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

February 19, 2025 updated by: Chang Gung Memorial Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 123
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Diagnostic test: NGS
Based on the next generation sequencing (NGS), WES can identify single nucleotide variants (SNVs) and small variants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blastocyst aneuploidy rate
Time Frame: 28 days
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
Time Frame: 7 days
success rate
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

January 23, 2022

First Submitted That Met QC Criteria

January 26, 2022

First Posted (Actual)

January 31, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMRPG8M0241

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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