DaVitri: Semi-Automated Vitrificacion Clinical Study (DaVitri)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Fertility Issues
• Intervention / Treatment: Device: Manual Vitrification; Device: Automated Vitrification

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1428ARP
    • Recruiting
    • WeFIV Buenos Aires
    • Contact: Fernando Neuspiller; Phone Number: 0810-220-2200; Email: Fernando.Neuspiller@wefiv.com
  • Buenos Aires, Argentina
    • Active, not recruiting
    • Halitus Instituto Médico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual; Oocytes will be prepared for vitrification using the manual protocol	Device: Manual Vitrification; Oocytes will be prepared for vitrification using the manual protocol
Experimental: Automated; Oocytes will be prepared for vitrification using Davitri device	Device: Automated Vitrification; Oocytes will be prepared for vitrification using the DaVitri device

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Overture Life
• Investigators: Principal Investigator: Fernando Neuspiller, MD, WeFIV

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 7, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Vitrification
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: CIP-DV-000-GEN-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No