Clinical Trial

Prospective International Multi-center Clinical Trial of PGT-A Upgrade

Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07533630
Lead Sponsor Reproductive & Genetic Hospital of CITIC-Xiangya
Collaborators: The First People's Hospital of Yunnan, Nanjing Women and Children's Healthcare Hospital, Biocódices, Miracle, Institute Bernabéu, Thomson Hospital
Conditions Infertility Assisted Reproductive Technology
Enrollment 1,700 participants
Start Date 2026-05
Primary Completion 2027-06 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2026-04-16