[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559982":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":59,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":26,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":86,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Nanjing University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment group","EXPERIMENTAL","The r-hFSH starting dose will be based on the patient's profile and physician's experience. r-hLH will be added at a ratio of 2:1 starting from day 1 of r-hFSH administration; the dose of r-hFSH during COS will be adjusted by the physician based on clinical experience and the patient's ovarian response, and the r-hFSH: r-hLH dose will be 2:1, continuing to 24\\~48 hours prior to trigger drug injection.\n\nFor both groups, daily injection of 0.25 mg of cetrorelix (Cetrotide®, Merck Serono S.A.) will be administrated subcutaneously when at least one follicle with diameter ≥ 14 mm or serum LH level exceeds 10 IU\u002FL or LH level is 2 folder than basal LH level or P level exceeds 0.8 ng\u002Fml, continuing until ovulation triggering day. Cetrorelix can be administrated earlier in patients with advanced age or diminished ovarian reserve according to judgment of clinicians.",[13,14],"Drug: Recombinant Human Follitropin Alfa Solution for Injection (Gonal-f®)","Drug: Recombinant Human Lutropin alfa for Injection (r-hLH, Luveris®)",{"label":16,"type":17,"description":18,"interventionNames":19},"Control group","ACTIVE_COMPARATOR","r-hFSH alone will be administrated for ovarian stimulation. The r-hFSH starting dose will be based on the patient's profile and physician's experience. The dose of r-hFSH during COS will be adjusted by the physician based on clinical experience and the patient's ovarian response, continuing to 24\\~48 hours prior to trigger drug injection.\n\nFor both groups, daily injection of 0.25 mg of cetrorelix (Cetrotide®, Merck Serono S.A.) will be administrated subcutaneously when at least one follicle with diameter ≥ 14 mm or serum LH level exceeds 10 IU\u002FL or LH level is 2 folder than basal LH level or P level exceeds 0.8 ng\u002Fml, continuing until ovulation triggering day. Cetrorelix can be administrated earlier in patients with advanced age or diminished ovarian reserve according to judgment of clinicians.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Recombinant Human Follitropin Alfa Solution for Injection (Gonal-f®)","As a r-hFSH agent, Gonal-f® is used for COS. It is a prefilled ready to use pen device containing follitropin alfa for injection and is designed for subcutaneous self-administration by patients undergoing COS for ART. It is available as dose presentations of 150 IU and 450 IU. The investigators and\u002For his\u002Fher delegate\u002Fs will explain the use of Gonal-f® prefilled pen. Gonal-f® will be prescribed by the investigator based on clinical diagnosis and treatment routines, and will not be provided free of charge.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Recombinant Human Lutropin alfa for Injection (r-hLH, Luveris®)","This product is a white freeze-dried powder and a colorless and clear injection solvent, and stored away from light under 25℃ in the original packaging. Luveris® will be provided free of charge.",[16,9],[32],{"name":33,"affiliation":34,"role":35},"Haiming Xia, Dr.","The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Haixiang Sun, Dr.","CONTACT","13851622008","stevensunz@163.com",[43],{"facility":44,"status":26,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Nanjing Drum Tower Hospital","Nanjing","Jiangsu","210008","China","CN",{"type":51,"coordinates":52},"Point",[53,54],118.77778,32.06167,{"lat":54,"lon":53},[57],{"name":38,"role":39,"phone":58,"phoneExt":26,"email":26},"+8683106666",{"type":35,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Li-jun Ding","Director of Reproductive Medicine Department","100559982","phase-4-potential-benefit-of-r-hlh-addition-in-patients-aged-35-to-40-under-ovarian-stimulation-treatment-100559982",false,"NCT06571214","Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment","An Exploratory, Randomized, Open-label, Controlled Study to Evaluate the Potential Benefit of r-hLH Addition in Patients Aged 35 to 40 Under Ovarian Stimulation Treatment","Inclusion Criteria:\n\n* Age 35 to 40 (including 40)\n* 18.5\\\u003CBMI\\\u003C28 kg\u002Fm2\n* AFC up to 14\n* First or second ART cycle\n* Planned for ovarian stimulation with GnRH-antagonist for down-regulation\n* Ejaculated sperm\n\nExclusion Criteria:\n\n* Contraindications to ART treatment\n* History of two or more spontaneous miscarriages\n* History of two or more implantation failures after fresh or frozen-warmed embryo transfers\n* Diagnosis of severe endometriosis\n* Patients with endocrine and metabolic diseases (diabetes mellitus, hypogonadotropic amenorrhea, genital system tumors, hyperprolactinemia, etc.)\n* Confirmed chromosomal abnormalities","FEMALE","35 Years","40 Years",{"count":73,"type":74},300,"ESTIMATED","INTERVENTIONAL",[77],"PHASE4","This will be an exploratory, prospective, randomized, open-label and controlled trial to evaluate the potential benefit of r-hFSH:r-hLH 2:1 co-treatment starting from COS D1 versus r-hFSH alone in patients aged 35 to 40 under ovarian stimulation treatment.\n\nAfter signing informed consent form (ICF), all eligible participants will be randomly assigned in a 1:1 ratio to either treatment or control group, and GnRH antagonist protocol will be used in both treatment and control groups.",[80],"Infertility",[82,83,84,85],"recombinant human LH","recombinant human FSH","ovarian stimulation treatment","advanced maternal age population","NOT_YET_RECRUITING","2024-08-25",{"date":89,"type":90},"2024-08-27","ACTUAL",{"date":92,"type":74},"2024-09-01",{"date":94,"type":74},"2027-01-30",{"name":5,"class":6},1]