Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-02-19 @ 6:42 PM
Study NCT ID:
NCT06505057
Status:
RECRUITING
Last Update Posted:
2024-08-14
First Post:
2024-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ovarian Tissue Cryopreservation and Subsequent Auto-Transplantation for Female Cancer Patients (HKCH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2041-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2024-07-11', 'studyFirstSubmitQcDate': '2024-07-11', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2039-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical complications', 'timeFrame': '15 years', 'description': 'Surgical complications after ovarian tissue transplantation'}], 'secondaryOutcomes': [{'measure': 'Pregnancy rate', 'timeFrame': '15 years', 'description': 'Pregnancy rate after ovarian tissue transplantation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neoplasms']}, 'descriptionModule': {'briefSummary': 'Ovarian tissue freezing is an ideal option for these patients as it can be performed immediately and does not need any time for ovarian stimulation. We hope we can develop this service in our locality to allow more young female cancer patients to have their fertility preserved.', 'detailedDescription': "To date, transplantation of cryopreserved ovarian tissue has resulted in births of at least 130 children but data on transplantation of ovarian tissue removed before puberty are scarce.\n\nDuring ovarian tissue cryopreservation (OTC), it is possible to freeze isolated oocytes. In 2003, Revel et al described for the first time oocyte isolation in children younger than 12 years with seven, eight and seven oocytes isolated from the ovarian cortex of patients aged 5, 8 and 10 years, respectively.\n\nAt this moment, financial constraint is another great hindrance to fertility preservation in Hong Kong as the procedure is not cheap. Cryopreservation of gametes and embryos involving assisted reproductive technology is expensive and the costs of fertility preservation impose a great burden to these cancer patients on top of the great expenses for their chemo- or radiotherapy. It is almost impossible for underprivileged families.\n\nYoung cancer patients may often need immediate gonadotoxic treatment for their cancer, just like those with haematological cancers. In these patients, egg or embryo freezing is not possible as it takes at least 8-12 days' time for ovarian stimulation. Ovarian tissue freezing is an ideal option for these patients as it can be performed immediately and does not need any time for ovarian stimulation. We hope we can develop this service in our locality to allow more young female cancer patients to have their fertility preserved."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged from 0-35 years old and diagnosed with cancer e.g., leukaemia, myeloproliferative or myelodysplastic diseases, lymphoma, bone tumours, neurological neoplasms and sarcoma, Paediatric bone marrow transplant patients\n* Patients with any illness or who will undergo any type of treatment that may cause irreversible damage to their fertility, such as extensive abdominal surgery, high toxicity medication and treatments;\n* Patients suffering from hormone-sensitive malignancies who will undergo medical treatment, such as radiotherapy and chemotherapy that is liable to damage their ovaries and deter them from conception in the future.\n\nExclusion Criteria:\n\nPatients with no anticipated oncologic therapies Patients who are pregnant Children with one ovary Children deemed high risk for perioperative complications Patients unable to provide consent/assent (i.e. significant psychiatric problems/cognitive delay)\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06505057', 'briefTitle': 'Ovarian Tissue Cryopreservation and Subsequent Auto-Transplantation for Female Cancer Patients (HKCH)', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Ovarian Tissue Cryopreservation and Subsequent Auto-Transplantation for Female', 'orgStudyIdInfo': {'id': 'PAED-2023-079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ovarian tissue freezing and subsequent auto-transplantation after thawing', 'description': 'Removal of the ovarian tissue will be retrieved via laparoscopic surgery under general anesthesia. The ovarian cortical tissue obtained will be transferred on ice to the laboratory for cryopreservation. After medical treatment, if the patient would like to start a family but has experienced premature ovarian failure, she will have ovarian tissue auto-transplantation after thawing.', 'interventionNames': ['Other: Ovarian Tissue Cryopreservation and Subsequent Auto-Transplantation']}], 'interventions': [{'name': 'Ovarian Tissue Cryopreservation and Subsequent Auto-Transplantation', 'type': 'OTHER', 'description': 'Ovarian Tissue Cryopreservation and Subsequent Auto-Transplantation', 'armGroupLabels': ['ovarian tissue freezing and subsequent auto-transplantation after thawing']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Elaine NG, MPhil', 'role': 'CONTACT', 'email': 'elaineng@cuhk.edu.hk', 'phone': '35052745'}, {'name': 'Jacqueline Pui Wah CHUNG, MBBS', 'role': 'CONTACT', 'email': 'acquelinechung@cuhk.edu.hk', 'phone': '35051537'}], 'facility': "Hong Kong Children's Hospital", 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Elaine NG, MPhil', 'role': 'CONTACT', 'email': 'elaineng@cuhk.edu.hk', 'phone': '35052745'}], 'overallOfficials': [{'name': 'Jacqueline Pui Wah CHUNG, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Chung Pui Wah Jacqueline', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}