Automatic VitrificationInstruvitNCT03570073
Interest of Automated Oocyte Freezing
A study testing Manual vitrification and Vitrification with GaviTM system in people with Automatic Vitrification and Manual Vitrification, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
In the space of a few decades, oocyte cryopreservation has become established in the world of reproductive biology with the authorization of oocyte vitrification. This ultra-fast manual freezing technique (authorised in France since 2011) is mainly used to preserve oocytes in women who have to undergo a treatment that… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Automatic Vitrification, Manual Vitrification
- What is being tested?
- Manual vitrification and Vitrification with GaviTM system
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to Aug 2020
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient must be:
- Adult
- Affiliated to a National Health System
- Informed about the study and having given consent
- Receiving an in vitro fertilization attempt with microinjection (ICSI, IntraCytoplasmic Sperm Injection) or having agreed to donate oocytes after approval by the Multidisciplinary Committee
- Having more than two immature, non-fertile oocytes on the day the oocytes are retrieved,
- Having at least two mature oocytes at the end of a 24-hour maturation in vitro.
Who cannot join
- Protected patient, under guardianship or trusteeship
- In Vitro Fertilization (IVF) Attempts
- Attempts at IVF or ICSI performed in the context of viral risk (both systems will be frozen in the same nitrogen tanks in the assisted reproduction laboratory)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon, 21079
Julie BARBERET, 0380295101, julie.barberet@chu-dijon.fr
About this study
Official title: Prospective Comparative Study of Two Manual and Automated Oocyte Vitrification Systems: Randomization of Mature Oocytes in Vitro of In Vitro Fertilization Attempts With Micro-injection at the "Centre d'Assistance Médicale à la Procréation" of the Dijon University Hospital
In the space of a few decades, oocyte cryopreservation has become established in the world of reproductive biology with the authorization of oocyte vitrification. This ultra-fast manual freezing technique (authorised in France since 2011) is mainly used to preserve oocytes in women who have to undergo a treatment that could potentially cause sterility. A clear improvement in survival rates since the early stages of slow freezing has been observed with vitrification but with fairly heterogeneous results Indeed, manual vitrification remains an operator-dependent technique with a long learning curve and which does not allow an oocyte survival rate of more than 70-80%.
The recent marketing of an automatic vitrification machine would make it possible to standardise the whole vitrification process from the contact/exchange of fluids to the sealing of the units, and thus potentially increase the oocyte survival rate. It seems to be in the best interest of women that their ability to conceive be preserved (probably for several years) with the technique that offers the best survival and reproducibility rates.
Read more
However, no studies have been conducted to assess the impact of such automation on oocyte survival.
For this reason the investigators wish to set up a comparative study between the routine, manual technique, and an automated technique (GAVI system), using immature oocytes, not suitable for fertilization, and usually discarded.
- Conditions
- Automatic Vitrification, Manual Vitrification
- Being tested
- Manual vitrification, Vitrification with GaviTM system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual vitrificationOther
Two oocytes will be frozen by vitrification. At thawing, the degree of rehydration objectified by the measurement of oocyte surfaces and the appearance of potential lysis will be studied thanks to culture in the embryoscope.
Vitrification with GaviTM systemOther
Two oocytes will be frozen by vitrification. At thawing, the degree of rehydration objectified by the measurement of oocyte surfaces and the appearance of potential lysis will be studied thanks to culture in the embryoscope.
| Study group | Role | What they receive |
|---|---|---|
| Manual vitrification | Active comparator | Not described Receives: Other: Manual vitrification |
| Automatic vitrification | Experimental | Not described Receives: Other: Vitrification with GaviTM system |
What is being measured
The primary outcome is the main question the study is designed to answer.
absence of post-thaw oocyte lysis
Measured: At warming
absence of post-thaw oocyte lysis
Measured: 3 hours after warming
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Jan 2018
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Automatic VitrificationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
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
- NCT03570073
- Sponsor's protocol ID
- Barberet AOI 2017
- Acronym
- Instruvit
- Status last verified
- Apr 2018
- First submitted
- 5 Jun 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barberet J, Ducreux B, Bruno C, Guilleman M, Simonot R, Lieury N, Guilloteau A, Bourc'his D, Fauque P. Comparison of oocyte vitrification using a semi-automated or a manual closed system in human siblings: survival and transcriptomic analyses. J Ovarian Res. 2022 Dec 5;15(1):128. doi: 10.1186/s13048-022-01064-3.
