Study of the Impact of Freezing-thawing Procedures and the Prolonged Culture of Embryos on Epigenetic Regulation in Humans
1 other identifier
observational
298
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2013
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 17, 2013
CompletedFirst Submitted
Initial submission to the registry
June 18, 2014
CompletedFirst Posted
Study publicly available on registry
June 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2022
CompletedMarch 26, 2024
March 1, 2024
9.3 years
June 18, 2014
March 25, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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
Analysis of the expression of 3 transposable elements (HERV-K, LINE-1 and ALU)
DNA / RNA extraction
Baselines
Level of methylation and the level of expression of Genomic Imprinting (GI) and Transposable Elements (TE)
DNA / RNA extraction
Baselines
Study Arms (4)
Group E1
Singletons born following ART via IVF/ICSI (short culture)
Group EC1
Singletons born following ART via IVF/ICSI and freezing-thawing of the embryo
Group T1
Singletons conceived naturally
Group E2
Singletons born following ART with IVF/ICSI (prolonged culture)
Interventions
Eligibility Criteria
4 groups of infants: * conceived naturally * born following ART with IVF/ICSI (short culture) * born following ART with IVF/ICSI and freezing/thawing of the embryo * born following ART with IVF/ICSI (prolonged culture)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU de BESANCON
Besançon, 25030, France
CHU de DIJON
Dijon, 21079, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2014
First Posted
June 24, 2014
Study Start
January 17, 2013
Primary Completion
May 2, 2022
Study Completion
May 2, 2022
Last Updated
March 26, 2024
Record last verified: 2024-03