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Optimization of Oocyte Warming Protocols

Optimization of Oocyte Warming Protocols: a Comparative Study of Standard, Rapid, and Ultra-rapid Techniques on Oocyte Survival Rate and Spindle Morphometry

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07105891
Acronym
OVOfast
Enrollment
399
Registered
2025-08-06
Start date
2025-09-16
Completion date
2025-10-30
Last updated
2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oocyte Cryopreservation

Keywords

oocytes, thawing, art, vitrification, warming, survival rates

Brief summary

This is a retrospective study with a sibling design comparing new oocyte thawing protocols (rapid and ultra-rapid) with the traditional method

Interventions

OTHERThawing protocol

Standard thwaing

OTHERthawing protocol

Fast thawing

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

sibling design

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* All oocytes cryopreserved using the slow freezing technique * Oocytes from patients older than 40 years

Design outcomes

Primary

MeasureTime frameDescription
Oocytes Survival rate2 hours post-warmingOocyte 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.

Secondary

MeasureTime frameDescription
Spindle configuration2 hours post thawingSpindle configuration in thawed oocytes will be assessed using confocal microscopy following immunofluorescence staining. The spindles will be classified as normal, slightly aberrant, or aberrant.
Chromosome distribution2 hours post thawingChromosome distribution will be assessed using confocal microscopy following immunofluorescence staining. The distribution will be classified as normal, misaligned, or displaced.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026