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

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ClinicalTrials.gov Identifier: NCT02171884
Recruitment Status : Completed
First Posted : June 24, 2014
Last Update Posted : March 26, 2024
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Study Description
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Brief Summary:

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.

Condition or disease Intervention/treatment
Assisted Reproductive Technology Freezing/Thawing Procedure Prolonged Culture Procedure Other: Sample of cord blood Other: Sample of placenta

Study Design
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Study Type : Observational
Actual Enrollment : 298 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of the Impact of Freezing-thawing Procedures and the Prolonged Culture of Embryos on Epigenetic Regulation in Humans
Actual Study Start Date : January 17, 2013
Actual Primary Completion Date : May 2, 2022
Actual Study Completion Date : May 2, 2022
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Analysis of the expression of 3 transposable elements (HERV-K, LINE-1 and ALU) [ Time Frame: Baselines ]
    DNA / RNA extraction

  3. Level of methylation and the level of expression of Genomic Imprinting (GI) and Transposable Elements (TE) [ Time Frame: Baselines ]
    DNA / RNA extraction


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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)
Criteria

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
Contacts and Locations
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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): NCT02171884


Locations
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France
CHU de BESANCON
Besancon, France, 25030
CHU de DIJON
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02171884    
Other Study ID Numbers: FAUQUE DB 2013
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: March 26, 2024
Last Verified: March 2024