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:

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

Completed

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Key information

Conditions

Assisted Reproductive Technology Freezing/Thawing Procedure Prolonged Culture Procedure

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de BESANCON, Besançon, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sample of cord blood

Other

Sample of placenta

Other

Primary outcomes

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
Analysis of the expression of 3 transposable elements (HERV-K, LINE-1 and ALU)

Time frame: Baselines

DNA / RNA extraction
Level of methylation and the level of expression of Genomic Imprinting (GI) and Transposable Elements (TE)

Time frame: Baselines

DNA / RNA extraction

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2022
Study completion: 2022
First posted: Jun 24, 2014
Registry last updated: Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed