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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual | Experimental | Oocytes will be prepared for vitrification using the manual protocol |
|
| Automated | Experimental | Oocytes will be prepared for vitrification using Davitri device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Vitrification | Device | Oocytes will be prepared for vitrification using the manual protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Thaw survival rates of oocytes | Number of valid oocytes/numbers of randomized oocytes | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Blastocyst formation rate | Number of blastocysts at day 5 or 6/number of fertilized oocytes | Day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Neuspiller, MD | WeFiv | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WeFIV Buenos Aires | Recruiting | Buenos Aires | C1428ARP | Argentina |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Automated Vitrification | Device | Oocytes will be prepared for vitrification using the DaVitri device |
|
| Halitus Instituto Médico | Active, not recruiting | Buenos Aires | Argentina |