DaVitri: Semi-Automated Vitrificacion Clinical Study

Last updated: July 28, 2023
Sponsor: Overture Life
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Treatment

Automated Vitrification

Manual Vitrification

Clinical Study ID

NCT05607771
CIP-DV-000-GEN-001
  • Ages 30-45
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Donors will be selected according to the clinic's usual inclusion criteria in terms ofinfectious diseases, genetic diseases, karyotype, etc.

Exclusion

Exclusion Criteria:

  • BMI<18.5 or BMI >25
  • Implantation failure
  • Abnormal ovulation cycle
  • Endometrial thickness > 7mm

Study Design

Total Participants: 72
Treatment Group(s): 2
Primary Treatment: Automated Vitrification
Phase:
Study Start date:
July 20, 2023
Estimated Completion Date:
July 30, 2024

Study 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.

Connect with a study center

  • Halitus Instituto Médico

    Buenos Aires,
    Argentina

    Site Not Available

  • WeFIV Buenos Aires

    Buenos Aires, C1428ARP
    Argentina

    Active - Recruiting

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