[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615547":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":34,"locations":39,"responsibleParty":140,"collaborators":142,"id":150,"slug":151,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":152,"sex":158,"minAge":159,"maxAge":160,"enrollmentInfo":161,"targetDuration":25,"studyType":164,"phases":165,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":174,"whyStopped":25,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intracytoplasmic Sperm Injection (ICSI)","ACTIVE_COMPARATOR","All patients will receive controlled ovarian hyperstimulation (COH) treatment, which is performed by standard routines at each study center. The COH treatment includes either GnRH agonist protocol or GnRH antagonist protocol. Oocyte retrieval is scheduled for 36 (±2) hours after hCG injection. The retrieved cumulus oocyte complexes (COCs) will be allocated to undergo ICSI procedure according to the result of randomization.\n\nThe first embryo transfer is performed using fresh embryo transfer (if without contraindication), limited to transferring 1-2 cleavage embryos or 1 blastocyst. The remaining available embryos will be frozen.",[13],"Procedure: ICSI",{"label":15,"type":10,"description":16,"interventionNames":17},"Conventional in vitro fertilization (c-IVF)","All patients will receive controlled ovarian hyperstimulation (COH) treatment, which is performed by standard routines at each study center. The COH treatment includes either GnRH agonist protocol or GnRH antagonist protocol. Oocyte retrieval is scheduled for 36 (±2) hours after hCG injection. The retrieved cumulus oocyte complexes (COCs) will be allocated to undergo conventional IVF procedure according to the result of randomization.\n\nThe first embryo transfer is performed using fresh embryo transfer (if without contraindication), limited to transferring 1-2 cleavage embryos or 1 blastocyst. If the embryos in the IVF group are fertilized through different methods (some with late-RICSI), the first embryo transfer is limited to embryos fertilized through conventional IVF. The remaining available embryos will be frozen.",[18],"Procedure: IVF",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","ICSI","Insemination will be performed by using ICSI, 2 hours after oocyte retrieval. COCs will be stripped by using hyaluronidase. Only matured oocytes (MII stage) will be injected. Fertilization check will be performed at period of 16-18 hours after injection.\n\nOther standard assisted reproductive treatments are similar and parallel between two groups.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"IVF","Insemination will be performed by using conventional IVF, 2-4 hours after oocyte retrieval. Collected COCs will be inseminated (1-5×105 sperm\u002Fml) and cultured overnight in culture medium. Fertilization check will be performed at period of 16-18 hours after insemination.\n\nIf the IVF group experiences total fertilization failure or a fertilization rate of less than 25%, late rescue ICSI (Late-RICSI) will be performed on all MII stage oocytes using semen retained on the day of egg retrieval. The injection method is same as standard ICSI.\n\nOther standard assisted reproductive treatments are similar and parallel between two groups.",[15],[31],{"name":32,"affiliation":5,"role":33},"Min Jin, PhD","PRINCIPAL_INVESTIGATOR",[35],{"name":32,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+86-15925602121","min_jin@zju.edu.cn",[40,57,72,86,100,112,126],{"facility":41,"status":25,"city":42,"state":43,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Beijing Obstetrics and Gynecology Hospital, Capital Medical University","Beijing","Beijing Municipality","China","CN",{"type":47,"coordinates":48},"Point",[49,50],116.39723,39.9075,{"lat":50,"lon":49},[53],{"name":54,"role":36,"phone":55,"phoneExt":25,"email":56},"Xiaokui Yang","+86-010-52276699","yangxiaokui@ccmu.edu.cn",{"facility":58,"status":25,"city":59,"state":60,"zip":61,"country":44,"countryCode":45,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Huangshi Central Hospital","Huangshi","Hubei","435000",{"type":47,"coordinates":63},[64,65],115.04814,30.24706,{"lat":65,"lon":64},[68],{"name":69,"role":36,"phone":70,"phoneExt":25,"email":71},"Junling Wang","+86-0714-3189999","wangjunling225969@163.com",{"facility":73,"status":25,"city":74,"state":60,"zip":75,"country":44,"countryCode":45,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Renmin