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OpenTrials
Active, Not Recruiting

NCT Number: NCT07105891

Optimization of Oocyte Warming Protocols

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Oocyte Cryopreservation

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS San Raffaele Hospital

Milan, Lombardy, 20132, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thawing protocol

Other

Standard thwaing

Primary outcomes

  1. 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.

Secondary outcomes

  1. Spindle configuration

    Time frame: 2 hours post thawing

    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.

  2. Chromosome distribution

    Time frame: 2 hours post thawing

    Chromosome distribution will be assessed using confocal microscopy following immunofluorescence staining. The distribution will be classified as normal, misaligned, or displaced.

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Acronym: OVOfast

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 6, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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