Investigation and Diagnosis of the Chromosome Variation i... | NCT05216068

Studies
Investigation and Diagnosis of the Chromosome Variation in Donated/abandoned Blastocyst

NCT05216068

Sponsor

Chang Gung Memorial Hospital

Status

Completed

Last Update Posted

Feb 20, 2025Actual

Enrollment

57Actual

Phase

Not Applicable

Conditions

Chromosome Translocation
Genetic Disorders in Pregnancy
Recurrent Miscarriage

Interventions

Countries

Taiwan

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

Feb 2025

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

Dec 1, 2021Actual

Primary Completion Date

Nov 30, 2024Actual

Completion Date

Nov 30, 2024Actual

First Submitted Date

Jan 23, 2022

First Submission Date that Met QC Criteria

Jan 26, 2022

First Posted Date

Jan 31, 2022Actual

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

Feb 19, 2025

Last Update Posted Date

Feb 20, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Blastocysts derived from patients seeking infertility treatment were generated by in vitro fertilization and embryo culture as previously described, and were evaluated using the Gardner system. As part of the embryo selection process, cells of TE biopsy were collected, and blastocysts were vitrified. The clinical TE biopsies were subjected to whole genome amplification (WGA) with SurePlex reagents (Illumina) followed by NGS-based PGT-A using Illumina's VeriSeq kit (Illumina) on a MiSeq system (Illumina) according to the manufacturer's protocol.

Detailed Description

Collected 200 donate abandonment embryos (well-developed blastocysts) for research under the National Assisted Reproduction Act of Taiwan.

Collected 200 donate abandonment embryos: Five to six days after egg retrieval, well-developed embryos (called blastocysts).
Blastocysts derived from patients seeking infertility treatment were generated.
Embryos biopsies for PGT-A (by use of NGS platforms from our institute) will be used for the validation of our Lab QC embryo.
To standardize the operating procedures
Paper writing.

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

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
donated abandonment embryos	Other	Embryos biopsies for PGT-A (by use of NGS platforms from our institute) will be used for the validation of our Lab QC.	Diagnostic Test: NGS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NGS	Diagnostic Test	Based on the next generation sequencing (NGS), WES can identify single nucleotide variants (SNVs) and small variants.	donated abandonment embryos

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blastocyst aneuploidy rate	anormal Karyotype according to human genome 19 or updated version	28 days

Secondary Outcomes

Measure	Description	Time Frame
Whole genome amplification rate	success rate	7 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

the surplus blastocysts
parents consent to donate the embryos

Exclusion Criteria:

not agree to participate in this program
whose embryo morphology and quality do not meet the technical requirements for genetic testing

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

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
Chang Gung Memorial Hospital		Kaohsiung City		123	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D014178	Translocation, Genetic
D000026	Abortion, Habitual

Ancestor Terms

ID	Term
D002869	Chromosome Aberrations
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D000022	Abortion, Spontaneous

Browse Leaves

Not provided

Browse Branches

Not provided