[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-age\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-age":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,84],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":4},"100630660","the-impact-of-assisted-hatching-on-pregnancy-outcomes-after-vitrified-warmed-embryo-transfer-in-advanced-age-patients-100630660",false,"NCT07490561","The Impact of Assisted Hatching on Pregnancy Outcomes After Vitrified-Warmed Embryo Transfer in Advanced-age Patients","The Impact of Laser-Assisted Hatching on Pregnancy Outcomes After Vitrified-Warmed Embryo Transfer in Advanced-age Patients: A Randomized Controlled Trial","Inclusion Criteria:\n\n* 1: Female age ≥ 35 years\n* 2: First or second vitrified-warmed embryo transfer cycle\n* 3: Quality of embryos for transfer meeting the criteria: Grade I, II, CP or above (cleavage-stage embryos); Grade 4BC\u002FCB or above (blastocysts)\n* 4: Provide written informed consent\n\nExclusion Criteria:\n\n* 1: Use of donor oocytes or sperm, or planned preimplantation genetic testing (PGT)\n* 2: Severe immune or chromosomal abnormalities\n* 3: Uterine cavity abnormalities (i.e., adenomyosis, submucous uterine fibroids, hydrosalpinx, uterine septum, and endometrial polyps)\n* 4: Embryos with an abnormal zona pellucida\n* 5: Complicated with severe underlying diseases (e.g., uncontrolled hypertension\u002Fdiabetes mellitus, active malignant tumors)\n* 6: A history of recurrent implantation failure (≥2 cycles) or recurrent miscarriage (≥2 episodes)","FEMALE","35 Years","50 Years",{"count":20,"type":21},916,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to evaluate the effect of laser assisted hatching (LAH) on pregnancy outcomes, with live birth rate as the primary outcome, in advanced age infertile women aged ≥35 years who are undergoing non-donor IVF\u002FICSI cycles and planning vitrified-warmed embryo transfer. It also aims to monitor the safety of LAH and assess various secondary pregnancy and neonatal outcomes. The main questions it aims to answer are:\n\nDoes laser assisted hatching improve the live birth rate in advanced age women undergoing vitrified-warmed embryo transfer? Does laser assisted hatching affect secondary outcomes including implantation rate, biochemical pregnancy rate, clinical pregnancy rate, ectopic pregnancy rate, ongoing pregnancy rate, miscarriage rate, multiple pregnancy rate, preterm birth rate, and rates of obstetric and neonatal complications as well as congenital anomalies? Researchers will compare the Laser Assisted Hatching (LAH) Group to the Control Group (without LAH) to see if LAH can improve pregnancy outcomes in the study population.\n\nParticipants will:\n\n* Be randomly assigned to either the LAH Group or the Control Group at a 1:1 ratio, stratified by age (\\\u003C40 years\u002F≥40 years) and embryo stage (cleavage stage\u002Fblastocyst) using stratified block randomization.\n* Undergo the first or second frozen-thawed embryo transfer cycle, with transferred embryos meeting the quality criteria (cleavage-stage embryos: Grade I, Grade II, or CP and above; blastocysts: 4BC\u002FCB and above).\n* Receive embryo vitrification and warming after routine fertilization and culture; LAH Group will undergo LAH (thinning zona pellucida for cleavage-stage embryos, removing 1\u002F4-1\u002F3 of zona pellucida circumference for blastocysts) in G2 medium after embryo thawing, while Control Group will not receive assisted hatching.\n* Have endometrial preparation by natural, ovulatory, or hormone replacement cycles as appropriate, and 1-2 viable embryos will be transferred under ultrasound guidance within 3 hours after thawing, followed by routine luteal support after transfer.\n* Complete follow-up at multiple time points: 12-15 days after embryo transfer (serum β-hCG test), 28 days after embryo transfer (transvaginal ultrasound), 12 weeks of gestation (ultrasound), 28 weeks of gestation (ultrasound), and 1 month after delivery (collection of delivery and neonatal information).\n* Provide demographic, clinical, and embryological baseline data, as well as various outcome data during the study period.