Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:31 PM
Study NCT ID:
NCT07312058
Status:
RECRUITING
Last Update Posted:
2026-01-16
First Post:
2025-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Evaluation of Fertility Preservation Options in Women in Cancer Remission or Haematological Pathology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-15', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-12-16', 'lastUpdatePostDateStruct': {'date': '2026-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of an identifiable reproductive outcome', 'timeFrame': '1 year', 'description': 'Identifiable reproductive outcome are Spontaneous pregnancy, Use of preserved gametes or ovarian tissue (whether or not resulting in pregnancy), Use of donor oocytes, Discontinuation of the parenthood project'}], 'secondaryOutcomes': [{'measure': 'Type of fertility preservation method performed', 'timeFrame': '1 year'}, {'measure': 'Time interval (in months) between diagnosis and fertility preservation', 'timeFrame': '1 year'}, {'measure': 'Correlation between Age and occurance of an identifiable reproductive outcome', 'timeFrame': '1 year', 'description': 'Identifiable reproductive outcome are Spontaneous pregnancy, Use of preserved gametes or ovarian tissue (whether or not resulting in pregnancy), Use of donor oocytes, Discontinuation of the parenthood project'}, {'measure': 'Time interval (in months) between fertility preservation and initiation of potentially gonadotoxic treatment', 'timeFrame': '1 year'}, {'measure': 'Number of type of cancer associated with identifiable reproductive outcome', 'timeFrame': '1 year', 'description': 'Identifiable reproductive outcome are Spontaneous pregnancy, Use of preserved gametes or ovarian tissue (whether or not resulting in pregnancy), Use of donor oocytes, Discontinuation of the parenthood project'}, {'measure': 'Correlation between type of treatment and occurence of an identifiable reproductive outcome', 'timeFrame': '1 year', 'description': 'Identifiable reproductive outcome are Spontaneous pregnancy, Use of preserved gametes or ovarian tissue (whether or not resulting in pregnancy), Use of donor oocytes, Discontinuation of the parenthood project'}, {'measure': 'Correlation between family status and occurence of an identifiable reproductive outcome', 'timeFrame': '1 year', 'description': 'Identifiable reproductive outcome are Spontaneous pregnancy, Use of preserved gametes or ovarian tissue (whether or not resulting in pregnancy), Use of donor oocytes, Discontinuation of the parenthood project'}, {'measure': 'Time interval (in months) between completion of treatment and pregnancy attempt (spontaneous or medically assisted)', 'timeFrame': '1 year'}, {'measure': 'Actual utilization rate of preserved material', 'timeFrame': '1 year'}, {'measure': 'Success rate of reuse attempts', 'timeFrame': '1 year'}, {'measure': 'Proportion of patients who ultimately did not pursue parenthood', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fertility preservation', 'Cancer remission', 'Reproductive outcomes', 'Reproductive health', 'Oncology', 'Fertility counseling', 'Assisted reproductive technology', 'Psychological impact', 'Fertility observatory', 'Patient follow-up', 'Female cancer survivors', 'Fertility preservation techniques', 'Live birth rate'], 'conditions': ['Fertility Preservation', 'Cancer Remission', 'Reproductive Outcomes', 'Reproductive Health', 'Oncology', 'Fertility Counseling', 'Assisted Reproductive Technology', 'Psychological Impact', 'Fertility Observatory', 'Patient Follow-up', 'Female Cancer Survivors', 'Fertility Preservation Techniques', 'Live Birth Rate']}, 'descriptionModule': {'briefSummary': 'Cancer treatments, despite their increasing effectiveness, carry a significant risk of gamete toxicity.\n\nWomen of reproductive age are commonly offered fertility preservation (FP) before starting their treatment.\n\nHowever, few studies have analyzed the long-term reproductive outcomes of these interventions, nor how patients ultimately use or do not use the FP options once in remission.\n\nThis project aims to better understand the effectiveness, utilization, and psychological impacts of these strategies.\n\nThis work is part of an effort to understand and evaluate fertility preservation practices implemented for women of reproductive age undergoing cancer treatment at the Amiens-Picardie University Hospital (CHU).\n\nIts objective is to document patient pathways, clinical decisions, techniques employed, and reproductive outcomes observed after remission, in order to identify potential areas for improvement in the support and follow-up of these patients, thereby enhancing the overall quality and coordination of care.\n\nThis work is conducted alongside the development of a fertility observatory at the Department of Medicine and Reproductive Biology, CHU Amiens-Picardie.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '47 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients are recruited during follow-up consultations as part of the establishment of a fertility observatory within the Department of Medicine and Reproductive Biology at CHU Amiens Picardie', 'genderDescription': '* Women\n* Aged between 18 and 47 years\n* Diagnosed with cancer or hematological disorders requiring potentially gonadotoxic treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women\n* Aged between 18 and 47 years\n* Diagnosed with cancer or hematological disorders requiring potentially gonadotoxic treatment\n* Having undergone a medical fertility preservation consultation\n* Followed at Amiens Picardie University Hospital (CHU Amiens Picardie) in the department of Reproductive Medicine\n* Currently in remission\n* Having expressed non-opposition to participation in the study\n\nExclusion Criteria:\n\n* Absence of remission\n* Patients deprived of liberty by administrative or judicial decision, or placed under legal protection (guardianship or curators)\n* Decline to participate in the study'}, 'identificationModule': {'nctId': 'NCT07312058', 'acronym': 'FERT-ISSUES', 'briefTitle': 'Long-term Evaluation of Fertility Preservation Options in Women in Cancer Remission or Haematological Pathology', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Long-term Evaluation of Fertility Preservation Options in Women in Cancer Remission or Haematological Pathology', 'orgStudyIdInfo': {'id': 'PI2025_843_0156'}}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rosalie Cabry, Pr', 'role': 'CONTACT', 'email': 'Cabry.Rosalie@chu-amiens.fr'}], 'facility': 'CHU Amiens Picardie', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'CABRY-GOUBET Rosalie, Pr', 'role': 'CONTACT', 'email': 'cabry.rosalie@chu-amiens.fr', 'phone': '33+3 22 08 80 00'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}