Ignite Creation Date:
2024-05-05 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00773825
Status:
COMPLETED
Last Update Posted:
2015-06-18
First Post:
2008-10-15
Brief Title:
Genomic Imprinting and Assisted Reproductive Technologies
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Assessment of the Risk of Imprinting Defects in Children Born Following Assisted Reproductive Technologies ART
Status:
COMPLETED
Status Verified Date:
2015-06
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:
EPIGEN
Brief Summary:
Genomic imprinting referring to an epigenetic marking resulting in monoallelic gene expression plays a critical role in development Recently various imprinting diseases were reported in animals Large Offspring syndrome LOS and humans Beckwith-Wiedemann syndrome BWS and Angelman syndrome AS born after ART In all cases an imprinting defect was involved loss of methylation at ICR2 in BWS at SNRPN in AS and at IGF2R DMR2 in LOS These data suggest that ART procedures may impair the establishment or the maintenance following fertilization of methylation marks at maternally imprinted loci In view of these data the aim of this study is to determine if children born following ART exhibit an increased risk of imprinting defects If the answer is yes the second objective is to identify the problematic step in the ART procedure and thus to suppress or modify this step
Detailed Description:
Methodology assessment of the methylation status at 9 different imprinted loci using Southern blot and methyl-specific quantitative PCR in 3 groups of patients 150 children naturally conceived 150 children conceived after ovarian stimulation but with in vivo fertilization and 150 children conceived after ovarian stimulation and in VITRO fertilization These analyses will be performed on cord blood Fragments of placental tissue will also be collected for further analyses Patients will be selected in maternity hospitals associated with ART departments ANTOINE BECLERE HOSPITAL Cochin HOSPITAL Saint-Vincent de Paul HOSPITAL Jean VERDIER HOSPITAL Tenon HOSPITAL and Dijon Hospital
This work is also a unique opportunity to establish a DNA RNA and tissue collection allowing further investigation regarding other epigenetic modifications than DNA methylation not only at imprinted loci but also in other genomic regions regulated by epigenetic modifications
This work is also a unique opportunity to establish a DNA RNA and tissue collection allowing further investigation regarding other epigenetic modifications than DNA methylation not only at imprinted loci but also in other genomic regions regulated by epigenetic modifications
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