Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:13 PM
Study NCT ID:
NCT06261658
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2024-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improving the Quality of Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'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': 'D007246', 'term': 'Infertility'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2033-12-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-08', 'studyFirstSubmitDate': '2024-02-08', 'studyFirstSubmitQcDate': '2024-02-08', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma', 'timeFrame': 'first year', 'description': 'to evaluate the safety of intraovarian PRP injection in terms of absence of adverse reactions to laparoscopic ovarian tissue reimplantation surgery. Patients in early menopause or with irregular menstrual cycles who have cryopreserved their ovarian tissue at the Cryobank of Division of Gynaecology and Human Reproduction Physiopathology, IRCCS Azienda Ospedaliero-Universitaria di Bologna will be recruited. These patients will be joined by a historical cohort of patients who have the inclusion criteria of this study and who have already undergone reimplantation of ovarian tissue as the routine clinical care procedure.'}], 'secondaryOutcomes': [{'measure': 'Effectiveness of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma', 'timeFrame': '9 years', 'description': 'to evaluate whether the use of autologous PRP during the ovarian tissue transplantation leads to an improvement of outcomes in terms of ovarian function recovery (endocrine and reproductive functions). Patients in early menopause or with irregular menstrual cycles who have cryopreserved their ovarian tissue at the Cryobank of Division of Gynaecology and Human Reproduction Physiopathology, IRCCS Azienda Ospedaliero-Universitaria di Bologna will be recruited. These patients will be joined by a historical cohort of patients who have the inclusion criteria of this study and who have already undergone reimplantation of ovarian tissue as the routine clinical care procedure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cryopreserved Ovarian Tissue', 'Ovarian tissue transplantation', 'Platelet-enriched Autologous Plasma', 'ovarian endocrine function', 'livebirths'], 'conditions': ['Cryopreservation', 'Ovary Injury', 'Infertility, Female', 'Menopause Ovarian Failure']}, 'referencesModule': {'references': [{'pmid': '32700285', 'type': 'BACKGROUND', 'citation': 'Petryk N, Petryk M. Ovarian Rejuvenation Through Platelet-Rich Autologous Plasma (PRP)-a Chance to Have a Baby Without Donor Eggs, Improving the Life Quality of Women Suffering from Early Menopause Without Synthetic Hormonal Treatment. Reprod Sci. 2020 Nov;27(11):1975-1982. doi: 10.1007/s43032-020-00266-8. Epub 2020 Jul 22.'}, {'pmid': '29564738', 'type': 'BACKGROUND', 'citation': 'Bos-Mikich A, de Oliveira R, Frantz N. Platelet-rich plasma therapy and reproductive medicine. J Assist Reprod Genet. 2018 May;35(5):753-756. doi: 10.1007/s10815-018-1159-8. Epub 2018 Mar 21.'}, {'pmid': '33886116', 'type': 'BACKGROUND', 'citation': 'Mouanness M, Ali-Bynom S, Jackman J, Seckin S, Merhi Z. Use of Intra-uterine Injection of Platelet-rich Plasma (PRP) for Endometrial Receptivity and Thickness: a Literature Review of the Mechanisms of Action. Reprod Sci. 2021 Jun;28(6):1659-1670. doi: 10.1007/s43032-021-00579-2. Epub 2021 Apr 22.'}, {'pmid': '33723748', 'type': 'BACKGROUND', 'citation': 'Sharara FI, Lelea LL, Rahman S, Klebanoff JS, Moawad GN. A narrative review of platelet-rich plasma (PRP) in reproductive medicine. J Assist Reprod Genet. 2021 May;38(5):1003-1012. doi: 10.1007/s10815-021-02146-9. Epub 2021 Mar 15.'}, {'pmid': '35175511', 'type': 'BACKGROUND', 'citation': 'Seckin S, Ramadan H, Mouanness M, Kohansieh M, Merhi Z. Ovarian response to intraovarian platelet-rich plasma (PRP) administration: hypotheses and potential mechanisms of action. J Assist Reprod Genet. 2022 Jan;39(1):37-61. doi: 10.1007/s10815-021-02385-w. Epub 2022 Feb 17.'}]}, 'descriptionModule': {'briefSummary': 'The study is aimed to evaluate the effects of intraovarian injection of autologous Platelet-enriched Autologous Plasma on the outcomes of orthotopic transplantation of cryopreserved ovarian tissue.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* request for cryopreserved ovarian tissue transplantation;\n* premature ovarian failure or irregular mentrual cycles;\n* negative test for HIV, HBV, HCV, Treponema pallidum;\n* negative PAP test;\n* oncological authorization;\n* absence of neoplastic contamination in the cryopreserved ovarian tissue;\n* Informed consent\n\nExclusion Criteria:\n\n* neoplastic contamination in cryopreserved ovarian tissue;\n* history of endometriosis;\n* endocrinological disorders present and not treated (uncompensated thyroid dysfunction, diabetes (type 1, type 2);\n* body mass index (BMI) \\>30 kg/m2;\n* circulating platelet level \\< 150,000 / mml;\n* bacterial infection;\n* ongoing use of anticoagulants;\n* bleeding diathesis.'}, 'identificationModule': {'nctId': 'NCT06261658', 'acronym': 'TESOVA2022', 'briefTitle': 'Improving the Quality of Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}, 'officialTitle': 'Improving the Quality of Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma', 'orgStudyIdInfo': {'id': 'TESOVA2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma', 'interventionNames': ['Procedure: Cryopreserved Ovarian Tissue Reimplantation']}], 'interventions': [{'name': 'Cryopreserved Ovarian Tissue Reimplantation', 'type': 'PROCEDURE', 'description': 'Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'BO', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Diego Raimondo, MD', 'role': 'CONTACT', 'email': 'die.raimondo@gmail.com', 'phone': '0512144389', 'phoneExt': '0039'}, {'name': 'Renato Seracchioli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Diego Raimondo, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rossella Vicenti, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Valentina Magnani, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Diego Raimondo', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Diego Raimondo, MD', 'role': 'CONTACT', 'email': 'die.raimondo@gmail.com', 'phone': '0512143732'}], 'overallOfficials': [{'name': 'Diego Raimondo, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'IRCCS AOU Bologna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Renato Seracchioli', 'investigatorAffiliation': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna'}}}}