DaVitri: Semi-Automated Vitrificacion Clinical Study

Fertility Issues Clinical Trial

— DaVitri  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05607771
• Other study ID #: CIP-DV-000-GEN-001
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: July 2023
• Source: Overture Life
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility Issues
• Infertility

Intervention

Device:
• Manual Vitrification
Oocytes will be prepared for vitrification using the manual protocol
• Automated Vitrification
Oocytes will be prepared for vitrification using the DaVitri device

Locations

Country	Name	City	State
Argentina	Halitus Instituto Médico	Buenos Aires
Argentina	WeFIV Buenos Aires	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Overture Life

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thaw survival rates of oocytes	Number of valid oocytes/numbers of randomized oocytes	Day 1
Secondary	Blastocyst formation rate	Number of blastocysts at day 5 or 6/number of fertilized oocytes	Day 5