Fertility IssuesDaVitriNCT05607771
DaVitri: Semi-Automated Vitrificacion Clinical Study
A study testing Manual Vitrification and Automated Vitrification in people with Fertility Issues, run by Overture Life at 2 sites in Argentina.
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. Read more about this study
- Who is it for?
- Ages 30 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Issues
- What is being tested?
- Manual Vitrification and Automated Vitrification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesArgentina
- Study dates
- 20 Jul 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Donors will be selected according to the clinic's usual inclusion criteria in terms of infectious diseases, genetic diseases, karyotype, etc.
Who cannot join
- BMI<18.5 or BMI >25
- Implantation failure
- Abnormal ovulation cycle
- Endometrial thickness > 7mm
Trial locations and contacts
2 sites in 1 country.
Argentina2 sites, 1 recruiting
- Recruiting
WeFIV Buenos Aires
Buenos Aires, C1428ARP
Fernando Neuspiller, 0810-220-2200, Fernando.Neuspiller@wefiv.com
- Active, not recruiting
Halitus Instituto Médico
Buenos Aires
About this study
Official title: 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.
Read the 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.
- Conditions
- Fertility Issues
- Being tested
- Manual Vitrification, Automated Vitrification
- Keywords
- Vitrification
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual VitrificationDevice
Oocytes will be prepared for vitrification using the manual protocol
Automated VitrificationDevice
Oocytes will be prepared for vitrification using the DaVitri device
| Study group | Role | What they receive |
|---|---|---|
| Manual | Experimental | Oocytes will be prepared for vitrification using the manual protocol Receives: Device: Manual Vitrification |
| Automated | Experimental | Oocytes will be prepared for vitrification using Davitri device Receives: Device: Automated Vitrification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thaw survival rates of oocytes
Number of valid oocytes/numbers of randomized oocytes
Measured: Day 1
Secondary outcomes (1)
Blastocyst formation rate
Number of blastocysts at day 5 or 6/number of fertilized oocytes
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start20 Jul 2023
- Primary completion30 Jul 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Overture Life
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fernando Neuspiller, MD, Principal investigator, WeFiv
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607771
- Sponsor's protocol ID
- CIP-DV-000-GEN-001
- Acronym
- DaVitri
- Status last verified
- Jul 2023
- First submitted
- 2 Nov 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paired Non-inferiority Study Comparing Overture Semi-Automated Vitrification System ("DaVitri") to Standard Manual Process
- ClinicalTrials.gov ID
- NCT05607771
- Acronym / sponsor ID
- DaVitri / CIP-DV-000-GEN-001
- Conditions
- Fertility Issues
- Keywords
- Vitrification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Overture LifeIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual | Experimental | Device: Manual VitrificationOocytes will be prepared for vitrification using the manual protocol |
| Automated | Experimental | Device: Automated VitrificationOocytes will be prepared for vitrification using Davitri device |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Donors will be selected according to the clinic's usual inclusion criteria in terms of infectious diseases, genetic diseases, karyotype, etc.
Key exclusion criteria (4 listed)
- BMI<18.5 or BMI >25
- Implantation failure
- Abnormal ovulation cycle
- Endometrial thickness > 7mm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual VitrificationOocytes will be prepared for vitrification using the manual protocol | Device | Manual |
| Automated VitrificationOocytes will be prepared for vitrification using the DaVitri device | Device | Automated |
Primary outcome
Thaw survival rates of oocytes
Time frame: Day 1
Number of valid oocytes/numbers of randomized oocytes
1 secondary outcome
Blastocyst formation rate
Time frame: Day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Neuspiller, MD principal investigator
WeFiv
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Vitrification and Automated Vitrification in people with Fertility Issues, run by Overture Life at 2 sites in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thaw survival rates of oocytes (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.