Impact of Parental Support on Pregnancy Outcomes (IPSO) Trial- Day 3 Preimplantation Genetic Screening (PGS) With Day 5 Fresh Transfer (IPSO)
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.
|Preimplantation Gentic Screening (PGS) In Vitro Fertilization (IVF) Preimplantation Genetic Diagnosis (PGD)||Device: 24 Chromosome Aneuploidy Screening with Parental Support||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
|Official Title:||IPSO Trial - Impact of Parental Support on Pregnancy Outcomes: A Multi-Center, Randomized, Open-Label Study to Evaluate the Implantation and Pregnancy Rates Following 24 Chromosome Aneuploidy Screening With Parental Support in Patients Undergoing In Vitro Fertilization (IVF)|
- Implantation Rate [ Time Frame: Data is collected at approximately 4-6 weeks gestation, 20 weeks gestation and 40 weeks gestation. ]Implantation rate is defined as the ratio between the number of gestational sacs with a fetal heartbeat and the total number of embryos transferred.
|Study Start Date:||September 2010|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
No Intervention: CONTROL arm
Subjects assigned to this arm of the study will receive no PGS testing.
Subjects assigned to this arm of the study will receive PGS testing.
Device: 24 Chromosome Aneuploidy Screening with Parental Support
Preimplantation Genetic Screening (PGS)
Other Name: Preimplantation Genetic Diagnosis (PGD)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194531
|United States, California|
|Huntington Reproductive Center|
|Laguna Hills, California, United States, 92653|
|United States, District of Columbia|
|Shady Grove Fertility RSC|
|Washington, District of Columbia, United States, 20006|
|United States, Florida|
|Florida Fertility Institute/ Women's Medical Research Group, LLC|
|Clearwater, Florida, United States, 33759|
|United States, Georgia|
|Atlanta Center for Reproductive Medicine|
|Atlanta, Georgia, United States, 30328|
|United States, Illinois|
|Fertility Centers of Illinois|
|Chicago, Illinois, United States, 60610|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02451|
|United States, Nevada|
|The Nevada Center for Reproductive Medicine|
|Reno, Nevada, United States, 89511|
|United States, Pennsylvania|
|Main Line Fertility|
|Bryn Mawr, Pennsylvania, United States, 19010-3121|
|United States, Texas|
|Fertility Specialist of Houston|
|Houston, Texas, United States, 77054|