DaVitri: Semi-Automated Vitrificacion Clinical Study

Not Applicable

Recruiting

• Conditions: Fertility Issues
• Interventions: Device: Manual Vitrification; Device: Automated Vitrification

• Registration Number: NCT05607771
• Lead Sponsor: Overture Life

Brief 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.

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 Timeline

• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-07
• Status Verified: 2023-07
• Study Start: 2023-07-20
• Last Update Submitted: 2023-07-28
• Last Update Posted: 2023-08-01
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Manual	Manual Vitrification	Oocytes will be prepared for vitrification using the manual protocol
Automated	Automated Vitrification	Oocytes will be prepared for vitrification using Davitri device

Primary Outcome Measures

Name	Time	Method
Thaw survival rates of oocytes	Day 1	Number of valid oocytes/numbers of randomized oocytes

Secondary Outcome Measures

Name	Time	Method
Blastocyst formation rate	Day 5	Number of blastocysts at day 5 or 6/number of fertilized oocytes

Trial Locations

Locations (2)

WeFIV Buenos Aires; 🇦🇷 Buenos Aires, Argentina

Halitus Instituto Médico; 🇦🇷 Buenos Aires, Argentina