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Completed

NCT Number: NCT05216068

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

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.

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Key information

Conditions

Chromosome Translocation Abortion, Habitual Abortion, Spontaneous Chromosome Aberrations Female Urogenital Diseases and Pregnancy Complications Genetic Disorders in Pregnancy Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Recurrent Miscarriage Translocation, Genetic Urogenital Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Kaohsiung City, 123, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NGS

Diagnostic Test

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

Primary outcomes

  1. Blastocyst aneuploidy rate

    Time frame: 28 days

    anormal Karyotype according to human genome 19 or updated version

Secondary outcomes

  1. Whole genome amplification rate

    Time frame: 7 days

    success rate

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 31, 2022
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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