NCT04856696

Clinical Application of Non-invasive PGT-A

Clinical Application of Non-invasive Preimplantation Genetic Testing for Aneuploidies

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Kaohsiung Veterans General Hospital. · Academic / Other
• Sex: Female
• Age: 30 Years – 44 Years
• Healthy volunteers: Not accepted

Summary

The study aims to investigate the difference of in vitro fertilization (IVF) outcomes among non-invasive PGT-A, PGT-A and combined non-invasive PGT-A and PGT-A.

Detailed description

Background Chromosome abnormality is a leading cause of implantation failure and miscarriage. Chromosome abnormality increases with age, resulting in reduced pregnancy rate. Nowadays, preimplantation genetic testing for aneuploidies (PGT-A) could be used for detection of aneuploidy. However, PGT-A needs embryo biopsy which is invasive and may cause embryo damage. It was found that cell free DNA could be isolated from culture media. The cell free DNA from culture media also could be used to detect embryo ploidy, called non-invasive PGT-A. Objective The study aims to investigate the difference of in vitro fertilization (IVF) outcomes among non-invasive PGT-A, PGT-A and combined non-invasive PGT-A and PGT-A. Another aim of this study is to check the concordance rate between non-invasive PGT-A and PGT-A. Methods The prospective cohort study will be performed at the reproductive medical center of Kaohsiung Veterans General Hospital, in Kaohsiung, Taiwan. Participants who plan to receive an IVF cycle and preimplantation genetic testing for aneuploidies will be enrolled in this study. The investigators will divide the participants into 3 groups: (1) combined non-invasive PGT-A and PGT-A; (2) PGT-A; (3) non-invasive PGT-A. Basal characteristics, infertility history, ovarian reserve and embryo development of the three groups will be recorded. The samples will be detected ploidy by using next generation sequencing (NGS). Then, the investigators will choose embryo to transfer according to the embryo ploidy and follow the pregnancy outcomes after embryo transfer. Outcome 1. Concordance rate between non-invasive PGT-A and PGT-A 2. The relationship between morphological grade and ploidy of non-invasive PGT-A 3. IVF outcomes among non-invasive PGT-A, PGT-A and combined non-invasive PGT-A and PGT-A

Conditions

• Genetic Testing

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PGT-A	trophectoderm biopsy in blastocyst stage for euploidy testing using next generation sequencing platform
DIAGNOSTIC_TEST	non-invasive PGT-A	cell-free DNA collected from spent culture media for euploidy testing using next generation sequencing platform

Timeline

• Start date: 2021-03-24
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2021-04-23
• Last updated: 2024-08-02

Locations

1 site across 1 country: Taiwan