[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602813":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":44,"centralContacts":49,"locations":60,"responsibleParty":79,"collaborators":54,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":54,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":63,"whyStopped":54,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Nanjing University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Recombinant LH Supplementation Group","EXPERIMENTAL","Participants receive controlled ovarian hyperstimulation (COH) using a long-acting GnRH agonist (triptorelin 3.75 mg) for pituitary downregulation, followed by recombinant FSH (rFSH) combined with recombinant LH (rLH) at a ratio of 2:1 starting on stimulation day. rLH administration continues throughout the stimulation phase, with gonadotropin doses adjusted based on follicular growth and hormone monitoring. Trigger is given when 2-3 leading follicles reach ≥18 mm, followed by oocyte retrieval, IVF\u002FICSI, and embryo quality assessment.",[13,14,15],"Drug: Recombinant Luteinizing Hormone (rLH)","Drug: Recombinant Follicle-Stimulating Hormone (rFSH)","Drug: Gonadotropin-Releasing Hormone Agonist (GnRH-a)",{"label":17,"type":18,"description":19,"interventionNames":20},"Conventional rFSH-Only Group","ACTIVE_COMPARATOR","Participants receive the same long-acting GnRH agonist downregulation and rFSH stimulation protocol as the experimental arm, but without rLH supplementation. Only rFSH is used during COH, with dose adjustments according to follicular development and hormone levels. Trigger, oocyte retrieval, IVF\u002FICSI, and embryo assessment follow the same procedures as in the experimental arm.",[14,15],[22,30,37],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Recombinant Luteinizing Hormone (rLH)","Recombinant LH administered subcutaneously in combination with recombinant FSH (rFSH) at a ratio of 2:1 starting on stimulation day, continued throughout controlled ovarian hyperstimulation. Dosage adjusted according to follicular growth and serum hormone levels.",[9],[28,29],"lutropin alfa","Luveris",{"type":23,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Recombinant Follicle-Stimulating Hormone (rFSH)","Recombinant FSH administered subcutaneously for controlled ovarian hyperstimulation after pituitary downregulation with a long-acting GnRH agonist. Dosage adjusted based on follicular development and hormone monitoring.",[17,9],[35,36],"follitropin alfa","Gonal-F",{"type":23,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Gonadotropin-Releasing Hormone Agonist (GnRH-a)","Long-acting GnRH agonist (3.75 mg) administered subcutaneously on menstrual cycle day 2-4 for pituitary downregulation before controlled ovarian hyperstimulation.",[17,9],[42,43],"triptorelin","Diphereline",[45],{"name":46,"affiliation":47,"role":48},"慧 Jiang, PhD","Nanjing Drum Tower Hospital: Nanjing University Medical School Affiliated Nanjing Drum Tower Hospital","PRINCIPAL_INVESTIGATOR",[50,56],{"name":51,"role":52,"phone":53,"phoneExt":54,"email":55},"Yue Jiang, PhD","CONTACT","+8613814122872",null,"jiangyue85@163.com",{"name":57,"role":52,"phone":58,"phoneExt":54,"email":59},"Hui Zhang, PhD","+8618262637731","hellozhanghui@sina.cn",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Nanjing Drum Tower Hospital, Nanjing University Medical School","RECRUITING","Nanjing","Jiangsu","210008","China","CN",{"type":70,"coordinates":71},"Point",[72,73],118.77778,32.06167,{"lat":73,"lon":72},[76,77,78],{"name":51,"role":52,"phone":53,"phoneExt":54,"email":55},{"name":57,"role":52,"phone":58,"phoneExt":54,"email":59},{"name":51,"role":48,"phone":54,"phoneExt":54,"email":54},{"type":48,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":54,"oldOrganization":54},"Li-jun Ding","Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University","100602813","extra-luteinizing-hormone-improve-embryo-quality-in-ivf-patients-with-low-lh-during-long-gnrh-agonist-treatment-100602813",false,"NCT07128394","Extra Luteinizing Hormone Improve Embryo Quality in IVF Patients With Low LH During Long GnRH-Agonist Treatment","Exogenous Luteinizing Hormone Supplementation to Improve Embryo Quality in Patients With Excessive LH Suppression During a Long GnRH-Agonist Protocol: A Randomized Controlled Trial","ELH-IVF","Inclusion Criteria:\n\n* Women aged 20 to 37 years (inclusive). Diagnosed with infertility and undergoing in vitro fertilization\u002Fintracytoplasmic sperm injection (IVF\u002FICSI) treatment using the long-acting GnRH agonist protocol.\n\nSerum luteinizing hormone (LH) level \\\u003C0.5 U\u002FL after pituitary downregulation. Normal uterine cavity as confirmed by hysteroscopy, sonohysterography, or hysterosalpingography within 6 months.\n\nWritten informed consent provided prior to participation.\n\nExclusion Criteria:\n\n* Polycystic ovary syndrome (PCOS). History of recurrent implantation failure (RIF). Presence of endometriosis or adenomyosis. History of ovarian surgery. Ovarian cysts ≥3 cm or with suspected malignancy. Poor ovarian reserve (antral follicle count \\\u003C5, anti-Müllerian hormone \\\u003C1.1 ng\u002FmL, or baseline FSH \\>10 IU\u002FL).\n\nChromosomal abnormalities in either partner. Systemic diseases such as uncontrolled hypertension, diabetes, thyroid disorders, or autoimmune diseases.\n\nContraindications to ovarian stimulation medications or pregnancy.","FEMALE","20 Years","37 Years",{"count":94,"type":95},590,"ESTIMATED","INTERVENTIONAL",[98],"NA","This randomized controlled trial aims to evaluate whether supplementation with exogenous luteinizing hormone (LH) can improve embryo quality in patients undergoing in vitro fertilization (IVF) with a long gonadotropin-releasing hormone agonist (GnRH-a) protocol who have excessive suppression of LH. Eligible participants will be randomly assigned to receive either exogenous LH supplementation or standard care. The primary outcome is embryo quality, and secondary outcomes include pregnancy rates and safety assessments. The study is conducted at Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University.",[101,102],"Infertility, Female","Luteinizing Hormone (LH)",[104,105,106,107,108,109],"Luteinizing Hormone","Long GnRH Agonist Protocol","Excessive LH Suppression","Controlled Ovarian Stimulation","In Vitro Fertilization","Embryo Quality","2025-08-13",{"date":112,"type":113},"2025-08-19","ACTUAL",{"date":115,"type":113},"2024-02-01",{"date":117,"type":95},"2026-11-30",{"name":5,"class":6},1]