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

Study Overview
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Brief Summary
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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.

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

Conditions
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Assisted Reproductive Technology, Freezing/Thawing Procedure, Prolonged Culture Procedure

Intervention / Treatment
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* Other: Sample of cord blood
* Other: Sample of placenta


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group E1<br>Singletons born following ART via IVF/ICSI (short culture) | Other: Sample of cord blood<br> <br> Other: Sample of placenta<br> <br> |
| Group EC1<br>Singletons born following ART via IVF/ICSI and freezing-thawing of the embryo | Other: Sample of cord blood<br> <br> Other: Sample of placenta<br> <br> |
| Group T1<br>Singletons conceived naturally | Other: Sample of cord blood<br> <br> Other: Sample of placenta<br> <br> |
| Group E2<br>Singletons born following ART with IVF/ICSI (prolonged culture) | Other: Sample of cord blood<br> <br> Other: Sample of placenta<br> <br> |

What is the study measuring?
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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) | DNA / RNA extraction | Baselines | 
| Analysis of the expression of 3 transposable elements (HERV-K, LINE-1 and ALU) | DNA / RNA extraction | Baselines | 
| Level of methylation and the level of expression of Genomic Imprinting (GI) and Transposable Elements (TE) | DNA / RNA extraction | Baselines |