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

• Sponsor: Centre Hospitalier Universitaire Dijon (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02171884
• Collaborator: (none)
• Enrollment: 366
• Locations: 2
• Anticipated Duration (Months): 145.4
• Patients Per Site: 183
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 366 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: Jan 17, 2013
• Anticipated Primary Completion Date: Mar 1, 2025
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

Arm	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

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) [Baselines]

   DNA / RNA extraction

2. Analysis of the expression of 3 transposable elements (HERV-K, LINE-1 and ALU) [Baselines]

   DNA / RNA extraction

3. Level of methylation and the level of expression of Genomic Imprinting (GI) and Transposable Elements (TE) [Baselines]

   DNA / RNA extraction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	CHU de BESANCON	Besancon		France	25030
2	CHU de DIJON	Dijon		France	21079

Sponsors and Collaborators

• Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire Dijon
• ClinicalTrials.gov Identifier: NCT02171884
• Other Study ID Numbers: FAUQUE DB 2013
• First Posted: Jun 24, 2014
• Last Update Posted: Jan 20, 2022
• Last Verified: Jan 1, 2022

Study Results

No Results Posted as of Jan 20, 2022