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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fertility Disorders

Intervention / Treatment
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* Other: reference technique
* Other: vitrification technique


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: reference technique slow freezing<br>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<br>* Slow-freezing procedure is the reference technique, actually use at the Toulouse hospital, to cryopreserve embryos. Embryon are frozen with a slow freezing.<br>|
| Experimental: vitrification technique<br>In vitrification technique arm, embryon will be frozen with automated vitrification system | Other: vitrification technique<br>* Vitrification is the new technique to freeze embryons. In this study, the GAVI system will be use for for embryos automatically vitrification<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Embryos, Implantation, Slow-freezing, Vitrification, Automated system