Interest of Automated Oocyte Freezing

Not Applicable

• Conditions: Manual Vitrification; Automatic Vitrification
• Interventions: Other: Manual vitrification; Other: Vitrification with GaviTM system

• Registration Number: NCT03570073
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2018-04
• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-06-15
• Last Update Submitted: 2018-06-15
• Study First Posted: 2018-06-26
• Last Update Posted: 2018-06-26
• Primary Completion: 2020-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 45

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual vitrification	Manual vitrification	-
Automatic vitrification	Vitrification with GaviTM system	-

Primary Outcome Measures

Name	Time	Method
absence of post-thaw oocyte lysis	3 hours after warming

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France