Viewing Study NCT01194531



Ignite Creation Date: 2024-05-05 @ 10:48 PM
Last Modification Date: 2024-10-26 @ 10:24 AM
Study NCT ID: NCT01194531
Status: TERMINATED
Last Update Posted: 2014-11-25
First Post: 2010-08-02

Brief Title: Impact of Parental Support on Pregnancy Outcomes IPSO Trial- Day 3 Preimplantation Genetic Screening PGS With Day 5 Fresh Transfer
Sponsor: Natera Inc
Organization: Natera Inc

Study Overview

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
Status: TERMINATED
Status Verified Date: 2014-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Slow enrollment and Natera is transitioning to a new PGS testing platform
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: IPSO
Brief Summary: 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
Detailed Description: 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 armor 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None