Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-29 @ 7:29 PM
Study NCT ID:
NCT05667428
Status:
UNKNOWN
Last Update Posted:
2023-02-23
First Post:
2022-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter Open-label Clinical Study on the Prevention of Premature Ovarian Failure After HSCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016649', 'term': 'Primary Ovarian Insufficiency'}], 'ancestors': [{'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'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': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016729', 'term': 'Leuprolide'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-22', 'studyFirstSubmitDate': '2022-10-27', 'studyFirstSubmitQcDate': '2022-12-26', 'lastUpdatePostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'POF rate', 'timeFrame': 'three years after transplantation', 'description': 'Incidence of premature ovarian failure after transplantation'}], 'secondaryOutcomes': [{'measure': 'acute GVHD rate', 'timeFrame': 'At day 100 post-transplantation', 'description': 'the incidence of acute graft-versus-host disease (GVHD)'}, {'measure': 'chronic GVHD rate', 'timeFrame': 'From date of HSCT until the end of follow-up or the date of death from any cause, whichever came first,assessed up to 36 months.', 'description': 'the incidence of chronic graft-versus-host disease (GVHD)'}, {'measure': 'PFS', 'timeFrame': 'From date of HSCT until the end of follow-up or the date of death from any cause, whichever came first，assessed up to 36 months.', 'description': 'Progression Free Survival'}, {'measure': 'OS', 'timeFrame': 'From date of diagnosis until the end of follow-up or the date of death from any cause, whichever came first，assessed up to 36 months.', 'description': 'Overall Survival'}, {'measure': 'AEs', 'timeFrame': 'up to 6 months after HSCT', 'description': 'Adverse reations include abnormalities in bone mineral density, blood glucose, liver and kidney functions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematopoietic Stem Cell Transplantation', 'Premature Ovarian Failure']}, 'descriptionModule': {'briefSummary': 'HSCT is an effective method to cure hematologic malignancies. However, the reproductive system is prone to be damaged during radiotherapy and chemotherapy before transplantation, leading to ovarian failure, followed by infertility and premature ovarian failure (POF), which seriously affect the long-term quality of life of patients. This clinical trial aimed to observe the effect of Gonadotropin-releasing hormone analogues (GnRHa) on ovarian function in women of reproductive age after HSCT, so as to provide clinical evidence for whether GnRHa should be used for the prevention of POF.', 'detailedDescription': 'Hematopoietic stem cell transplantation (HSCT) is an effective method for the treatment of hematologic malignancies. However, in the process of radiotherapy and chemotherapy before transplantation, the reproductive system is vulnerable to damage, leading to ovarian failure, which leads to infertility and premature ovarian failure (POF), seriously affecting the long-term quality of life of patients. Exogenous injection of gonadotropin-releasing hormone analogue (GnRHa) has a significant effect on fertility preservation in adolescent and reproductive female patients with breast cancer and cervical cancer. However, there is a lack of large-scale clinical studies on POF in HSCT. Therefore, this clinical trial aimed to observe the effect of GnRHa application before transplantation on ovarian function in women of reproductive age after transplantation, so as to provide clinical evidence for whether GnRHa application for fertility function protection.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with acute leukemia, MDS, lymphoma, multiple myeloma, SAA and other hematological diseases, with the indications for autologous or allogeneic hematopoietic stem cell transplantation.\n* Female, aged 18-45 years.\n* Ovarian function was normal before treatment.\n* Volunteer to participate in clinical research and sign the informed consent form.\n\nExclusion Criteria:\n\n* No menstruation before treatment, undergone hysterectomy or ovarian surgery.\n* Abnormal sexual development.\n* Received radiotherapy.\n* Combined with tumors affecting gonadal function.\n* Deep vein thrombosis.\n* Hypertension, liver and/or kidney dysfunction cannot tolerate hematopoietic stem cell transplantation.'}, 'identificationModule': {'nctId': 'NCT05667428', 'briefTitle': 'A Multicenter Open-label Clinical Study on the Prevention of Premature Ovarian Failure After HSCT', 'organization': {'class': 'OTHER', 'fullName': "First Affiliated Hospital Xi'an Jiaotong University"}, 'officialTitle': 'A Multicenter Open-label Clinical Study on the Prevention of Premature Ovarian Failure After Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'XJTU1AF-CRF-2022-XK002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Leprorelin group', 'description': 'Leprorelin was given subcutaneously before each cycle of chemotherapy.', 'interventionNames': ['Drug: leuprorelin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Normal salinewas given subcutaneously before each cycle of chemotherapy.', 'interventionNames': ['Drug: normal saline']}], 'interventions': [{'name': 'leuprorelin', 'type': 'DRUG', 'otherNames': ['GnRHa'], 'description': 'From the initial chemotherapy after diagnosis, patients received a subcutaneous injection of leprorelin in each cycle of chemotherapy including the conditioning treatment prior to transplantation.', 'armGroupLabels': ['Leprorelin group']}, {'name': 'normal saline', 'type': 'DRUG', 'otherNames': ['NS'], 'description': 'From the initial chemotherapy after diagnosis, patients received a subcutaneous injection of normal saline in each cycle of chemotherapy including the conditioning treatment prior to transplantation.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'First Affiliated Hospital of Xian Jiaotong University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Xiaoning Wang, MD', 'role': 'CONTACT', 'email': 'wangxn99@163.com', 'phone': '0086-18991232608'}, {'name': 'Xiaoyan Zheng, MD', 'role': 'CONTACT', 'email': 'xiaoy_2008@126.com', 'phone': '0086-15829370502'}], 'overallOfficials': [{'name': 'Xiaoning Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "First Affiliated Hospital Xi'an Jiaotong University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}