Validation of Donor Oocytes Semi-automated Vitrification

NCT06238570 | Recruiting

• 1 other identifier: AOI 2020 CHAPUT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Oocyte vitrification is an effective method of freezing which has been authorized in France since 2011. The arrival of this technique has led to real improvements in the survival rate of oocytes after warming compared to that observed after slow freezing, a method previously applied. Oocytes reheated after vitrification show excellent results in terms of vitality and recovery of cellular functionality. Indeed, the fertilization rates observed after using warmed and fertilized oocytes in Assisted Reproduction Technology (ART) by intracytoplasmic sperm injection (ICSI) are similar to those obtained with fresh oocytes. However, the manual vitrification techniques used until now involve a learning curve and a potential variability of the completion time depending on the operator and the number of oocytes to be vitrified. Oocyte vitrification is a key step to optimize the chances of pregnancy in ART after using these oocytes. However, manual vitrification requires a learning curve, is technician-dependent and requires significant technical time. A semi-automatic vitrification device (GAVI®, Merck), which recently appeared on the market, has demonstrated its effectiveness in terms of speed of production and reproducibility of vitrification of embryos obtained in ART. To our knowledge, no study has analyzed the effectiveness of semi-automatic vitrification (GAVI®, Merck) on survival and oocyte quality after warming. It would therefore be interesting to evaluate the effectiveness of this automaton on oocyte vitrification in the context of oocyte donation and to determine the impact of semi-automatic vitrification on oocytes compared to manual vitrification. The main objective of this study is to demonstrate the non-inferiority of vitrification semi-automated device (Gavi) of oocytes with regard to the oocyte survival rate, compared to the manual technique used in ART. The investigator will compare the effectiveness of semi-automated vitrification device with the manual technique, in terms of ART results by comparing the fertilization rates, the number and quality of embryos obtained as well as the implantation rates in oocyte recipient patients. This study will then allow clinical application of the most efficient protocol for oocyte vitrification in the context of oocyte donation. A cost/effectiveness study will be carried out.

Conditions

Egg Donor; Fertility; Assisted Reproductive Technology; Vitrification

Keywords

Fertility; Egg donor; Vitrification; Assisted Reproductive Technology

Outcome Measures

Primary Outcomes (1)

• Oocyte survival

  Oocyte survival after semi-automated vitrification by the GAVI® device compared to the manual technique (Vitrolife) with egg donation. A warmed oocyte that has survived can then be used in AMP by ICSI technique.

  two years after the inclusion

Secondary Outcomes (2)

• Effectiveness of ART with egg donation after oovcytes semi-automated vitrification

  two years after vitrification

• Study the costs and cost-effectiveness

  at the end of the study 24 months

Study Arms (2)

Manual vitrification (using Vitrolife system)

PLACEBO COMPARATOR

The vitrification of the oocytes will be carried out by an authorized technician according to the manual protocol validated and used routinely.

Device: Vitrolife system

Semi-automatic vitrification of oocytes using the GAVI® automaton (Merck)

ACTIVE COMPARATOR

The vitrification of the oocytes will be carried out using the GAVI® automaton

Device: Gavi, Merck® (automated vitrification instrument)

Interventions

Gavi, Merck® (automated vitrification instrument) DEVICE

This instrument recently appeared on the market and demonstrated a high effectiveness in terms of processing time and reproducibility for embryo vitrification. To date, no study has analyzed the efficiency of this automated vitrification instrument on oocyte vitrification. The oocytes will be stored in closed cassettes in liquid nitrogen

Semi-automatic vitrification of oocytes using the GAVI® automaton (Merck)

Vitrolife system DEVICE

The oocytes vitrification will be carried out by an authorized technician according to the manual protocol validated and used routinely.

Manual vitrification (using Vitrolife system)

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Egg donor
• Oocyte puncture for donation
• Good quality ovarian reserve (Antral follicle count evaluated by ultrasound: CFA ≥ 7)
• Negative serology status (HIV, hepatitis B and C, syphilis, CMV and HTLV)
• Absence of symptoms or COVID contact
• Absence of genetic contraindication to egg donation
• Woman able to give informed consent to participate in research
• Woman affiliated to a social security scheme

You may not qualify if:

• Decline to participate
• Pregnant and lactating woman
• Person under guardianship, curatorship, deprivation of liberty, protection of justice

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 2, 2024
• Study Start: January 23, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

FR (1)