Noninvasive Implantation Potential vs Morphology-Based Selection in IVF Single Blastocyst Transfer (NCT07461077) | Clinical Trial Compass
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Noninvasive Implantation Potential vs Morphology-Based Selection in IVF Single Blastocyst Transfer
China520 participantsStarted 2026-04-30
Plain-language summary
Background: Morphology-based embryo selection cannot detect aneuploidy, which is common in advanced maternal age and recurrent pregnancy loss. NICS-AI combines non-invasive chromosome screening (NICS) of cell-free DNA from spent blastocyst culture medium with AI integration of developmental day and morphology to improve embryo ranking.
Methods: This multicenter, single-blind, parallel randomized controlled trial will include 520 participants. Participants undergoing conventional IVF will be eligible if they meet either (i) female age 35-43 years or (ii) recurrent miscarriage (≥2 losses \<28 gestational weeks, including biochemical pregnancy with serum hCG \>25 IU/L). They must consent to blastocyst culture/vitrification and frozen-thawed single blastocyst transfer (SBT), and have ≥2 Day-5/Day-6, 2PN-derived blastocysts with morphology grade ≥4BC/4CB at randomization. Key exclusions include any ICSI-based fertilization or PGT-related procedures, known genetic disease meeting PGT indications, donor oocytes, untreated uterine anomalies/hydrosalpinx, or contraindications to pregnancy/ART.
Randomization/interventions: Participants will be randomized 1:1 to NICS-AI-guided selection or morphology-based selection. In the NICS-AI arm, culture-medium DNA is tested and an AI-derived composite implantation score ranks embryos; controls use morphology alone (tie-break by cryopreservation order).
Outcomes/analysis: The primary endpoint is live birth after the first SBT (delivery with ≥1 live-born infant per transfer cycle, per randomized participant). Secondary endpoints include first clinical pregnancy, early miscarriage (\<12 weeks, excluding biochemical pregnancy), ongoing pregnancy to 12 weeks, and cumulative pregnancy/live birth outcomes within 1 year (≤3 SBTs from one retrieval). Safety includes fetal malformations and neonatal outcomes through 1 year postpartum.
Who can participate
Age range20 Years – 43 Years
SexFEMALE
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Inclusion criteria
✓. Conventional IVF insemination;
✓. Meeting either of the following:
✓. Advanced maternal age: female age 35-43 years;
✓. Willingness to culture all Day 3 embryos to the blastocyst stage in the fresh cycle, or to culture ≥6 embryos (with at least one embryo ≥7 cells), and to cryopreserve all blastocysts as single-blastocyst vitrification;
✓. Willingness to undergo frozen-thawed single-blastocyst transfer;
✓. At least two blastocysts formed on Day 5/Day 6 from 2PN fertilization, with morphological grading ≥4BC/4CB;
✓. Provision of written informed consent.
Exclusion criteria
✕. Any use of intracytoplasmic sperm injection-based fertilization, including but not limited to ICSI, TESA, and PGT-related cycles;
What they're measuring
1
Live birth rate of the first frozen embryo transfer
Timeframe: At delivery (following the first frozen embryo transfer)
Trial details
NCT IDNCT07461077
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University