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

Chang Gung Medical Foundation

Status: Completed

Conditions: Chromosome Translocation; Recurrent Miscarriage; Genetic Disorders in Pregnancy

Treatments: Diagnostic Test: NGS

Study type: Interventional

Funder types: Other

Identifiers

NCT05216068

CMRPG8M0241

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: Female

Ages: 20 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 1 patient group

donated abandonment embryos

Other group

Description:

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

Treatment:

Diagnostic Test: NGS