Oocyte CryopreservationOVOfastNCT07105891
Optimization of Oocyte Warming Protocols
A study testing Thawing protocol in people with Oocyte Cryopreservation, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
This is a retrospective study with a sibling design comparing new oocyte thawing protocols (rapid and ultra-rapid) with the traditional method Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oocyte Cryopreservation
- What is being tested?
- Thawing protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 1 siteItaly
- Study dates
- 16 Sep 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Vitrified oocytes from the Centro Scienze della Natalità, IRCCS San Raffaele Hospital
- Patients who explicitly consented to the disposal of their stored gametes and authorized their use for research purposes through the informed consent process
- Oocytes cryopreserved using the vitrification technique
- Patients age 20-39 yo
Who cannot join
- All oocytes cryopreserved using the slow freezing technique
- Oocytes from patients older than 40 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of Oocyte Warming Protocols: a Comparative Study of Standard, Rapid, and Ultra-rapid Techniques on Oocyte Survival Rate and Spindle Morphometry
This is a retrospective study with a sibling design comparing new oocyte thawing protocols (rapid and ultra-rapid) with the traditional method
- Conditions
- Oocyte Cryopreservation
- Being tested
- Thawing protocol
- Keywords
- oocytes, thawing, art, vitrification, warming, survival rates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thawing protocolOther
Standard thwaing
thawing protocolOther
Fast thawing
thawing protocolOther
Ultrafast thawing
| Study group | Role | What they receive |
|---|---|---|
| Standard | Other | Standard thawing Receives: Other: Thawing protocol |
| Fast | Other | Fast thawing Receives: Other: thawing protocol |
| Ultrafast | Other | Ultrafast thawing Receives: Other: thawing protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oocytes Survival rate
Oocyte survival rate will be assessed 2 hours after thawing using morphological evaluation under a light microscope. Surviving oocytes will be identified by the presence of an intact zona pellucida and oolemma, a round shape, and homogeneous cytoplasm without signs of lysis, fragmentation, or cytoplasmic granulation.
Measured: 2 hours post-warming
Secondary outcomes (2)
Spindle configuration
Spindle configuration in thawed oocytes will be assessed using confocal microscopy following immunofluorescence staining. The spindles will be classified as normal, slightly aberrant, or aberrant.
Measured: 2 hours post thawing
Chromosome distribution
Chromosome distribution will be assessed using confocal microscopy following immunofluorescence staining. The distribution will be classified as normal, misaligned, or displaced.
Measured: 2 hours post thawing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start16 Sep 2025
- Primary completion15 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oocyte CryopreservationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- sibling design
- Masking
- None (open label)
- Enrolment
- 399 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Papaleo, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105891
- Sponsor's protocol ID
- OVOfast
- Acronym
- OVOfast
- Status last verified
- Oct 2025
- First submitted
- 19 Jun 2025
- Last updated
- 3 Oct 2025
- 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 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Oocyte Warming Protocols: a Comparative Study of Standard, Rapid, and Ultra-rapid Techniques on Oocyte Survival Rate and Spindle Morphometry
- ClinicalTrials.gov ID
- NCT07105891
- Acronym / sponsor ID
- OVOfast / OVOfast
- Conditions
- Oocyte Cryopreservation
- Keywords
- oocytes, thawing, art, vitrification, warming, survival rates
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 399 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 6 Aug 2025 (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.
This is a retrospective study with a sibling design comparing new oocyte thawing protocols (rapid and ultra-rapid) with the traditional method
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- sibling design
| Arm | Type | Receives |
|---|---|---|
| Standard | Other | Other: Thawing protocolStandard thawing |
| Fast | Other | Other: thawing protocolFast thawing |
| Ultrafast | Other | Other: thawing protocolUltrafast thawing |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Vitrified oocytes from the Centro Scienze della Natalità, IRCCS San Raffaele Hospital
- Patients who explicitly consented to the disposal of their stored gametes and authorized their use for research purposes through the informed consent process
- Oocytes cryopreserved using the vitrification technique
- Patients age 20-39 yo
Key exclusion criteria (2 listed)
- All oocytes cryopreserved using the slow freezing technique
- Oocytes from patients older than 40 years
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 |
|---|---|---|
| Thawing protocolStandard thwaing | Other | Standard |
| thawing protocolFast thawing | Other | Fast |
| thawing protocolUltrafast thawing | Other | Ultrafast |
Primary outcome
Oocytes Survival rate
Time frame: 2 hours post-warming
Oocyte survival rate will be assessed 2 hours after thawing using morphological evaluation under a light microscope. Surviving oocytes will be identified by the presence of an intact zona pellucida and oolemma, a round shape, and homogeneous cytoplasm without signs of lysis, fragmentation, or cytoplasmic granulation.
2 secondary outcomes
Spindle configuration
Time frame: 2 hours post thawing
Chromosome distribution
Time frame: 2 hours post thawing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thawing protocol in people with Oocyte Cryopreservation, run by IRCCS San Raffaele at 1 site in Italy.
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 4 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oocytes Survival rate (time frame: 2 hours post-warming). 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 3 Oct 2025.