Ignite Creation Date:
2024-05-06 @ 7:15 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02502214
Status:
UNKNOWN
Last Update Posted:
2017-05-19
First Post:
2015-07-16
Brief Title:
Feasibility Study of Preimplantation Genetic Diagnosis for Single-gene Disorders
Sponsor:
University Hospital Strasbourg France
Organization:
University Hospital Strasbourg France
Study Overview
Official Title:
Feasibility Study of Preimplantation Genetic Diagnosis for Single-gene Disorders by Using Nextgeneration Sequencing
Status:
UNKNOWN
Status Verified Date:
2017-05
Last Known Status:
RECRUITING
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:
Preimplantation Genetic Diagnosis PGD for monogenic diseases is usually performed by multiplex PCR combining polymorphic microsatellites familial analysis and where possible couple-specific mutation detection Single-cell multiplex PCR developments are costly and time-consuming We propose to test and clinically validate a targeted next-generation sequencing approach for the PGD for cystic fibrosis This technique would allow a PGD for probably almost every couple asking for it in our centre without a previous couple-specific development but only a preliminary familial analysis It will be based on haplotyping using a large number of SNPs and mutation detection A clinical validation will be performed by reanalysing non-transferable embryos obtained after PGD for cystic fibrosis with couples informed consent Concordance of the results between PGD and reanalysis by NGS will be achieved and if validated this technique may be applied to future PGD for cystic fibrosis in our centre The same technique may then be applied for other PGD indications for which a set-up is often needed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None