjects who qualify and enroll will receive discounted IVF medications (both TEST and CONTROL arms). If you become pregnant during the study, you will receive a small payment for providing information about your pregnancy and birth. If you are assigned to the TEST arm of the study you will receive free PGS.
If you meet the criteria below, you may be a candidate for this study. To participate in the study you must: * Be a healthy, pre-menopausal female, 35-42 years of age * Have a history of less than 3 consecutive miscarriages and no more than one failed IVF cycle * Agree to use Ferring Pharmaceutical products during stimulation * Agree to be randomly assigned to either the arm of the study receiving PGS (TEST arm)or the arm receiving no additional testing (CONTROL arm) Additional screening will be conducted to determine if you are eligible to enroll. All subjects who qualify and enroll will receive discounted IVF medications. If you become pregnant during the study, you will receive a small payment for providing information about your pregnancy and birth. If you are assigned to the TEST arm of the study you will receive free PGS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
59
Preimplantation Genetic Screening (PGS)
Huntington Reproductive Center
Laguna Hills, California, United States
Shady Grove Fertility RSC
Washington D.C., District of Columbia, United States
Florida Fertility Institute/ Women's Medical Research Group, LLC
Clearwater, Florida, United States
Atlanta Center for Reproductive Medicine
Atlanta, Georgia, United States
Fertility Centers of Illinois
Chicago, Illinois, United States
Boston IVF
Boston, Massachusetts, United States
The Nevada Center for Reproductive Medicine
Reno, Nevada, United States
Main Line Fertility
Bryn Mawr, Pennsylvania, United States
Fertility Specialist of Houston
Houston, Texas, United States
Implantation Rate
Implantation rate is defined as the ratio between the number of gestational sacs with a fetal heartbeat and the total number of embryos transferred.
Time frame: Data is collected at approximately 4-6 weeks gestation, 20 weeks gestation and 40 weeks gestation.
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