Study of the Impact of Freezing-thawing Procedures and the Prolonged Culture of Embryos on Epigenetic Regulation in Humans

March 25, 2024 updated by: Centre Hospitalier Universitaire Dijon

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:

  1. from the umbilical cord.
  2. from the placenta.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

298

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25030
        • CHU de Besançon
      • Dijon, France, 21079
        • CHU de Dijon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
Other: Sample of cord blood
Other: Sample of placenta
Group EC1
Singletons born following ART via IVF/ICSI and freezing-thawing of the embryo
Other: Sample of cord blood
Other: Sample of placenta
Group T1
Singletons conceived naturally
Other: Sample of cord blood
Other: Sample of placenta
Group E2
Singletons born following ART with IVF/ICSI (prolonged culture)
Other: Sample of cord blood
Other: Sample of placenta

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

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2013

Primary Completion (Actual)

May 2, 2022

Study Completion (Actual)

May 2, 2022

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

June 20, 2014

First Posted (Estimated)

June 24, 2014

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

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.

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