\n* Undergo regular monitoring of vital signs, laboratory test results, and adverse events, with key prevention and control of specific risks related to LAH such as embryo damage and multiple pregnancy.",[27,28],"Assisted Hatching","Advanced Age",[30,31,32,33,34,35,36],"Laser-Assisted hatching;","Vitrified-warmed embryo transfer","Frozen embryo transfer","Advanced maternal age","Infertility","IVF\u002FICSI","Live birth","NOT_YET_RECRUITING","2026-03-18",{"date":40,"type":41},"2026-03-24","ACTUAL",{"date":43,"type":21},"2026-03-16",{"date":45,"type":21},"2027-12-31",{"name":47,"class":48},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":68,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100628395","noninvasive-implantation-potential-vs-morphology-based-selection-in-ivf-single-blastocyst-transfer-100628395","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.","20 Years","43 Years",{"count":60,"type":21},520,[24],"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.",[28,64,65,66,67],"Recurrent Pregnancy Loss(RPL)","Infertility (IVF Patients)","Sequence Analysis","Embryo Quality",[69,70,71,72,73],"NICS","AI","single embryo transfer","live birth rate","Embryo quality","2026-03-04",{"date":76,"type":41},"2026-03-10",{"date":78,"type":21},"2026-04-30",{"date":80,"type":21},"2032-03-31",{"name":82,"class":48},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":83},"100598036","adipose-stem-cell-mitochondria-supplementation-to-oocytes-ascent-100598036","NCT07066267","Adipose Stem Cell Mitochondria Supplementation to Oocytes (ASCENT)","Clinical Application of Autologous Adipose Stem Mitochondria Transplantation to Oocytes for Improving Embryo Quality in Patients With Recurrent Pregnancy Failure","Inclusion Criteria:\n\n* Having at least three previous failed IVF trial\n* Specifically consented for to collect biopsies for Preimplantation generic testing for aneuploidy (PGTA) analysis\n* Specifically consented for to have single blastocyst transfer (recommended)\n* No major uterine or ovarian abnormalities\n* Specifically consented for to have all embryos frozen\n* Specifically consented for to collect adipose tissues from subcutaneous liposuction\n* BMI level level \\\u003C26kg\u002Fm2\n\nExclusion Criteria:\n\n* Ovarian endometriosis with Chocolate cysts (American Fertility Society (AFS)) classification type 3 and 4\n* Any medical contraindication oocyte retrieval or subsequent procedures Ovarian hyperstimulation syndrome Bleeding disorders Sex hormone allergies Severe emotional defect on injections\n* Severe sperm abnormalities\n* \\\u003C5 million\u002FmL motile sperm\n* Uterine structural anomalies\n* Polycystic ovaries\n* Premature ovarian failure","29 Years","39 Years",{"count":94,"type":21},20,[24],"The purpose of this study is to investigate the potential of autologous adipose stem cell (ASC) mitochondrial transfer (ASCENT) to oocytes along with intracytoplasmic sperm injection (ICSI)as a means of enhancing embryo development and improving the success rate of in patients with a history of multiple IVF failures. Embryo quality plays a crucial role in determining the success of assisted reproductive technologies and directly contributes to repeated pregnancy failures. Several factors, including age, physiological conditions, genetics, and environmental influences, can significantly impact embryo quality. Oocytes, the largest cells in the human body, are heavily reliant on mitochondria. Mitochondria's role in providing energy for oocytes is crucial, and insufficient energy production has been linked to poor oocyte and embryo quality. Some human studies have shown that increasing oocyte mitochondrial mass can improve embryo quality in patients who have experienced repeated IVF failures.",[98,99,100,101,28],"Female Infertility","Oocyte Competence","Mitochondria","Recurent Implantation Failures",[103,104,105,106,107],"mitochondria","mitochondria transplantation","Adipose stem cell","oocyte","Female infertility","RECRUITING","2025-07-14",{"date":111,"type":41},"2025-07-17",{"date":113,"type":41},"2025-04-25",{"date":115,"type":21},"2026-12-31",{"name":117,"class":118},"Sunkaky Medical Cooperation","INDUSTRY"]