NCT07105891

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
399

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 16, 2025

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

October 3, 2025

Status Verified

October 1, 2025

Enrollment Period

29 days

First QC Date

June 19, 2025

Last Update Submit

October 2, 2025

Conditions

Oocyte Cryopreservation

Keywords

oocytesthawingartvitrificationwarmingsurvival rates

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 hours post-warming

Secondary Outcomes (2)

  • Spindle configuration

    2 hours post thawing

  • Chromosome distribution

    2 hours post thawing

Study Arms (3)

Standard

OTHER

Standard thawing

Other: Thawing protocol

Fast

OTHER

Fast thawing

Other: thawing protocol

Ultrafast

OTHER

Ultrafast thawing

Other: thawing protocol

Interventions

thawing protocolOTHER

Standard thwaing

Standard

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele Hospital

Milan, Lombardy, 20132, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: sibling design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 19, 2025

First Posted

August 6, 2025

Study Start

September 16, 2025

Primary Completion

October 15, 2025

Study Completion

October 30, 2025

Last Updated

October 3, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)