[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628395":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":27,"locations":37,"responsibleParty":52,"collaborators":11,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":11,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":78,"overallStatus":84,"whyStopped":11,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NICS-AI group","EXPERIMENTAL",null,[13],"Other: NICS-AI",{"label":15,"type":16,"description":11,"interventionNames":17},"Morphology group","ACTIVE_COMPARATOR",[18],"Other: Morphology group",[20,24],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"NICS-AI","1. Collection of spent blastocyst culture medium and embryo cryopreservation: after thorough removal of granulosa cells from the zona pellucida, Day-4 embryos are washed and the medium is refreshed. When the embryo reaches an expanded stage-4 blastocyst (about 180 um), pre-freeze collapse is performed and the culture medium is collected. Samples are stored at -20 ℃ pending testing; blastocysts are vitrified.\n2. Testing and scoring: samples undergo whole-genome amplification, library preparation, and sequencing. An AI-assisted model integrates sequencing results (including CNV resolution, mosaicism, euploidy\u002Fsex chromosome status, number of abnormal chromosomes), morphology grade, and day of blastulation to generate a composite implantation potential score (reported as \\\u003C10 or 10-66).\n3. Frozen-thawed single blastocyst transfer: embryos are prioritized for transfer from highest to lowest composite score. If scores are identical, embryos are prioritized by cryopreservation order.",[9],{"type":6,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"1. When the embryo reaches an expanded stage-4 blastocyst (about 180 um), pre-freeze collapse is performed and the culture medium is collected. Samples are stored at -20 C pending testing; blastocysts are vitrified.\n2. Single-blastocyst transfer in frozen-thawed cycles, determined solely by the day of blastulation and morphological grading:\n\n   i) Day 5 blastocysts are prioritized over Day 6 blastocysts (Day 5 \\> Day 6); ii) For blastocysts formed on the same day, prioritization follows this order: 6AA \\> 6BA \\> 6AB \\> 5AA \\> 5BA \\> 5AB \\> 4AA \\> 4BA \\> 4AB \\> 6BB \\> 5BB \\> 4BB \\> 6CA \\> 5CA \\> 6CB \\> 5CB \\> 4CA \\> 4CB \\> 6AC \\> 5AC \\> 6BC \\> 5BC \\> 4AC \\> 4BC; iii) If both the day of blastulation and the morphological grade are identical, embryos are transferred according to the order of cryopreservation (e.g., based on the cryo-straw identification number).\n3. For all enrolled patients, the study-designated (enrolled) blastocysts are prioritized for transfer.",[15],[28,33],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},"Ping Yuan, Doctor","CONTACT","+8613751885713","kekeyp1983@163.com",{"name":34,"role":30,"phone":35,"phoneExt":11,"email":36},"Haijing Zhao","+8615217456163","zhaohj0502@163.com",[38],{"facility":5,"status":11,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Guangzhou","Guangdong","510120","China","CN",{"type":45,"coordinates":46},"Point",[47,48],113.25,23.11667,{"lat":48,"lon":47},[51],{"name":29,"role":30,"phone":31,"phoneExt":11,"email":32},{"type":53,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100628395","noninvasive-implantation-potential-vs-morphology-based-selection-in-ivf-single-blastocyst-transfer-100628395",false,"NCT07461077","Noninvasive Implantation Potential vs Morphology-Based Selection in IVF Single Blastocyst Transfer","Clinical Outcomes of Non-invasive Embryo Implantation Potential Assessment Versus Conventional Morphological Selection for Single Blastocyst Transfer Following Conventional IVF: A Multicenter Randomized Controlled Trial","NICSAI-SBT-RCT","Inclusion Criteria:\n\n1. Conventional IVF insemination;\n2. Meeting either of the following:\n\n   1. Advanced maternal age: female age 35-43 years;\n   2. Recurrent miscarriage: ≥2 spontaneous pregnancy losses (\\\u003C28 gestational weeks), including biochemical pregnancy (hCG \\>25 IU\u002FL) ;\n3. 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;\n4. Willingness to undergo frozen-thawed single-blastocyst transfer;\n5. At least two blastocysts formed on Day 5\u002FDay 6 from 2PN fertilization, with morphological grading ≥4BC\u002F4CB;\n6. Provision of written informed consent.\n\nExclusion Criteria:\n\n1. Any use of intracytoplasmic sperm injection-based fertilization, including but not limited to ICSI, TESA, and PGT-related cycles;\n2. Known monogenic disorders or chromosomal abnormalities at enrollment;\n3. Patients who use donated eggs to achieve pregnancy;\n4. Definite conditions affecting uterine cavity anatomy or endometrial receptivity, such as untreated uterine malformations (e.g., septate uterus, unicornuate uterus, didelphys uterus) or untreated hydrosalpinx;\n5. Contraindications to pregnancy or to assisted reproductive technology;\n6. Any other condition deemed by the investigators to make the participant unsuitable for this study.","FEMALE","20 Years","43 Years",{"count":66,"type":67},520,"ESTIMATED","INTERVENTIONAL",[70],"NA","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.\n\nMethods: 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 \\\u003C28 gestational weeks, including biochemical pregnancy with serum hCG \\>25 IU\u002FL). They must consent to blastocyst culture\u002Fvitrification and frozen-thawed single blastocyst transfer (SBT), and have ≥2 Day-5\u002FDay-6, 2PN-derived blastocysts with morphology grade ≥4BC\u002F4CB at randomization. Key exclusions include any ICSI-based fertilization or PGT-related procedures, known genetic disease meeting PGT indications, donor oocytes, untreated uterine anomalies\u002Fhydrosalpinx, or contraindications to pregnancy\u002FART.\n\nRandomization\u002Finterventions: 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).\n\nOutcomes\u002Fanalysis: 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 (\\\u003C12 weeks, excluding biochemical pregnancy), ongoing pregnancy to 12 weeks, and cumulative pregnancy\u002Flive birth outcomes within 1 year (≤3 SBTs from one retrieval). Safety includes fetal malformations and neonatal outcomes through 1 year postpartum.",[73,74,75,76,77],"Advanced Age","Recurrent Pregnancy Loss(RPL)","Infertility (IVF Patients)","Sequence Analysis","Embryo Quality",[79,80,81,82,83],"NICS","AI","single embryo transfer","live birth rate","Embryo quality","NOT_YET_RECRUITING","2026-03-04",{"date":87,"type":88},"2026-03-10","ACTUAL",{"date":90,"type":67},"2026-04-30",{"date":92,"type":67},"2032-03-31",{"name":5,"class":6},1]