Optimization of Oocyte Warming Protocols

N/AActive Not RecruitingNCT07105891

IRCCS San Raffaele399 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

399

Conditions

Oocyte Cryopreservation

Interventions

Thawing protocolOTHER

Standard thwaing

thawing protocolOTHER

Fast thawing

thawing protocolOTHER

Ultrafast thawing

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

IRCCS San Raffaele Hospital

Milan, Lombardy, Italy

Outcomes

Primary Outcomes

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.

Time frame: 2 hours post-warming

Secondary Outcomes

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.

Time frame: 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.

Time frame: 2 hours post thawing

Data from ClinicalTrials.gov

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