Direct Thawing of Vitrified Human Blastocyst

March 19, 2024 updated by: Yiu Leung David Chan, Chinese University of Hong Kong

A Pilot Study on Developing a One-step Direct Thawing Method on Human Blastocysts With Transcriptomic and Methylomic Comparison to Conventional Vitrified-thawing Method

There are more than million frozen embryo transfers around the world each year; a faster, safer, and cheaper method can save a significant amount of money for patients undergoing IVF treatment worldwide.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 000000
        • David Yiu Leung Chan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients who are willing to use direct-thawed blastocysts

Exclusion Criteria:

  • Patients who are not willing to use direct-thawed blastocysts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: direct thawing
Procedure: direct thawing
Vitrified blastocysts will be thawed directly into 1ml G-TL medium
Active Comparator: commercially available vitrification thawing
Procedure: Vitrification
Vitrified blastocysts will be thawed using commercially available one-step media.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blastocysts survival rate
Time Frame: up to 6 months
The overall survival rate for thawed blastocysts using different thawing method will be compared.
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ferilization rate
Time Frame: up to 12 months
The fertilization rate of frozen embryos using different thawing methods will be compared.
up to 12 months
pregnancy rate
Time Frame: up to 12 months
The pregnancy rate of patients who will be scheduled for the transfer of frozen embryos using different thawing methods will be compared.
up to 12 months
live birth rate
Time Frame: up to 24 months
The live birth rate of patients who will be scheduled for the transfer of frozen embryos using different thawing methods will be compared.
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2010.432

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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