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Prospective International Multi-center Clinical Trial of PGT-A Upgrade
Sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
Summary
The goals of this international multicenter cross-sectional study are: 1. To provide patients with a comprehensive PGT solution capable of simultaneously detecting embryonic chromosomal aneuploidy, mosaicism, microdeletions/ microduplications, heteroploidy, and heterozygosity (LOH) in a single assay, thereby reducing miscarriage and birth defects; 2. To perform PGT analysis on abnormally fertilized embryos, select euploid embryos with normal ploidy, and calculate embryo utilization rates; 3. To reduce the false-positive rate through confirmation of mosaic embryos and subsequent analysis of its origin, thereby minimizing embryo wastage; 4. To provide molecular genetic evidence for expert consensus on clinical management of atypically fertilized embryos, of pathogenic/likely pathogenic small CNVs, optimize mosaic embryo transfer strategies, and inform preconception intervention; 5. To enhance international PGT testing standards through international multi-center collaboration. The study will enroll patients undergoing PGT-A from seven domestic and international centers, with patient enrollment expected to be completed within one year. PGT-A upgrade testing will be performed on embryos from enrolled patients, and the incidence rates of Incidence of microdeletions/microduplications, heteroploidy, LOH will be statistically analyzed. All patients who undergo embryo transfer will be followed up for clinical outcomes and birth defects.
Official title: Efficacy of PGT-A Upgrade in Preimplantation Genetic Testing of Embryos: An International Multicenter Prospective Clinical Study
Key Details
Gender
FEMALE
Age Range
20 Years - 46 Years
Study Type
OBSERVATIONAL
Enrollment
1700
Start Date
2026-05
Completion Date
2028-08
Last Updated
2026-04-16
Healthy Volunteers
No
Interventions
PGT-A upgrade
A comprehensive PGT solution capable of simultaneously detecting embryonic chromosomal aneuploidy, mosaicism, microdeletions/ microduplications, heteroploidy, and LOH in a single assay.
Locations (7)
Biocódices
Buenos Aires, Argentina
CITIC-Xiangya Reproductive & Genetic Hospital
Changsha, Hunan, China
Nanjing Women and Children's Healthcare Hospital
Nanjing, Jiangsu, China
First People's Hospital of Yunnan Province
Kunming, Yunnan, China
Thomson Hospital
Petaling Jaya, Malaysia
Miracle
Daegu, South Korea
Institute Bernabéu
Alicante, Spain