Direct Thawing of Vitrified Human Blastocyst | NCT06322823

Studies
Direct Thawing of Vitrified Human Blastocyst

NCT06322823

Sponsor

Chinese University of Hong Kong

Status

Completed

Last Update Posted

Mar 21, 2024Actual

Enrollment

116Actual

Phase

Not Applicable

Conditions

Interventions

direct thawing
Vitrification

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2023Actual

First Submitted Date

Mar 13, 2024

First Submission Date that Met QC Criteria

Mar 19, 2024

First Posted Date

Mar 21, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2024

Last Update Posted Date

Mar 21, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yiu Leung David Chan, Assistant Professor, Chinese University of Hong KongPrincipal Investigator

Lead Sponsor

Chinese University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

116Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
direct thawing	Experimental		Procedure: direct thawing
commercially available vitrification thawing	Active Comparator		Procedure: Vitrification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
direct thawing	Procedure	Vitrified blastocysts will be thawed directly into 1ml G-TL medium	direct thawing

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are willing to use direct-thawed blastocysts

Exclusion Criteria:

Patients who are not willing to use direct-thawed blastocysts

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
David Yiu Leung Chan		Hong Kong		000000	Hong Kong

Intervention Browse Module

MeSH Terms

ID	Term
D058989	Vitrification

Ancestor Terms

ID	Term
D044367	Phase Transition
D055585	Physical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided