Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2026-01-01 @ 9:05 PM
Study NCT ID:
NCT06921395
Status:
RECRUITING
Last Update Posted:
2025-04-10
First Post:
2025-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase IV Study to Evaluate the Efficacy and Safety of Fang Le Shu Compared to Guo Na Fen for Controlled Ovarian Stimulation in Infertile Women Undergoing in Vitro Fertilization-embryo Transfer (IVF-ET).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571801', 'term': 'follitropin alfa'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 248}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2025-04-02', 'studyFirstSubmitQcDate': '2025-04-08', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of oocytes retrieved', 'timeFrame': '36 ± 3 hours after HGC trigger'}], 'secondaryOutcomes': [{'measure': 'High quality embryo rate', 'timeFrame': '3 days after oocyte retrieval'}, {'measure': 'Biochemical pregnancy rate', 'timeFrame': '14 days after embryo transfer'}, {'measure': 'Clinical pregnancy rate', 'timeFrame': '5 weeks after embryo transfer'}, {'measure': 'Ongoing pregnancy rate', 'timeFrame': '10 weeks after embryo transfer'}, {'measure': 'Miscarriage rate', 'timeFrame': '28 weeks of gestation'}, {'measure': 'Live birth rate', 'timeFrame': '40 weeks of gestation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Female Infertility']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized, open-label, active-controlled, parallel-group, multicenter, phase IV study is to assess the efficacy and safety of Fang Le Shu versus Guo Na Fen used for controlled ovarian stimulation in infertile women undergoing In Vitro Fertilization-Embryo Transfer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Is pre-menopausal female aged ≥20 to \\<40 years.\n* Has regular menstrual cycles of ≥25 to ≤35 days.\n* Has Normal baseline serum FSH, LH, E2, P4.\n* Is able to voluntarily sign the informed consent form (ICF).\n* Has history of infertility for at least 1 year before the day of randomization; however, subjects with confirmed diagnosis of infertility are eligible without fulfilling the 1-year requirement.\n\nExclusion Criteria:\n\n* Has any known clinically significant major systemic disease, or endocrine or metabolic abnormalities with the exception of controlled thyroid function disease.\n* Has body mass index (BMI) of \\>30 kg/m2.\n* Has clinically significant abnormalities of the uterus, ovary, or appendix prior to the day of randomization\n* Has history of surgeries that may affect oocyte retrieval or pregnancy outcome, such as surgical resection of uterine mediastinum, fibroids, or cysts (however, patients who received polypectomy are allowed to enroll).\n* Has history of severe ovarian hyperstimulation syndrome (OHSS) defined as Grade 4 or higher.\n* Poor ovarian reponder according to Bologna criteria\n* Has plans to donate oocyte or recieve embryo from another women or undergo preimplantation genetic testing(PGT)\n* Has history of three or more failures in previous IVF cycles\n* Has history of recurrent miscarriage\n* Has known current active pelvic inflammatory disease.\n* Is currently breastfeeding.\n* Has a contraindication to pregnancy that would preclude participation in the trial.'}, 'identificationModule': {'nctId': 'NCT06921395', 'briefTitle': 'Phase IV Study to Evaluate the Efficacy and Safety of Fang Le Shu Compared to Guo Na Fen for Controlled Ovarian Stimulation in Infertile Women Undergoing in Vitro Fertilization-embryo Transfer (IVF-ET).', 'organization': {'class': 'INDUSTRY', 'fullName': 'LG Chem'}, 'officialTitle': 'A Phase IV, Prospective, Randomized, Open-label, Active-controlled, Parallel-group, Multicenter Study to Evaluate Efficacy and Safety of Fang Le Shu (Recombinant FSH) Versus Guo Na Fen Used for Controlled Ovarian Stimulation in Infertile Women Undergoing In Vitro Fertilization-Embryo Transfer.', 'orgStudyIdInfo': {'id': 'LG-FSCL006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fang Le Shu', 'description': 'Fang Le Shu', 'interventionNames': ['Drug: Fang Le Shu (Follitrope)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Guo Na Fen', 'description': 'Guo Na Fen', 'interventionNames': ['Drug: Guo Na Fen (Gonal-F)']}], 'interventions': [{'name': 'Fang Le Shu (Follitrope)', 'type': 'DRUG', 'description': 'rFSH 150 IU, 225 IU, 300 IU per syringe', 'armGroupLabels': ['Fang Le Shu']}, {'name': 'Guo Na Fen (Gonal-F)', 'type': 'DRUG', 'description': 'rFSH 450 IU per pen', 'armGroupLabels': ['Guo Na Fen']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhengzhou', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The first affiliated hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Clinical Study Lead', 'role': 'CONTACT', 'email': 'lgclinical@lgchem.com', 'phone': '+82-2-6987-4147'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LG Chem', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}