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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
  Purpose
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.

Condition
Natural Pregnancy Pregnancy, Ovarian

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Assessment of the Risk of Imprinting Defects in Children Born Following Assisted Reproductive Technologies (ART)

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Assessment of the methylation status at 9 imprinted loci in cord blood collected just after birth. [ Time Frame: At the birth ]

Secondary Outcome Measures:
  • Assessment of other epigenetic marks (histone modifications) at imprinted loci and at non imprinted but epigenetically regulated loci. [ Time Frame: At the birth ]

Biospecimen Retention:   Samples With DNA
whole blood (serum, ADN) and placenta samples

Enrollment: 542
Study Start Date: February 2007
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Pregnancy after ICSI or IVF
2
Pregnancy after ovarian stimulation
3
natural pregnancy

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   26 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women followed in a participating ART departments
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00773825


Locations
France
Trousseau Hospital
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Yves Le BOUC, PUPH Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00773825     History of Changes
Other Study ID Numbers: P040440
First Submitted: October 15, 2008
First Posted: October 16, 2008
Last Update Posted: June 18, 2015
Last Verified: June 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Genomic imprinting
Reproductive techniques, assisted
Beckwith-Wiedemann syndrome
Angelman syndrome

Additional relevant MeSH terms:
Pregnancy, Ovarian
Pregnancy, Ectopic
Pregnancy Complications