Correlation Of Clinical Outcomes After Transfer Of Good-Quality Morphology Embryos In Patients With A Favorable Prognosis And Non-Invasive Preimplantation Genetic Testing For Aneuploidy (NiPGT-A) Results

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Conditions studied: Infertility (IVF Patients), Clinical Pregnancy After Single Embryo Transfer, Embryo Diagnosis and Selection

In brief

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.

Key facts

Study ID

NCT07700602

Run by

Mỹ Đức Hospital

People needed

200

Starts

2026-08-01

Expected to finish

2029-12-31

Last updated by the study team

2026-07-14

Who can join

Age: 18 and older, up to 34. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.
• Normal semen parameters of the male partner.
• Willing to undergo non-invasive preimplantation genetic testing for aneuploidy (NiPGT-A) using spent embryo culture media.
• Agree to vitrification of a single morphologically best-quality blastocyst and to undergo frozen single embryo transfer.
• Able and willing to provide written informed consent.

You may not qualify if…

• Presence of untreated uterine abnormalities, including uterine malformations or significant intrauterine pathology.
• History of uterine surgery.
• History of ovarian surgery.
• Known metabolic disorders.
• Use of donor oocytes.
• In vitro maturation (IVM) cycles.
• Participation in another clinical study during the study period.
• Patients who do not undergo frozen single embryo transfer.

Where it is running

• My Duc Hospital — Ho Chi Minh City, Vietnam

Full record on ClinicalTrials.gov

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