- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02171884
Study of the Impact of Freezing-thawing Procedures and the Prolonged Culture of Embryos on Epigenetic Regulation in Humans
For this project, 4 groups of 38 infants have been created so as to evaluate the impact of Assisted-Reproduction Technology (ART) and more particularly the two procedures classically used in ART: the freezing/thawing of embryos and prolonged embryo culture (five days of culture in appropriate in vitro conditions to allow development of the embryo) in contrast with shorter culture of only two days.
Participation consists in accepting samples to be taken at the birth of the infant:
- from the umbilical cord.
- from the placenta.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Patricia FAUQUE
- Phone Number: +33 3 80 29 35 64
- Email: patricia.fauque@chu-dijon.fr
Study Locations
-
-
-
Besancon, France, 25030
- CHU de Besancon
-
Dijon, France, 21079
- CHU de Dijon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
4 groups of infants:
- conceived naturally
- born following ART with IVF/ICSI (short culture)
- born following ART with IVF/ICSI and freezing/thawing of the embryo
- born following ART with IVF/ICSI (prolonged culture)
Description
Inclusion Criteria:
- Patients who have provided written informed consent,
- Patients with national health insurance cover,
- Maternal age at conception between 20 and 43 years,
- Paternal age at conception between 18 and 50 years,
- Singleton pregnancy
Exclusion Criteria:
---Maternal disease:
- pulmonary, cardiac
- renal and metabolic diseases (including type 1 and 2 diabetes prior to the pregnancy)
- systemic inflammatory diseases
- hypertension
- neurological diseases
- chronic hepatitis B or C
- HIV infection
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group E1
Singletons born following ART via IVF/ICSI (short culture)
|
|
Group EC1
Singletons born following ART via IVF/ICSI and freezing-thawing of the embryo
|
|
Group T1
Singletons conceived naturally
|
|
Group E2
Singletons born following ART with IVF/ICSI (prolonged culture)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analysis of the expression of several genes subjected to imprinting (H19, IGF2, IGF2R, MEST, PEG3, SNRPN, IGF2, KCNQ1, GRB10 and PLAGL1)
Time Frame: Baselines
|
DNA / RNA extraction
|
Baselines
|
Analysis of the expression of 3 transposable elements (HERV-K, LINE-1 and ALU)
Time Frame: Baselines
|
DNA / RNA extraction
|
Baselines
|
Level of methylation and the level of expression of Genomic Imprinting (GI) and Transposable Elements (TE)
Time Frame: Baselines
|
DNA / RNA extraction
|
Baselines
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FAUQUE DB 2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Assisted Reproductive Technology
-
Merck KGaA, Darmstadt, GermanyMerck Serono GmbH, Germany; Merck B.V., Netherlands; Merck A.E., Greece; Merck... and other collaboratorsCompletedAssisted Reproductive Techniques | Reproductive Technology, AssistedItaly, Russian Federation, United Kingdom, Germany, Poland, Finland, Slovakia, Netherlands, Denmark, France, Greece
-
Tu Du HospitalRecruitingAssisted Reproductive TechnologyVietnam
-
Royal Fertility Center, EgyptHawaa Fertility CenterCompletedAssisted Reproductive TechnologyEgypt
-
khalid abd aziz mohamedWithdrawnDiagnostic Value of Sperm DNA Fragmentation and Sperm Morphology for Assisted Reproduction TreatmentAssisted Reproductive TechnologyEgypt
-
Nanjing Medical UniversityCompletedAssisted Reproductive TechnologyChina
-
Jinling Hospital, ChinaCompletedUltrasonography | Assisted Reproductive TechnologyChina
-
Chengdu University of Traditional Chinese MedicineCompletedFailure After Assisted Reproductive TechnologyChina
-
Chengdu University of Traditional Chinese MedicineCompletedFailure After Assisted Reproductive TechnologyChina
-
University Hospital, Clermont-FerrandRecruitingFertility | Assisted Reproductive Technology | Vitrification | Egg DonorFrance
-
Women's Hospital School Of Medicine Zhejiang UniversityNot yet recruitingFertility Disorders | Assisted Reproductive Technology | Offspring Health
Clinical Trials on Sample of cord blood
-
Assistance Publique Hopitaux De MarseilleCompleted
-
GlaxoSmithKlineCompletedCytomegalovirus Infections | Infections, CytomegalovirusBelgium
-
University Hospital TuebingenUnknown
-
Sheba Medical CenterUnknownCord Blood Amino Acid Profile | Fetal Amino Acid Profile in Different Gestational Ages | Infant Amino Acid Profile at Day 3 and DischargeIsrael
-
Children's Oncology GroupNational Cancer Institute (NCI)RecruitingAcute Myeloid Leukemia | Acute Lymphoblastic LeukemiaUnited States
-
GlaxoSmithKlineCompletedRespiratory Syncytial Virus InfectionsPhilippines, Mexico, Thailand, Brazil, Colombia, Panama, South Africa, Argentina, Bangladesh, Malaysia
-
University Hospital, RouenRecruitingFetal Alcohol SyndromeFrance
-
Hospital Universitari Vall d'Hebron Research InstituteHospital General Universitario Gregorio Marañon; Hospital Universitario 12... and other collaboratorsUnknown
-
Bundang CHA HospitalWithdrawnCerebral PalsyKorea, Republic of