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

NCT ID: NCT02171884

Last Updated: 2024-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

298 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-17

Study Completion Date

2022-05-02

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:

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

Detailed Description

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Conditions

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Assisted Reproductive Technology Freezing/Thawing Procedure Prolonged Culture Procedure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group E1

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

Sample of cord blood

Intervention Type OTHER

Sample of placenta

Intervention Type OTHER

Group EC1

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

Sample of cord blood

Intervention Type OTHER

Sample of placenta

Intervention Type OTHER

Group T1

Singletons conceived naturally

Sample of cord blood

Intervention Type OTHER

Sample of placenta

Intervention Type OTHER

Group E2

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

Sample of cord blood

Intervention Type OTHER

Sample of placenta

Intervention Type OTHER

Interventions

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Sample of cord blood

Intervention Type OTHER

Sample of placenta

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de BESANCON

Besançon, , France

Site Status

CHU de DIJON

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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FAUQUE DB 2013

Identifier Type: -

Identifier Source: org_study_id

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