Study Results
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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UNKNOWN
NA
45 participants
INTERVENTIONAL
2018-01-01
2020-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Manual vitrification
Manual vitrification
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.
Automatic vitrification
Vitrification with GaviTM system
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.
Interventions
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Manual vitrification
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 system
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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)
18 Years
FEMALE
Yes
Sponsors
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Centre Hospitalier Universitaire Dijon
OTHER
Responsible Party
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Locations
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CHU Dijon Bourgogne
Dijon, , France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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Barberet AOI 2017
Identifier Type: -
Identifier Source: org_study_id
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