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PGT-A Upgrade International Multicenter Observational Clinical Trial

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Summary

The NIH ClinicalTrials.gov registry has recorded a new international multicenter observational clinical trial (NCT07533630) evaluating PGT-A upgrade testing for preimplantation genetic testing in assisted reproductive technology. The study will enroll patients from seven domestic and international centers to assess embryo utilization rates and clinical outcomes including birth defects following PGT-A upgrade testing. Patient enrollment is expected to be completed within one year.

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What changed

NIH registered a new observational clinical trial to evaluate PGT-A upgrade testing capable of detecting embryonic chromosomal aneuploidy, mosaicism, microdeletions/microduplications, heteroploidy, and loss of heterozygosity in a single assay. The international multicenter study aims to reduce miscarriage and birth defects while improving embryo selection in infertility treatment.

Affected parties including healthcare providers specializing in assisted reproductive technology, clinical investigators, and patients undergoing PGT-A should note this trial as a potential participation opportunity. The study will provide molecular genetic evidence to inform clinical management of atypically fertilized embryos and optimize mosaic embryo transfer strategies.

Archived snapshot

Apr 17, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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

Observational NCT07533630 Kind: OBSERVATIONAL Apr 16, 2026

Abstract

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.

Conditions: Infertility Assisted Reproductive Technology

Interventions: PGT-A upgrade

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Last updated

Classification

Agency
NIH
Published
April 16th, 2026
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07533630
Docket
NCT07533630

Who this affects

Applies to
Healthcare providers Clinical investigators Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial Genetic testing Embryo analysis
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Medical Devices Pharmaceuticals

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