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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05216068
Enrollment
57
Registered
2022-01-31
Start date
2021-12-01
Completion date
2024-11-30
Last updated
2025-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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. 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.

Interventions

DIAGNOSTIC_TESTNGS

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

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 50 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Blastocyst aneuploidy rate28 daysanormal Karyotype according to human genome 19 or updated version

Secondary

MeasureTime frameDescription
Whole genome amplification rate7 dayssuccess rate

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026