Hospital of Wuhan University","Wuhan","430060",{"type":47,"coordinates":77},[78,79],114.26667,30.58333,{"lat":79,"lon":78},[82],{"name":83,"role":36,"phone":84,"phoneExt":25,"email":85},"Qingzhen Xie","+86-027-88041911","rm001138@whu.edu.cn",{"facility":87,"status":25,"city":88,"state":60,"zip":89,"country":44,"countryCode":45,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Xiangyang Central Hospital","Xiangyang","441021",{"type":47,"coordinates":91},[92,93],112.14479,32.0422,{"lat":93,"lon":92},[96],{"name":97,"role":36,"phone":98,"phoneExt":25,"email":99},"Xuezhou Yang","+86-0710-3520081","dryangxz@163.com",{"facility":5,"status":25,"city":101,"state":102,"zip":103,"country":44,"countryCode":45,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"Hangzhou","Zhejiang","310052",{"type":47,"coordinates":105},[106,107],120.16142,30.29365,{"lat":107,"lon":106},[110],{"name":111,"role":36,"phone":37,"phoneExt":25,"email":38},"Min Jin",{"facility":113,"status":25,"city":114,"state":102,"zip":115,"country":44,"countryCode":45,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Jiaxing Maternity and Child Health Care Hospital","Jiaxing","314051",{"type":47,"coordinates":117},[118,119],120.75,30.7522,{"lat":119,"lon":118},[122],{"name":123,"role":36,"phone":124,"phoneExt":25,"email":125},"Weiping Fu","+86-0573-82066132","fuweiping2816@163.com",{"facility":127,"status":25,"city":128,"state":102,"zip":129,"country":44,"countryCode":45,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Ningbo Women & Children's Hospital","Ningbo","315012",{"type":47,"coordinates":131},[132,133],121.54945,29.87819,{"lat":133,"lon":132},[136],{"name":137,"role":36,"phone":138,"phoneExt":25,"email":139},"Liming Zhou","+86-0574-87083300","zhou.li.ming@163.com",{"type":141,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[143,144,145,146,148,149],{"name":73,"class":6},{"name":113,"class":6},{"name":127,"class":6},{"name":147,"class":6},"Beijing Obstetrics and Gynecology Hospital",{"name":87,"class":6},{"name":58,"class":6},"100615547","icsi-versus-conventional-ivf-in-couples-with-unexplained-infertility-100615547",false,"NCT07294027","ICSI Versus Conventional IVF in Couples With Unexplained Infertility","Intracytoplasmic Sperm Injection (ICSI) Versus Conventional in Vitro Fertilization (IVF) in Couples With Unexplained Infertility: a Multicenter, Open-label, Parallel-group, Randomized Controlled Trial","ICSI\u002FIVF-UI","Inclusion Criteria:\n\n1. Aged 20-38 years\n2. 18.5 \\\u003C BMI \\\u003C 24kg\u002Fm2\n3. Couples diagnosed with primary unexplained infertility:\n\n   * Regular menses or confirmed ovulation;\n\n     * Normal ovarian reserve;\n\n       * Patent fallopian tubes;\n\n         * Normal uterus and cervix;\n\n           * Normal endocrine profile;\n\n             * Semen analysis meeting WHO 6th edition criteria\n\n               * Normal karyotypes in both partners, no family history of genetic disorders\n4. First IVF\u002FICSI cycle\n5. Received GnRH agonist protocol or GnRH antagonist protocol\n6. Willing to provide informed consent and comply with follow-up\n\nExclusion Criteria:\n\n1. Preimplantation genetic testing (PGT) cycles\n2. In vitro maturation (IVM) cycles\n3. Using donor sperm\u002Foocyte\n4. Using frozen sperm\u002Foocyte\n5. \\\u003C5 oocytes retrieved\n6. Abnormal semen parameters on the day of oocyte retrieval\n7. High risk of tubal pathology or endometriosis without laparoscopic exclusion\n8. Untreated or poorly controlled endocrine disorders\n9. Abnormal immune related examinations\n10. Major organ\u002Fsystem disorders (cardiac, hepatic, renal, oncologic, hematologic, psychiatric, etc.)\n11. Concurrent participation in other clinical trials.","FEMALE","20 Years","38 Years",{"count":162,"type":163},848,"ESTIMATED","INTERVENTIONAL",[166],"NA","This multicenter, open-label, parallel-group, randomized controlled trial aims to compare the live birth rate, fertilization outcomes, other pregnancy outcomes and safety between ICSI and conventional IVF among couples with unexplained infertility in China.",[169],"Unexplained Infertility",[171,172,173],"Unexplained infertility","Conventional in vitro fertilization","Intracytoplasmic sperm injection","NOT_YET_RECRUITING","2025-12-07",{"date":177,"type":178},"2025-12-19","ACTUAL",{"date":180,"type":163},"2026-01-01",{"date":182,"type":163},"2028-07-30",{"name":5,"class":6},7]