Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-20 @ 12:01 PM
Study NCT ID:
NCT02482467
Status:
TERMINATED
Last Update Posted:
2025-05-16
First Post:
2015-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognosis and Long Term Pubertal Outcome of Girls Previously Diagnosed With a Prenatal Ovarian Cyst
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010048', 'term': 'Ovarian Cysts'}], 'ancestors': [{'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'whyStopped': 'No difference between groups after analysis', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2015-06-15', 'studyFirstSubmitQcDate': '2015-06-23', 'lastUpdatePostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Age of puberty', 'timeFrame': '1 day', 'description': 'Clinical data and clinical history'}], 'secondaryOutcomes': [{'measure': 'Follicular reserve', 'timeFrame': '1 day', 'description': 'Serum level of Anti-Mullerian Hormone and ovarian volume at ultrasonography'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ovarian cyst', 'prenatal diagnosis', 'puberty'], 'conditions': ['Ovarian Cyst']}, 'descriptionModule': {'briefSummary': 'Puberty and long-term ovarian function of patients with a ovarian prenatal cyst has not described to date.', 'detailedDescription': 'The prenatal diagnosis of ovarian cysts is a common disease with an estimated incidence of 1 case per 2500 births. This pathology is the first diagnosis of abdominal cystic picture on the female fetus in the third trimester of pregnancy.Various complications of ovarian cysts have been described, such as ovarian torsion, breaking the cyst, hemorrhage intra cystic and compression of adjacent viscera. A conservative attitude for uncomplicated cysts is proposed in the literature but surgical care and / or puncture can be made to prevent the occurrence of complications and thus to protect ovarian tissue.However, no data on puberty and long-term ovarian prognosis in this disease is published in the literature. Without this information, no support for the recommendation of a prenatal ovarian cyst can be established formally.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '24 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Collection of the written consent by the patients or the parents\n* Membership in a health insurance scheme\n* Group 1 : girl with prenatal ovarian cyst group 2: girl without prenatal ovarian cyst\n\nExclusion Criteria:\n\n* Refusal of participation of the patient or one of the two parents\n* Deprived of freedom\n* Pregnancy and current feeding\n* Prenatal, neonatal or infantile history of ovarian pathology (Group 2)\n* Genital congenital deformation or malformation syndrome gives a complex (group 2)\n* Endocrine pathology except the juvenile disorders (group 2)'}, 'identificationModule': {'nctId': 'NCT02482467', 'acronym': 'KYSTOV', 'briefTitle': 'Prognosis and Long Term Pubertal Outcome of Girls Previously Diagnosed With a Prenatal Ovarian Cyst', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Prognosis and Long Term Pubertal Outcome of Girls Previously Diagnosed With a Prenatal Ovarian Cyst', 'orgStudyIdInfo': {'id': '9434'}, 'secondaryIdInfos': [{'id': '2014-A01025-42', 'type': 'REGISTRY', 'domain': 'ID RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cases', 'description': 'Prenatal diagnosis of ovarian cyst', 'interventionNames': ['Other: Hormonal analysis, pelvic US']}, {'type': 'OTHER', 'label': 'controls', 'description': 'No prenatal diagnosis of cyst', 'interventionNames': ['Other: Hormonal analysis, pelvic US']}], 'interventions': [{'name': 'Hormonal analysis, pelvic US', 'type': 'OTHER', 'armGroupLabels': ['Cases', 'controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hôpital Lapeyronie', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Nicolas KALFA, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montpellier University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}