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

NCT ID: NCT03478592

Last Updated: 2021-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 423 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-19
• Study Completion Date: 2021-02-03

Brief Summary

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.

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.

Conditions

Fertility Disorders

Keywords

Slow-freezing; Vitrification; Automated system; Embryos; Implantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

reference technique

Intervention Type: OTHER

Slow-freezing procedure is the reference technique, actually use at the Toulouse hospital, to cryopreserve embryos. Embryon are frozen with a slow freezing.

vitrification technique

In vitrification technique arm, embryon will be frozen with automated vitrification system

Group Type: EXPERIMENTAL

vitrification technique

Intervention Type: OTHER

Vitrification is the new technique to freeze embryons. In this study, the GAVI system will be use for for embryos automatically vitrification

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roger Léandri, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Hospital university of Toulouse

Toulouse, , France

Countries

France

Other Identifiers

RC31/16/8766

Identifier Type: -

Identifier Source: org_study_id