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

NCT ID: NCT05216068

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2024-11-30

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.

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.

Conditions

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Chromosome Translocation Genetic Disorders in Pregnancy Recurrent Miscarriage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

NGS

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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NGS

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

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CMRPG8M0241

Identifier Type: -

Identifier Source: org_study_id

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