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

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05216068
Collaborator
(none)
200
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: NGS
 N/A

Detailed Description

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

  1. Collected 200 donate abandonment embryos: Five to six days after egg retrieval, well-developed embryos (called blastocysts).

  2. Blastocysts derived from patients seeking infertility treatment were generated.

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

  4. To standardize the operating procedures

  5. Paper writing.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Investigation and Diagnosis of the Chromosome Variation in Donated/Abandoned Blastocyst
Actual Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: donated abandonment embryos

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
Based on the next generation sequencing (NGS), WES can identify single nucleotide variants (SNVs) and small variants.

Outcome Measures

Primary Outcome Measures

  1. Blastocyst aneuploidy rate [28 days]

    anormal Karyotype according to human genome 19 or updated version

Secondary Outcome Measures

  1. Whole genome amplification rate [7 days]

    success rate

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chang Gung Memorial Hospital Kaohsiung Taiwan 123

Sponsors and Collaborators

  • Chang Gung Memorial Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT05216068
Other Study ID Numbers:
  • CMRPG8M0241
First Posted:
Jan 31, 2022
Last Update Posted:
Jan 31, 2022
Last Verified:
Jan 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chang Gung Memorial Hospital
pre-implantation genetic diagnosis
balanced reciprocal translocation (BRT)
structural variation (SV)
next generation sequencing
abandoned blastocysts
Additional relevant MeSH terms:
Abortion, Spontaneous
Abortion, Habitual
Genetic Diseases, Inborn
Translocation, Genetic

Study Results

No Results Posted as of Jan 31, 2022