Assessment of the New Automated Vitrification System "GAVI" for Early Cleaved Embryos Cryopreservation (GAVI)

The meta-analysis comparing the cryopreservation of human embryos by vitrification or slow-freezing suggested that more well design studies as randomized trials are necessary to identify the most successful method for cryopreservation. The efficacy of the vitrification with the GAVI system will be compared with the conventional slow freezing method through a randomized control trial. Couples in IVF attempt will be randomized at the day of embryo cryopreservation by the biologist. Supernumerary frozen embryos will be thawed and transferred in utero in case of failure of the "fresh" embryo transfer. The outcomes of the thawing and frozen/thawed embryo transfer will be assessed. In the two groups, the patients will benefit of the standard IVF procedures applied in the Assisted Reproductive Technologies (ART) center of Toulouse.

Study Overview

• Status: Completed
• Conditions: Fertility Disorders
• Intervention / Treatment: Other: reference technique; Other: vitrification technique

Detailed Description

The last decade has seen a development of a new cryopreservation technique called vitrification. Despite a lack of randomized control trials comparing slow-freezing and vitrification, vitrification seems to show better recovery rates and pregnancy outcomes. However vitrification is a manual, labour-intensive and highly skilled procedure, results can vary between embryologists and clinics. The GAVI system, an automation instrument with a novel closed system device has been developed. The present study would like to assess the outcomes for embryos automatically vitrification processed with the GAVI system compared with those processed with conventional reference technique of slow freezing.

The meta-analysis comparing the cryopreservation of human embryos by vitrification or slow-freezing suggested that more well design studies as randomized trials are necessary to identify the most successful method for cryopreservation. The efficacy of the vitrification with the GAVI system will be compared with the conventional slow freezing method through a randomized control trial. Couples in IVF attempt will be randomized at the day of embryo cryopreservation by the biologist. Supernumerary frozen embryos will be thawed and transferred in utero in case of failure of the "fresh" embryo transfer. The outcomes of the thawing and frozen/thawed embryo transfer will be assessed. In the two groups, the patients will benefit of the standard IVF procedures applied in the Assisted Reproductive Technologies center of Toulouse.

• Study Type: Interventional
• Enrollment (Actual): 423
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Hospital University of Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Couple whose age is > 18 years and who are included in a IVF procedure with the possibility to cryopreserve embryos according to criteria applied at the hospital of Toulouse
• Signed informed consent by both partners in a couple
• Affiliation to a social security scheme for both partners of the couple

Exclusion Criteria:

• Couples who does not meet current requirements described by the bioethics law for accession to the ART procedure
• Positive plasma viral load for HIV, hepatitis C virus or hepatitis B virus during the year before the inclusion in one of the couple.
• One of the two partners (or both) is (are) in safeguarding justice, under guardianship or trusteeship.
• Couple included in another interventional study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: reference technique slow freezing; In reference technique slow freezing arm, embryon will be frozen with the conventional slow freezing procedure with the Freezal device apply a slow decreasing in temperature with moderate cryoprotector concentration	Other: reference technique; Slow-freezing procedure is the reference technique, actually use at the Toulouse hospital, to cryopreserve embryos. Embryon are frozen with a slow freezing.
Experimental: vitrification technique; In vitrification technique arm, embryon will be frozen with automated vitrification system	Other: vitrification technique; Vitrification is the new technique to freeze embryons. In this study, the GAVI system will be use for for embryos automatically vitrification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implantation rate of frozen/thawed embryos	The number of implantation embryo with cardiac activity in reference technique and in vitrification technic	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of intact blastomeres after thawing	It will be measured by microscopic evaluation by a biologist or an IVF laboratory technician at the time of thawing, routine very simple laboratory to do because at this early embryonic stage there are few cells: 4 to 8 cells and they are well individualized.	1 month
Implantation rate of transferred embryos.	number of implantation of transferred embryos in both technique	1 month
Live birth rates	Number of live birth for reference technique and for vitrification technique	9 months after the implantation

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Roger Léandri, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2018
• Primary Completion (Actual): February 3, 2021
• Study Completion (Actual): February 3, 2021

Study Registration Dates

• First Submitted: March 15, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (Actual): March 27, 2018

Study Record Updates

• Last Update Posted (Actual): October 28, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Vitrification; Implantation; Embryos; Slow-freezing; Automated system
• Other Study ID Numbers: RC31/16/8766

Drug and device information, study documents

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