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NCT05216068 Clinical Trial

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

Recurrent Miscarriage Clinical Trial

Official title:
Investigation and Diagnosis of the Chromosome Variation in Donated/Abandoned Blastocyst

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05216068
Other study ID # CMRPG8M0241
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date December 31, 2024

Study information
Verified date February 2024
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 31, 2024
Est. primary completion date November 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 50 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Taiwan Chang Gung Memorial Hospital Kaohsiung

Sponsors (1)
Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Blastocyst aneuploidy rate anormal Karyotype according to human genome 19 or updated version 28 days
Secondary Whole genome amplification rate success rate 7 days
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