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

Assisted Reproductive Technology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02171884
• Other study ID #: FAUQUE DB 2013
• Status: Completed
• Start date: January 17, 2013
• Est. completion date: May 2, 2022

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: May 2, 2022
• Est. primary completion date: May 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Assisted Reproductive Technology
• Freezing/Thawing Procedure
• Prolonged Culture Procedure

Intervention

Other:
• Sample of cord blood

• Sample of placenta

Locations

Country	Name	City	State
France	CHU de BESANCON	Besancon
France	CHU de DIJON	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Analysis of the expression of 3 transposable elements (HERV-K, LINE-1 and ALU)	DNA / RNA extraction	Baselines
Primary	Level of methylation and the level of expression of Genomic Imprinting (GI) and Transposable Elements (TE)	DNA / RNA extraction	Baselines