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

Not Applicable

Completed

• Conditions: Chromosome Translocation; Recurrent Miscarriage; Genetic Disorders in Pregnancy
• Interventions: Diagnostic Test: NGS

• Registration Number: NCT05216068
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2021-12-01
• Study First Submitted: 2022-01-23
• Study First Submitted QC: 2022-01-26
• Study First Posted: 2022-01-31
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Blastocyst aneuploidy rate	28 days	anormal Karyotype according to human genome 19 or updated version

Secondary Outcome Measures

Name	Time	Method
Whole genome amplification rate	7 days	success rate

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan