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

Fertility Disorders Clinical Trial

— GAVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03478592
• Other study ID #: RC31/16/8766
• Status: Completed
• Phase: N/A
• Start date: January 19, 2018
• Est. completion date: February 3, 2021

Study information

• Verified date: October 2021
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 423
• Est. completion date: February 3, 2021
• Est. primary completion date: February 3, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fertility Disorders

Intervention

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

Locations

Country	Name	City	State
France	Hospital university of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implantation rate of frozen/thawed embryos	The number of implantation embryo with cardiac activity in reference technique and in vitrification technic	1 month
Secondary	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
Secondary	Implantation rate of transferred embryos.	number of implantation of transferred embryos in both technique	1 month
Secondary	Live birth rates	Number of live birth for reference technique and for vitrification technique	9 months after the implantation