[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559982":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":67,"studyPopulation":60,"armGroups":68,"interventions":81,"overallOfficials":91,"centralContacts":96,"locations":102,"responsibleParty":119,"collaborators":60,"id":122,"slug":60,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":60,"eligibilityCriteria":127,"healthyVolunteers":123,"sex":128,"minAge":129,"maxAge":130,"enrollmentInfo":131,"targetDuration":60,"studyType":134,"phases":135,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":145,"whyStopped":60,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},{"fullName":5,"class":6},"Nanjing University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":60},[9],{"measure":10,"description":11,"timeFrame":12},"Good quality embryo rate (cleavage stage)","Cleavage stage good-quality embryos are defined as embryos derived from normally fertilized zygotes with 7\\~9 cells on day 3 post-fertilization, stage-specific cell size, less than 10% fragmentation, and no multinucleation. Cleavage stage good-quality embryo rate is defined as the number of cleavage stage good-quality embryos divided by the number of normally fertilized zygotes. Embryos will be assessed by two independent experienced embryologists to minimize intra-observation variability.","Day 3 after fertilization",[14,18,21,25,29,33,36,40,43,47,50,53,56],{"measure":15,"description":16,"timeFrame":17},"Number of oocytes","Number of oocytes is defined as the total number of oocytes obtained through transvaginal ultrasound guided puncture on the day of OPU. All follicles with an estimated diameter of ≥12 mm should be punctured.","24 hours after Oocytes pick up",{"measure":19,"description":20,"timeFrame":17},"Number of MII oocytes (analyzed in ICSI subgroup only)","Number of MII oocyte is defined as the total number of an oocyte at metaphase of meiosis II, exhibiting the first polar body and with the ability to become fertilized",{"measure":22,"description":23,"timeFrame":24},"Total r-hFSH dose","Total r-hFSH dose is defined as the total dose of r-hFSH used for subcutaneous injection during COS period.","24 hours after ovulation triggering",{"measure":26,"description":27,"timeFrame":28},"Fertilization rate","* IVF normal fertilization rate is defined as the number of oocytes with 2PN and 2PB divided by the number of COCs inseminated.\n* ICSI normal fertilization rate is defined as the number of oocytes with 2PN and 2PB divided by the number of MII oocytes injected.","24 hours after fertilization",{"measure":30,"description":31,"timeFrame":32},"Blastocyst development rate","Blastocyst development rate is defined as the proportion of blastocysts observed at 116 ± 2 h post-insemination as a function of the number of normally fertilized oocytes.","5 days after fertilization, up to 7 days",{"measure":34,"description":35,"timeFrame":32},"Utilizable embryo rate","Utilizable embryo rate is defined as the number of embryos (or blastocysts) suitable for transfer or cryopreservation as a function of the number of normally fertilized (2PN) oocytes observed on Day 1.",{"measure":37,"description":38,"timeFrame":39},"Implantation rate","Implantation rate is defined as the number of gestational sacs observed divided by the number of embryos transferred using transvaginal ultrasound 4\\~6 weeks after embryo transfer.","At 4-6 weeks of amenorrhea after customized timing of embryo transfer",{"measure":41,"description":42,"timeFrame":39},"Clinical pregnancy rate (per transfer cycle and per oocyte retrieval cycle)","Clinical pregnancy rate is defined as the number of clinical pregnancies expressed per 100 initiated cycles, aspiration cycles, or embryo transfer cycles. Clinical pregnancy is defined as the presence of gestational sac (intrauterine or ectopic) using ultrasound examination at 4\\~6 weeks after embryo transfer.",{"measure":44,"description":45,"timeFrame":46},"Ongoing pregnancy rate","Ongoing pregnancy rate is defined as the number of intrauterine pregnancies continued for 12 gestational weeks divided by the number of embryo transfer cycles.","At 12 weeks of amenorrhea after customized timing of embryo transfer",{"measure":48,"description":49,"timeFrame":28},"Ovarian sensitivity index (OSI)","OSI is defined as the total r-hFSH dose divided by the number of oocytes retrieved.",{"measure":51,"description":52,"timeFrame":28},"Follicular output rate (FORT)","FORT is defined as the number of pre-ovulatory follicles (16\\~22 mm) on the day of trigger divided by the AFC (3\\~8 mm)",{"measure":54,"description":55,"timeFrame":28},"Follicle oocyte index (FOI)","FOI is defined as the number of total oocytes retrieved divided by the AFC",{"measure":57,"description":58,"timeFrame":59},"Safety Assessments","AE, SAE and OHSS","During the COS cycle (average cycle range 11 days), Up to 12 weeks after transfer",null,{"allocation":62,"interventionModel":63,"interventionModelDescription":60,"primaryPurpose":64,"observationalModel":60,"timePerspective":60,"maskingInfo":65},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":66,"maskingDescription":60,"whoMasked":60},"NONE","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.\n\n1. Treatment group: 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.\n2. Control group: 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\nThe estimated treatment duration is 11 days from the first day of COS until 24\\~48 h prior to trigger drug injection, and this may vary depending on individual circumstances.\n\nFollicular development, serum E2 and P levels will be monitored during COS according to the investigator site's ART practice until the criteria to administer trigger drug are met to induce final oocyte maturation. Trigger drug administration is to be performed according to the site's routine clinical practice.\n\nOocyte pick-up (OPU), IVF\u002FICSI, ET, and luteal phase support (LPS) will be performed according to the site's routine practice. LPS will be started after oocyte retrieval in fresh embryo transfer.",[69,76],{"label":70,"type":71,"description":72,"interventionNames":73},"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.",[74,75],"Drug: Recombinant Human Follitropin Alfa Solution for Injection (Gonal-f®)","Drug: Recombinant Human Lutropin alfa for Injection (r-hLH, Luveris®)",{"label":77,"type":78,"description":79,"interventionNames":80},"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.",[75],[82,87],{"type":83,"name":84,"description":85,"armGroupLabels":86,"otherNames":60},"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.",[70],{"type":83,"name":88,"description":89,"armGroupLabels":90,"otherNames":60},"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.",[77,70],[92],{"name":93,"affiliation":94,"role":95},"Haiming Xia, Dr.","The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","PRINCIPAL_INVESTIGATOR",[97],{"name":98,"role":99,"phone":100,"phoneExt":60,"email":101},"Haixiang Sun, Dr.","CONTACT","13851622008","stevensunz@163.com",[103],{"facility":104,"status":60,"city":105,"state":106,"zip":107,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":115,"contacts":116},"Nanjing Drum Tower Hospital","Nanjing","Jiangsu","210008","China","CN",{"type":111,"coordinates":112},"Point",[113,114],118.77778,32.06167,{"lat":114,"lon":113},[117],{"name":98,"role":99,"phone":118,"phoneExt":60,"email":60},"+8683106666",{"type":95,"investigatorFullName":120,"investigatorTitle":121,"investigatorAffiliation":5,"oldNameTitle":60,"oldOrganization":60},"Li-jun Ding","Director of Reproductive Medicine Department","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":132,"type":133},300,"ESTIMATED","INTERVENTIONAL",[136],"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.",[139],"Infertility",[141,142,143,144],"recombinant human LH","recombinant human FSH","ovarian stimulation treatment","advanced maternal age population","NOT_YET_RECRUITING","2024-08-25",{"date":148,"type":149},"2024-08-27","ACTUAL",{"date":151,"type":133},"2024-09-01",{"date":153,"type":133},"2027-01-30",{"name":5,"class":6},1]