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.
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.
Presence of untreated uterine abnormalities, including uterine malformations or significant intrauterine pathology.
History of uterine surgery.
History of ovarian surgery.
Known metabolic disorders.
The study population consists of women with good reproductive prognosis undergoing in vitro fertilization (IVF) with intracytoplasmic sperm injection (ICSI) at My Duc Tan Binh Hospital and My Duc Phu Nhuan Hospital. Eligible participants are women aged 18 to 34 years with normal ovarian response, undergoing their first or second IVF cycle, and having at least one morphologically good-quality blastocyst available for frozen single embryo transfer. All participants receive standard IVF treatment according to routine clinical practice. Non-invasive preimplantation genetic testing for aneuploidy (NiPGT-A) is performed retrospectively using spent embryo culture media collected prior to embryo cryopreservation and is not used for clinical decision-making during the study.
Cohort
Prospective
Not listed
Ongoing Pregnancy/Live Birth Rate by NiPGT-A Result Groups
Presence of at least one intrauterine gestational sac with fetal cardiac activity confirmed by ultrasound at 12 weeks' gestation.
Positive Beta-hCG Rate by NiPGT-A Result Groups
Defined as serum human chorionic gonadotropin level greater than 25 mIU/mL
Clinical Pregnancy Rate by NiPGT-A Result Groups
Having at least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heartbeat activity
Miscarriage Rate by NiPGT-A Result Groups
The spontaneous loss of an intra-uterine pregnancy prior to or at 20 completed weeks of gestational age
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Mỹ Đức Hospital
Lead sponsor
My Duc Phu Nhuan Hospital HCMC, Vietnam
Collaborator
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