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.

DaVitri: Semi-Automated Vitrificacion Clinical Study

Fertility Issues

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.

Manual Vitrification

Automated Vitrification

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

Number of valid oocytes/numbers of randomized oocytes

Number of blastocysts at day 5 or 6/number of fertilized oocytes

Oocytes will be prepared for vitrification using the manual protocol

Oocytes will be prepared for vitrification using Davitri device

DaVitri: Semi-Automated Vitrificacion Clinical Study

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status