NCT05607771

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

July 20, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

November 2, 2022

Last Update Submit

July 28, 2023

Conditions

Fertility Issues

Keywords

Vitrification

Outcome Measures

Primary Outcomes (1)

  • Thaw survival rates of oocytes

    Number of valid oocytes/numbers of randomized oocytes

    Day 1

Secondary Outcomes (1)

  • Blastocyst formation rate

    Day 5

Study Arms (2)

Manual

EXPERIMENTAL

Oocytes will be prepared for vitrification using the manual protocol

Device: Manual Vitrification

Automated

EXPERIMENTAL

Oocytes will be prepared for vitrification using Davitri device

Device: Automated Vitrification

Interventions

Manual VitrificationDEVICE

Oocytes will be prepared for vitrification using the manual protocol

Manual
Automated VitrificationDEVICE

Oocytes will be prepared for vitrification using the DaVitri device

Automated

Eligibility Criteria

Age30 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

WeFIV Buenos Aires

Buenos Aires, C1428ARP, Argentina

RECRUITING

Halitus Instituto Médico

Buenos Aires, Argentina

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Fernando Neuspiller, MD

    WeFiv

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2022

First Posted

November 7, 2022

Study Start

July 20, 2023

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

AR(2)