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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00773825 |
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 |
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Natural Pregnancy Pregnancy After IVF, ICSI, Ovarian Stimulation) |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Assessment of the Risk of Imprinting Defects in Children Born Following Assisted Reproductive Technologies (ART) |
whole blood (serum, ADN) and placenta samples
Estimated Enrollment: | 900 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Pregnancy after ICSI or IVF
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2
Pregnancy after ovarian stimulation
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3
natural pregnancy
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Methodology: assessment of the methylation status at 9 different imprinted loci (using Southern blot and methyl-specific quantitative PCR) in 3 groups of patients: 300 children naturally conceived, 300 children conceived after ovarian stimulation but with in vivo fertilization, and 300 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 5 APHP maternity hospitals associated with ART departments ( ANTOINE BECLERE HOSPITAL, Cochin HOSPITAL, Saint-Vincent de Paul HOSPITAL, Jean VERDIER HOSPITAL et Tenon HOSPITAL) during a 3 years period.
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.
Ages Eligible for Study: | 26 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Women followed in a participating ART departments
Inclusion Criteria:
Mother :
Exclusion Criteria:
Contact: Yves LE BOUC, Professor | +33(0) 1 44 73 64 47 | yves.lebouc@trs.aphp.fr |
France | |
Trousseau Hospital | Recruiting |
Paris, France, 75012 | |
Contact: Yves Le Bouc, Professor yves.lebouc@trs.aphp.fr | |
Contact: Sylvie Rossignol, PhD, MD sylvie.rossignol@trs.aphp.fr | |
Principal Investigator: Yves Le Bouc, Professor |
Principal Investigator: | Yves Le BOUC, PUPH | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Department Clinical Reseach of Developpement ( Christophe Aucan ) |
Study ID Numbers: | P040440, AOM04019, ENR2006/0205 |
Study First Received: | October 15, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00773825 |
Health Authority: | France: Direction Générale de la Santé |
Genomic imprinting Reproductive techniques, assisted Beckwith-Wiedemann syndrome Angelman syndrome |
Angelman syndrome Angelman Syndrome |