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

University Hospital Center (CHU) Dijon Bourgogne

Status: Completed

Conditions: Assisted Reproductive Technology; Freezing/Thawing Procedure; Prolonged Culture Procedure

Treatments: Other: Sample of placenta; Other: Sample of cord blood

Study type: Observational

Funder types: Other

Identifiers

NCT02171884

FAUQUE DB 2013

Details and patient eligibility

About

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.

Enrollment: 298 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

298 participants in 4 patient groups

Group E1

Description:

Singletons born following ART via IVF/ICSI (short culture)

Treatment:

Other: Sample of placenta

Other: Sample of cord blood

Group EC1

Description:

Singletons born following ART via IVF/ICSI and freezing-thawing of the embryo

Treatment:

Other: Sample of placenta

Other: Sample of cord blood

Group T1

Description:

Singletons conceived naturally

Treatment:

Other: Sample of placenta

Other: Sample of cord blood

Group E2

Description:

Singletons born following ART with IVF/ICSI (prolonged culture)

Treatment:

Other: Sample of placenta

Other: Sample of cord blood