PubMed 36464714
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Study of Two Manual and Automated Oocyte Vitrification Systems: Randomization of Mature Oocytes in Vitro of In Vitro Fertilization Attempts With Micro-injection at the "Centre d'Assistance Médicale à la Procréation" of the Dijon University Hospital
- ClinicalTrials.gov ID
- NCT03570073
- Acronym / sponsor ID
- Instruvit / Barberet AOI 2017
- Conditions
- Automatic Vitrification, Manual Vitrification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 26 Jun 2018 (actual)
- 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.
In the space of a few decades, oocyte cryopreservation has become established in the world of reproductive biology with the authorization of oocyte vitrification. This ultra-fast manual freezing technique (authorised in France since 2011) is mainly used to preserve oocytes in women who have to undergo a treatment that could potentially cause sterility. A clear improvement in survival rates since the early stages of slow freezing has been observed with vitrification but with fairly heterogeneous results Indeed, manual vitrification remains an operator-dependent technique with a long learning curve and which does not allow an oocyte survival rate of more than 70-80%.
The recent marketing of an automatic vitrification machine would make it possible to standardise the whole vitrification process from the contact/exchange of fluids to the sealing of the units, and thus potentially increase the oocyte survival rate. It seems to be in the best interest of women that their ability to conceive be preserved (probably for several years) with the technique that offers the best survival and reproducibility rates.
However, no studies have been conducted to assess the impact of such automation on oocyte survival.
For this reason the investigators wish to set up a comparative study between the routine, manual technique, and an automated technique (GAVI system), using immature oocytes, not suitable for fertilization, and usually discarded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual vitrification | Active comparator | Other: Manual vitrification |
| Automatic vitrification | Experimental | Other: Vitrification with GaviTM system |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult
- Affiliated to a National Health System
- Informed about the study and having given consent
- Receiving an in vitro fertilization attempt with microinjection (ICSI, IntraCytoplasmic Sperm Injection) or having agreed to donate oocytes after approval by the Multidisciplinary Committee
- Having more than two immature, non-fertile oocytes on the day the oocytes are retrieved,
Key exclusion criteria (3 listed)
- Protected patient, under guardianship or trusteeship
- In Vitro Fertilization (IVF) Attempts
- Attempts at IVF or ICSI performed in the context of viral risk (both systems will be frozen in the same nitrogen tanks in the assisted reproduction laboratory)
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 |
|---|---|---|
| Manual vitrificationTwo oocytes will be frozen by vitrification. At thawing, the degree of rehydration objectified by the measurement of oocyte surfaces and the appearance of potential lysis will be studied thanks to culture in the embryoscope. | Other | Manual vitrification |
| Vitrification with GaviTM systemTwo oocytes will be frozen by vitrification. At thawing, the degree of rehydration objectified by the measurement of oocyte surfaces and the appearance of potential lysis will be studied thanks to culture in the embryoscope. | Other | Automatic vitrification |
Primary outcome
absence of post-thaw oocyte lysis
Time frame: At warming
absence of post-thaw oocyte lysis
Time frame: 3 hours after warming
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Derived from this study: PubMed 36464714Barberet J, Ducreux B, Bruno C, Guilleman M, Simonot R, Lieury N, Guilloteau A, Bourc'his D, Fauque P. Comparison of oocyte vitrification using a semi-automated or a manual closed system in human siblings: survival and transcriptomic analyses. J Ovarian Res. 2022 Dec 5;15(1):128. doi: 10.1186/s13048-022-01064-3.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual vitrification and Vitrification with GaviTM system in people with Automatic Vitrification and Manual Vitrification, run by Centre Hospitalier Universitaire Dijon at 1 site 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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julie BARBERET (0380295101, julie.barberet@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
absence of post-thaw oocyte lysis (time frame: At warming). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03570073, which also lists 1 linked publication.
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 Jun 2018.