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Interest of Automated Oocyte Freezing

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03570073
Acronym
Instruvit
Enrollment
45
Registered
2018-06-26
Start date
2018-01-01
Completion date
2020-08-31
Last updated
2018-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Automatic Vitrification, Manual Vitrification

Brief 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 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.

Interventions

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.

OTHERVitrification 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.

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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.

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frame
absence of post-thaw oocyte lysisAt warming

Countries

France

Contacts

Primary ContactJulie BARBERET
julie.barberet@chu-dijon.fr0380295101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026