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
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Genetic Diseases, Inborn
• Genetic Disorders in Pregnancy
• Recurrent Miscarriage

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