DaVitri: Semi-Automated Vitrificacion Clinical Study

Overture Life

Status: Enrolling

Conditions: Fertility Issues

Treatments: Device: Automated Vitrification; Device: Manual Vitrification

Study type: Interventional

Funder types: Industry

Identifiers

NCT05607771

CIP-DV-000-GEN-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 72 estimated patients

Sex: Female

Ages: 30 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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72 participants in 2 patient groups

Manual

Experimental group

Description:

Oocytes will be prepared for vitrification using the manual protocol

Treatment:

Device: Manual Vitrification

Automated

Experimental group

Description:

Oocytes will be prepared for vitrification using Davitri device

Treatment:

Device: Automated Vitrification