DaVitri: Semi-Automated Vitrificacion Clinical Study

Study Overview
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Brief Summary
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The main objective of this clinical study is to demonstrate the non-inferiority of the semi automated device (DaVitri) developed by Overture Life in the preparation procedures for vitrification of human samples.

Detailed Description
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Vitrification is a manual technique that is routinely used in assisted reproduction clinics for the cryopreservation of oocytes and embryos in liquid nitrogen at -196oC. There are different methods of vitrification, the most used being the Cryotop of Kitazato. This is a manual process that requires precision and experience to achieve a good result. For this reason, the correct execution of the technique is considered key in in vitro fertilization (IVF) treatments, as it can favor the preservation of fertility and optimize clinical results. The purpose of the study is to validate the viability of the semi automated vitrification process, to obtain survival rates similar to or superior to manual processes, and also the capacity to provide greater reproducibility in the results. The semi automatic exchange of vitrification fluids in human oocytes is as efficient as the manual procedure, in terms of survival (85-90%), but with significantly lower variability between technicians and between centers (95% reproducibility), as well as reduced manual processing times. The initial hypothesis is that semi automated vitrification equals or improves the manual technique, thus introducing a new standardized protocol for clinical use.

Official Title
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Paired Non-inferiority Study Comparing Overture Semi-Automated Vitrification System (DaVitri) to Standard Manual Process

Conditions
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Fertility Issues

Intervention / Treatment
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* Device: Manual Vitrification
* Device: Automated Vitrification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Donors will be selected according to the clinic's usual inclusion criteria in terms of infectious diseases, genetic diseases, karyotype, etc. Exclusion Criteria: BMI<18.5 or BMI >25 Implantation failure Abnormal ovulation cycle Endometrial thickness > 7mm

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual<br>Oocytes will be prepared for vitrification using the manual protocol | Device: Manual Vitrification<br>* Oocytes will be prepared for vitrification using the manual protocol<br>|
| Experimental: Automated<br>Oocytes will be prepared for vitrification using Davitri device | Device: Automated Vitrification<br>* Oocytes will be prepared for vitrification using the DaVitri device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thaw survival rates of oocytes | Number of valid oocytes/numbers of randomized oocytes | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blastocyst formation rate | Number of blastocysts at day 5 or 6/number of fertilized oocytes | Day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitrification