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
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
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
NCT ID
NCT05216068
First Posted
January 23, 2022
Last Updated
September 5, 2023
Sponsor
Chang Gung Memorial Hospital
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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