Interest of Automated Oocyte Freezing (Instruvit)

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.

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 Overview

• Status: Unknown
• Conditions: Automatic Vitrification; Manual Vitrification
• Intervention / Treatment: Other: Manual vitrification; Other: Vitrification with GaviTM system

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie BARBERET; Phone Number: 0380295101; Email: julie.barberet@chu-dijon.fr

Study Locations

• France
  • Dijon, France, 21079
    • Recruiting
    • CHU Dijon Bourgogne
    • Contact: Julie BARBERET; Phone Number: 0380295101; Email: julie.barberet@chu-dijon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Manual vitrification	Other: 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.
EXPERIMENTAL: Automatic vitrification	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
absence of post-thaw oocyte lysis	At warming
absence of post-thaw oocyte lysis	3 hours after warming

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ANTICIPATED): August 1, 2020
• Study Completion (ANTICIPATED): August 1, 2020

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: June 15, 2018
• First Posted (ACTUAL): June 26, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 26, 2018
• Last Update Submitted That Met QC Criteria: June 15, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Barberet AOI 2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No