Ignite Creation Date:
2024-05-06 @ 12:18 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01546324
Status:
COMPLETED
Last Update Posted:
2013-08-12
First Post:
2012-02-24
Brief Title:
Collection of Maternal Blood Samples for Development of Non-invasive Prenatal Diagnostic Testing
Sponsor:
Natera Inc
Organization:
Natera Inc
Study Overview
Official Title:
Prenatal Diagnosis of Fetal DNA Isolated From Maternal Plasma
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to collect blood samples from pregnant women who achieved pregnancy following in-vitro fertilization IVF with Nateras preimplantation aneuploidy screening with or without single gene gene testing These samples will be used for test development of non-invasive prenatal diagnostic testing
Detailed Description:
Eligible subjects will sign a consent form and have blood drawn at approximately 8-17 weeks gestation Subjects will received 200 reimbursement for providing this blood sample The collected samples will be used to help develop non-invasive prenatal diagnostic testing using Nateras Parental Support technology which is already commercialized for genetic diagnosis of in-vitro embryos In this study the technology will be tested for its ability to analyze fetal-specific pieces of DNA isolated from the mothers blood No results of the maternal blood testing will be reported to the subject or to their physicians
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