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Investigation and Diagnosis of the Chromosome Variation in Donated/Abandoned Blastocyst

Primary Purpose

Chromosome Translocation, Genetic Disorders in Pregnancy, Recurrent Miscarriage

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
NGS
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chromosome Translocation focused on measuring pre-implantation genetic diagnosis, balanced reciprocal translocation (BRT), structural variation (SV), next generation sequencing, abandoned blastocysts

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

donated abandonment embryos

Arm Description

Embryos biopsies for PGT-A (by use of NGS platforms from our institute) will be used for the validation of our Lab QC.

Outcomes

Primary Outcome Measures

Blastocyst aneuploidy rate
anormal Karyotype according to human genome 19 or updated version

Secondary Outcome Measures

Whole genome amplification rate
success rate

Full Information

First Posted
January 23, 2022
Last Updated
September 5, 2023
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05216068
Brief Title
Investigation and Diagnosis of the Chromosome Variation in Donated/Abandoned Blastocyst
Official Title
Investigation and Diagnosis of the Chromosome Variation in Donated/Abandoned Blastocyst
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chromosome Translocation, Genetic Disorders in Pregnancy, Recurrent Miscarriage
Keywords
pre-implantation genetic diagnosis, balanced reciprocal translocation (BRT), structural variation (SV), next generation sequencing, abandoned blastocysts

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
donated abandonment embryos
Arm Type
Other
Arm Description
Embryos biopsies for PGT-A (by use of NGS platforms from our institute) will be used for the validation of our Lab QC.
Intervention Type
Diagnostic Test
Intervention Name(s)
NGS
Intervention Description
Based on the next generation sequencing (NGS), WES can identify single nucleotide variants (SNVs) and small variants.
Primary Outcome Measure Information:
Title
Blastocyst aneuploidy rate
Description
anormal Karyotype according to human genome 19 or updated version
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Whole genome amplification rate
Description
success rate
Time Frame
7 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
123
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuo-Chung Lan, PhD
Phone
+886-975056415
Email
lankuochung@gmail.com
First Name & Middle Initial & Last Name & Degree
Ni-Chin Tsai, MD
Phone
+886-975369271
Email
ninytsai@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Investigation and Diagnosis of the Chromosome Variation in Donated/Abandoned Blastocyst

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