Interest of Automated Oocyte Freezing (Instruvit)

University Hospital Center (CHU) Dijon Bourgogne

Status

Unknown

Conditions

Automatic Vitrification

Manual Vitrification

Treatments

Other: Vitrification with GaviTM system

Other: Manual vitrification

Study type

Interventional

Funder types

Other

Identifiers

NCT03570073

Barberet AOI 2017

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)