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Genomic Imprinting and Assisted Reproductive Technologies (EPIGEN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00773825
First Posted: October 16, 2008
Last Update Posted: June 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
October 15, 2008
October 16, 2008
June 18, 2015
February 2007
June 2015   (Final data collection date for primary outcome measure)
Assessment of the methylation status at 9 imprinted loci in cord blood collected just after birth. [ Time Frame: At the birth ]
Same as current
Complete list of historical versions of study NCT00773825 on ClinicalTrials.gov Archive Site
Assessment of other epigenetic marks (histone modifications) at imprinted loci and at non imprinted but epigenetically regulated loci. [ Time Frame: At the birth ]
Same as current
Not Provided
Not Provided
 
Genomic Imprinting and Assisted Reproductive Technologies
Assessment of the Risk of Imprinting Defects in Children Born Following Assisted Reproductive Technologies (ART)
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.

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
whole blood (serum, ADN) and placenta samples
Non-Probability Sample
Women followed in a participating ART departments
  • Natural Pregnancy
  • Pregnancy, Ovarian
Not Provided
  • 1
    Pregnancy after ICSI or IVF
  • 2
    Pregnancy after ovarian stimulation
  • 3
    natural pregnancy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
542
June 2015
June 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Mother :

  • Age: 26 to 40 at conception
  • Single foetus pregnancy
  • Signed informed consent
  • Affiliation to French health benefits
  • Absence of maternal pathology
  • Normal foetal karyotype (if available)
  • Known procedure of ovarian stimulation
  • ART procedure without sperm or oocyte donation
  • ART in a participating ART departments
  • Delivery in a participating hospital

Father

  • Age : 18 to 50 at conception
  • Signed informed consent

Exclusion Criteria:

  • Abnormal foetal karyotype (if available)
  • Delivery before 35 weeks of amenorrhea
  • Delivery in not participating hospital
  • Delivery complication leading to the absence of sample collection
Sexes Eligible for Study: Female
26 Years to 40 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00773825
P040440
No
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Yves Le BOUC, PUPH Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
June 2015