Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2026-03-01 @ 5:00 PM
Study NCT ID:
NCT02184806
Status:
UNKNOWN
Last Update Posted:
2017-11-06
First Post:
2014-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autograft of Human Ovarian Tissue : Efficiency and Safety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-03', 'studyFirstSubmitDate': '2014-06-13', 'studyFirstSubmitQcDate': '2014-07-03', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biological (FSH, LH, E2 and AMH) changes from graft until the revovery of ovarian function', 'timeFrame': 'every month after graft, up to 18 months', 'description': 'FSH, LH, E2 and AMH follow up every month after graft until the recovery of ovarian function, up to 18 months'}, {'measure': 'Radiological (ultrasonography and MRI) changes in ovarian imaging from graft until the revovery of ovarian function', 'timeFrame': 'every month after graft, up to 18 months', 'description': 'Radiological (only ultrasonography the first 3 months and after ultrasonography and MRI) follow up every month after graft until the recovery of ovarian function, up to 18 months'}], 'secondaryOutcomes': [{'measure': 'Graft vascularization', 'timeFrame': 'every month up to 18 months'}, {'measure': 'Relapse of the pathology', 'timeFrame': 'every month up to 18 months'}, {'measure': 'Delay and quality of the ovarian function recovery between ortho and heterotopic graft', 'timeFrame': 'after ovarian function recovery, up to 18 months'}, {'measure': 'Number of ovarian fragments necessary for ovarian function recovery', 'timeFrame': 'up to 18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ovarian tissue transplantation', 'Cryopreserved ovarian tissue'], 'conditions': ['Ovarian Tissue Transplantation']}, 'referencesModule': {'references': [{'pmid': '33389379', 'type': 'DERIVED', 'citation': 'Vatel M, Torre A, Paillusson B, Scheffler F, Bergere M, Benkhalifa M, Le Martelot MT, Leperlier F, Mirallie S, Selleret L, Prades-Borio M, Neuraz A, Barraud-Lange V, Boissel N, Fortin A, Poirot C. Efficacy of assisted reproductive technology after ovarian tissue transplantation in a cohort of 11 patients with or without associated infertility factors. J Assist Reprod Genet. 2021 Feb;38(2):503-511. doi: 10.1007/s10815-020-02033-9. Epub 2021 Jan 3.'}, {'pmid': '31116405', 'type': 'DERIVED', 'citation': 'Poirot C, Fortin A, Lacorte JM, Akakpo JP, Genestie C, Vernant JP, Brice P, Morice P, Leblanc T, Gabarre J, Delmer A, Badachi Y, Drouineaud V, Gouy S, Chalas C, Egels S, Dhedin N, Touraine P, Dommergues M, Lebegue G, Wolf JP, Capron F, Lefebvre G, Boissel N; CAROLeLISA Cooperative Group. Impact of cancer chemotherapy before ovarian cortex cryopreservation on ovarian tissue transplantation. Hum Reprod. 2019 Jun 4;34(6):1083-1094. doi: 10.1093/humrep/dez047.'}]}, 'descriptionModule': {'briefSummary': 'Ovarian tissue cryopreservation is a new technique for female fertility preservation. One way to restore fertility is autotransplantation of ovarian tissue.\n\nThe principal purpose of this study will be to evaluate the efficiency and safety of this procedure.', 'detailedDescription': 'Ovarian tissue cryopreservation is a new technique for female fertility preservation before gonadotoxic treatments. The first ovarian tissue cryopreservations were performed 10 years ago. There are two main methods to use frozen ovarian cortex: autograft of ovarian fragments and in vitro follicular growth. At the present time, none mature oocytes were obtained after culture. Since 2000, around twenty publications stating autografts of ovarian cortex reported 8 pregnancy and 6 life birth of healthy babies.\n\nSince 1998 until 2008, in the unit of reproduction biology of pitie-salpetriere hospital in Paris, France, 330 patients have had an ovarian tissue cryopreservation for fertility preservation before gonadotoxic treatment. Among them, at the present time, 180 have a procreative age and in consequence, could ask for the use of their ovarian cortex.\n\nThe general aim of this protocol will be to propose to women wishing to have a baby, an ovarian tissue transplantation if the patients have an premature ovarian failure.\n\nThe principal aim of this study will be to evaluate the efficiency and the safety of ovarian transplantation.\n\nBefore grafting, the absence of contra- indication will be check. An informed consent will be signed by the patient. Autograft of ovarian cortex will be performed either in orthotopic or in heterotopic localization according to the pathology and a possible contra-indication to orthotopic position.\n\nAfter graft, each month hormonal assessment, ovarian echography and, after 3 months, an MRI, will be performed.\n\nAssisted Reproductive Technologies (ART) will be performed in case of heterotopic graft and if necessary in case of orthotopic graft.\n\nThe efficiency of ovarian tissue autograft will be appreciated by the delay before the recovery of the ovarian function, the oocyte and embryos qualities in case of ART.\n\nFinally, the number of pregnancies and live births will be also appreciated as well as a possible recurrence of the pathology.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria :\n\n* adult women (age ≥ 18 years old) who stored ovarian fragments before gonadotoxic treatments\n* Women who desire to conceive\n* Married women or in stable couple\n* Cured women or in remission\n* Women suffering of Premature ovarian failure\n* Consenting women\n* women with health insurance\n\nExclusion criteria :\n\n* age \\< 18 years\n* women with normal ovarian function\n* women with a disease at high risk for ovarian metastasis\n* women with contraindication for surgery\n* women with contraindication for pregnancy\n* not cured women or not in remission\n* women without health insurance'}, 'identificationModule': {'nctId': 'NCT02184806', 'acronym': 'CAROLéLISA', 'briefTitle': 'Autograft of Human Ovarian Tissue : Efficiency and Safety', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Autograft of Human Ovarian Tissue: Efficiency and Safety Evaluation', 'orgStudyIdInfo': {'id': 'P080802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1- orthotopic graft', 'interventionNames': ['Procedure: orthotopic graft']}, {'type': 'EXPERIMENTAL', 'label': '2- heterotopic graft', 'interventionNames': ['Procedure: heterotopic graft']}], 'interventions': [{'name': 'orthotopic graft', 'type': 'PROCEDURE', 'otherNames': ['ovarian tissue autotransplantation'], 'description': '(1) laparoscopy (2) ovarian fragments can be put back inside the pelvic cavity close to the natural location of the ovaries or', 'armGroupLabels': ['1- orthotopic graft']}, {'name': 'heterotopic graft', 'type': 'PROCEDURE', 'description': '1. put under the skin\n2. the ovarian fragments can be put under the skin of the abdomen', 'armGroupLabels': ['2- heterotopic graft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75020', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Poirot Catherine, MD, PhD', 'role': 'CONTACT', 'email': 'Catherine.poirot@tnn.aphp.fr', 'phone': '+33 1 56 01 78 00'}], 'facility': 'Hôpital Tenon, service de Biologie de la reproduction', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Poirot Catherine, MD, PhD', 'role': 'CONTACT', 'email': 'Catherine.poirot@tnn.aphp.fr', 'phone': '+33 1 56 01 78 00'}], 'overallOfficials': [{'name': 'Poirot Catherine, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agence de La Biomédecine', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}