DaVitri: Semi-Automated Vitrificacion Clinical Study

NCT ID: NCT05607771

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-20

Study Completion Date

2024-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fertility Issues

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Manual

Oocytes will be prepared for vitrification using the manual protocol

Group Type EXPERIMENTAL

Manual Vitrification

Intervention Type DEVICE

Oocytes will be prepared for vitrification using the manual protocol

Automated

Oocytes will be prepared for vitrification using Davitri device

Group Type EXPERIMENTAL

Automated Vitrification

Intervention Type DEVICE

Oocytes will be prepared for vitrification using the DaVitri device

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Manual Vitrification

Oocytes will be prepared for vitrification using the manual protocol

Intervention Type DEVICE

Automated Vitrification

Oocytes will be prepared for vitrification using the DaVitri device

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* BMI\<18.5 or BMI \>25
* Implantation failure
* Abnormal ovulation cycle
* Endometrial thickness \> 7mm
Minimum Eligible Age

30 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Overture Life

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fernando Neuspiller, MD

Role: PRINCIPAL_INVESTIGATOR

WeFiv

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Halitus Instituto Médico

Buenos Aires, , Argentina

Site Status ACTIVE_NOT_RECRUITING

WeFIV Buenos Aires

Buenos Aires, , Argentina

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Argentina

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Fernando Neuspiller

Role: primary

0810-220-2200

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CIP-DV-000-GEN-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Closed Vitrification of Oocytes
NCT01745536 WITHDRAWN NA
Automated Sperm Selection
NCT05240469 RECRUITING NA