About this trial
Non-invasive preimplantation genetic testing for aneuploidy (NiPGT-A) is an emerging approach that analyzes embryonic cell-free DNA (cfDNA) released into the spent culture medium (SCM) to assess chromosomal status without performing trophectoderm biopsy. This technique has the potential to reduce procedural invasiveness and eliminate biopsy-related risks while providing additional information for embryo selection in assisted reproductive technology (ART). However, the clinical value of NiPGT-A remains uncertain because available evidence is limited and largely derived from observational studies, with few studies reporting live birth outcomes.
This prospective observational study aims to evaluate the correlation between NiPGT-A results and clinical outcomes after single blastocyst transfer in patients with a favorable prognosis undergoing IVF/ICSI treatment. In this study, embryos with good morphological quality will undergo non-invasive sampling of spent culture medium for cfDNA analysis. NiPGT-A results will be categorized into four groups: no result, euploid, mosaic, and aneuploid. The study will compare pregnancy and birth outcomes across these groups to determine the clinical utility of NiPGT-A in embryo selection strategies.
Eligibility criteria
Qualifiers
Women undergoing in vitro fertilization (IVF) with intracytoplasmic sperm injection (ICSI).
Age younger than 35 years at the time of oocyte retrieval.
Good ovarian response, defined as having at least four good-quality embryos (Grade 1 or Grade 2) on Day 3 or later.
Undergoing the first or second IVF cycle.
Disqualifiers
Presence of untreated uterine abnormalities, including uterine malformations or significant intrauterine pathology.
History of uterine surgery.
History of ovarian surgery.
Known metabolic disorders.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Mỹ Đức Hospital
Lead sponsor
My Duc Phu Nhuan Hospital HCMC, Vietnam
Collaborator