NCT04339166

Embryo Selection by Noninvasive Preimplantation Genetic Test

A Multicenter Clinical Study on Embryo Selection by Using the Ploidy of Cell Free DNA in Embryo Culture Medium

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,152 (actual)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: Female
• Age: 35 Years – 42 Years
• Healthy volunteers: Accepted

Summary

The objective of this study is to explore whether non-invasive chromosome screening (NICS) can be used as an effective indicator for embryos selection besides morphology through a multicenter randomized controlled trial, by comparing the differences of live birth rate, pregnancy rate and miscarriage rate between the two groups of embryo selection by "NICS+ morphology" and embryo selection only by "morphology" in IVF cycle.

Detailed description

Chromosomal abnormalities commonly exist in early human embryos, and often cause embryo implantation failure and pregnancy loss in in-vitro fertilization (IVF) treatments. Preimplantation genetic testing for aneuploidies (PGT-A) by comprehensive chromosome screening (CCS) has been widely applied in IVF practices to select embryos with normal ploidy. Although multiple clinical trials have demonstrated improved clinical outcomes with PGT-A, it's in controversial for whether PGT-A is truly worthwhile to be offered to all IVF patients. One of the main concerns is that it involves an embryo biopsy procedure, which is invasive and the long-term safety issue of the embryo biopsy remains to be fully investigated. In recent years, researchers have found that the spent medium of embryo culture contains trace amount of cell-free DNA, which may reflect the ploidy of the embryo. The non-invasive chromosome screening (NICS) approach utilizing spent culture medium samples has been evaluated in studies. However, the clinical value of NICS as a new effective indicator to evaluate embryo competence so far has not been justified by randomized clinical trials. The main purpose of this project is to verify whether NICS can be used as a new effective indicator for evaluating embryo developmental potential through multi-center, randomized clinical trials

Conditions

• Infertility
• Chromosome Abnormality

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Non-invasive chromosome screening（NICS）	NICS is noninvasive chromosome screening approach to analysis the euploidy by free DNA in embryo culture medium

Timeline

• Start date: 2020-04-16
• Primary completion: 2024-02-28
• Completion: 2024-08-06
• First posted: 2020-04-09
• Last updated: 2025-12-11

Locations

13 sites across 1 country: China