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NCT07533630

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

Sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya

View on ClinicalTrials.gov

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

OTHER

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