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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chromosome Translocation, Genetic Disorders in Pregnancy, Recurrent Miscarriage

Intervention / Treatment
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* Diagnostic Test: NGS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: donated abandonment embryos<br>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<br>* Based on the next generation sequencing (NGS), WES can identify single nucleotide variants (SNVs) and small variants.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole genome amplification rate | success rate | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pre-implantation genetic diagnosis, balanced reciprocal translocation (BRT), structural variation (SV), next generation sequencing, abandoned blastocysts