Assisted Reproductive TechnologyNCT02171884
Study of the Impact of Freezing-thawing Procedures and the Prolonged Culture of Embryos on Epigenetic Regulation in Humans
An observational study of Assisted Reproductive Technology and Freezing/Thawing Procedure, run by Centre Hospitalier Universitaire Dijon at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Assisted Reproductive Technology, Freezing/Thawing Procedure, Prolonged Culture Procedure
- What is being tested?
- Sample of cord blood and Sample of placenta
- How many people
- 298 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Jan 2013to 2 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 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)
Who may be able to join
- 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
Who cannot join
- ---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 locations and contacts
2 sites in 1 country.
About this study
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:
- from the umbilical cord.
- from the placenta.
- Being tested
- Sample of cord blood, Sample of placenta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample of cord bloodOther
Sample of placentaOther
| Study group | Role | What they receive |
|---|---|---|
| Group E1 | Singletons born following ART via IVF/ICSI (short culture) Receives: Other: Sample of cord blood; Other: Sample of placenta | |
| Group EC1 | Singletons born following ART via IVF/ICSI and freezing-thawing of the embryo Receives: Other: Sample of cord blood; Other: Sample of placenta | |
| Group T1 | Singletons conceived naturally Receives: Other: Sample of cord blood; Other: Sample of placenta | |
| Group E2 | Singletons born following ART with IVF/ICSI (prolonged culture) Receives: Other: Sample of cord blood; Other: Sample of placenta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the expression of several genes subjected to imprinting (H19, IGF2, IGF2R, MEST, PEG3, SNRPN, IGF2, KCNQ1, GRB10 and PLAGL1)
DNA / RNA extraction
Measured: Baselines
Analysis of the expression of 3 transposable elements (HERV-K, LINE-1 and ALU)
DNA / RNA extraction
Measured: Baselines
Level of methylation and the level of expression of Genomic Imprinting (GI) and Transposable Elements (TE)
DNA / RNA extraction
Measured: Baselines
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study start17 Jan 2013
- Primary completion2 May 2022
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assisted Reproductive TechnologyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171884
- Sponsor's protocol ID
- FAUQUE DB 2013
- Status last verified
- Mar 2024
- First submitted
- 18 Jun 2014
- Last updated
- 26 Mar 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Freezing-thawing Procedures and the Prolonged Culture of Embryos on Epigenetic Regulation in Humans
- ClinicalTrials.gov ID
- NCT02171884
- Acronym / sponsor ID
- FAUQUE DB 2013
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 17 Jan 2013 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- from the umbilical cord.
- from the placenta.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group E1 | – | Other: Sample of cord blood, Other: Sample of placentaSingletons born following ART via IVF/ICSI (short culture) |
| Group EC1 | – | Other: Sample of cord blood, Other: Sample of placentaSingletons born following ART via IVF/ICSI and freezing-thawing of the embryo |
| Group T1 | – | Other: Sample of cord blood, Other: Sample of placentaSingletons conceived naturally |
| Group E2 | – | Other: Sample of cord blood, Other: Sample of placentaSingletons born following ART with IVF/ICSI (prolonged culture) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- pulmonary, cardiac
- renal and metabolic diseases (including type 1 and 2 diabetes prior to the pregnancy)
- systemic inflammatory diseases
- hypertension
- neurological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sample of cord blood | Other | Group E1, Group E2, Group EC1, Group T1 |
| Sample of placenta | Other | Group E1, Group E2, Group EC1, Group T1 |
Primary outcome
Analysis of the expression of several genes subjected to imprinting (H19, IGF2, IGF2R, MEST, PEG3, SNRPN, IGF2, KCNQ1, GRB10 and PLAGL1)
Time frame: Baselines
DNA / RNA extraction
Analysis of the expression of 3 transposable elements (HERV-K, LINE-1 and ALU)
Time frame: Baselines
DNA / RNA extraction
Level of methylation and the level of expression of Genomic Imprinting (GI) and Transposable Elements (TE)
Time frame: Baselines
DNA / RNA extraction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Assisted Reproductive Technology and Freezing/Thawing Procedure, run by Centre Hospitalier Universitaire Dijon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the expression of several genes subjected to imprinting (H19, IGF2, IGF2R, MEST, PEG3, SNRPN, IGF2, KCNQ1, GRB10 and PLAGL1) (time frame: Baselines). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.