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

Completed

• Conditions: Prolonged Culture Procedure; Assisted Reproductive Technology; Freezing/Thawing Procedure
• Interventions: Other: Sample of cord blood; Other: Sample of placenta

• Registration Number: NCT02171884
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-17
• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-24
• Primary Completion: 2022-05-02
• Study Completion: 2022-05-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 298

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group EC1	Sample of cord blood	Singletons born following ART via IVF/ICSI and freezing-thawing of the embryo
Group E2	Sample of placenta	Singletons born following ART with IVF/ICSI (prolonged culture)
Group E2	Sample of cord blood	Singletons born following ART with IVF/ICSI (prolonged culture)
Group EC1	Sample of placenta	Singletons born following ART via IVF/ICSI and freezing-thawing of the embryo
Group T1	Sample of placenta	Singletons conceived naturally
Group E1	Sample of cord blood	Singletons born following ART via IVF/ICSI (short culture)
Group E1	Sample of placenta	Singletons born following ART via IVF/ICSI (short culture)
Group T1	Sample of cord blood	Singletons conceived naturally

Primary Outcome Measures

Name	Time	Method
Analysis of the expression of several genes subjected to imprinting (H19, IGF2, IGF2R, MEST, PEG3, SNRPN, IGF2, KCNQ1, GRB10 and PLAGL1)	Baselines	DNA / RNA extraction
Level of methylation and the level of expression of Genomic Imprinting (GI) and Transposable Elements (TE)	Baselines	DNA / RNA extraction
Analysis of the expression of 3 transposable elements (HERV-K, LINE-1 and ALU)	Baselines	DNA / RNA extraction

Trial Locations

Locations (2)

CHU de BESANCON; 🇫🇷 Besancon, France

CHU de DIJON; 🇫🇷 Dijon, France