Genomic Imprinting and Assisted Reproductive Technologies (EPIGEN)
|Study Design:||Time Perspective: Prospective|
|Official Title:||Assessment of the Risk of Imprinting Defects in Children Born Following Assisted Reproductive Technologies (ART)|
- Assessment of the methylation status at 9 imprinted loci in cord blood collected just after birth. [ Time Frame: At the birth ] [ Designated as safety issue: No ]
- Assessment of other epigenetic marks (histone modifications) at imprinted loci and at non imprinted but epigenetically regulated loci. [ Time Frame: At the birth ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||February 2007|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Pregnancy after ICSI or IVF
Pregnancy after ovarian stimulation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773825
|Paris, France, 75012|
|Principal Investigator:||Yves Le BOUC, PUPH||Assistance Publique - Hôpitaux de Paris|