Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-27 @ 9:59 PM
Study NCT ID:
NCT06098495
Status:
RECRUITING
Last Update Posted:
2023-10-24
First Post:
2023-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Looking for a Blood Epigenetic Signature to Predict Female Infertility
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood sample, Oocyte granulosa cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1456}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2026-10-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-18', 'studyFirstSubmitDate': '2023-10-18', 'studyFirstSubmitQcDate': '2023-10-18', 'lastUpdatePostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'differences of DNA methylation in granulosa cells of patients undergoing ART', 'timeFrame': '3 years', 'description': "The epigenetic profile of DNA extracted from granulosa cells of patients undergoing ART (COHORT1) will be examined to identify position and region's differences of DNA methylation in pregnant women (fertile women) and in who does not get pregnant (infertile women)"}, {'measure': 'differences of DNA methylationin the peripheral venous blood of patients undergoing ART', 'timeFrame': '3 years', 'description': 'search for this methylation difference found in the granulosa cell sample, also in the peripheral venous blood of these same patients'}, {'measure': 'differences of DNA methylationin the peripheral venous blood of women attempting to conceive naturally', 'timeFrame': '3 years', 'description': 'The specific epigenetic modification will be searched in the peripheral venous blood of women attempting to conceive naturally (COHORT2)'}, {'measure': 'differences of DNA methylationin the peripheral venous blood of new patients undergoing ART', 'timeFrame': '3 years', 'description': 'The specific epigenetic modification will be searched in the peripheral venous blood of two new cohorts of patients referred to PMA centres.'}, {'measure': 'impact of exogenous pro-inflammatory factors', 'timeFrame': '3 years', 'description': 'on all the above cohorts will be investigated, via online questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Female Infertility']}, 'descriptionModule': {'briefSummary': 'The present research project aims to study the DNAm mechanisms underlying the reduction of fertility due to the progressive depletion of oocyte quality. Specifically, our project aims to build an epigenetic clock for MGCs by using outcomes that are certainly related to female fertility. The validation of such findings will be carried out on peripheral blood in order to guarantee its non-invasiveness and allow for any clinical transferability. In order to identify a blood epigenetic signature able to predict female infertility, we planned to explore the problem from different points of view by conducting several studies in different settings.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infertile woman undergoing ART, women affected by recurrent pregnancy loss, women attempting to conceive naturally', 'genderDescription': 'female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18\\< age \\<43, Infertile woman undergoing ART, recurrent pregnancy loss\n\nExclusion Criteria:\n\n* age \\< 18 or \\> 44, previous ovarian surgery, severe male factor infertility'}, 'identificationModule': {'nctId': 'NCT06098495', 'acronym': 'FIB_CARIPLO', 'briefTitle': 'Looking for a Blood Epigenetic Signature to Predict Female Infertility', 'organization': {'class': 'OTHER', 'fullName': 'Università Vita-Salute San Raffaele'}, 'officialTitle': 'Looking for a Blood Epigenetic Signature to Predict Female Infertility', 'orgStudyIdInfo': {'id': 'FIB_CARIPLO_1.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'infertile women (unexplained, tubal, mild male factor)', 'description': 'women belonging to couples selected for homologous IVF due to an unexplained, tubal or mild male factor'}, {'label': 'fertile women', 'description': 'women without any infertility history who are attempting to conceive naturally', 'interventionNames': ['Genetic: search for epigenetic profile of infertility']}, {'label': 'infertile women (ovarian factor)', 'description': 'women selected for homologous IVF for different reason og chohort 1', 'interventionNames': ['Genetic: search for epigenetic profile of infertility']}, {'label': 'recurrent pregnancy loss', 'description': 'women affected by idiopathic recurrent pregnancy loss', 'interventionNames': ['Genetic: search for epigenetic profile of infertility']}], 'interventions': [{'name': 'search for epigenetic profile of infertility', 'type': 'GENETIC', 'description': 'examine the epigenetic profile of DNA extracted from MGCs and blood sample', 'armGroupLabels': ['fertile women', 'infertile women (ovarian factor)', 'recurrent pregnancy loss']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Valeria Stella Vanni', 'role': 'CONTACT', 'email': 'vanni.valeria@hsr.it', 'phone': '+393476309895'}, {'name': "Sara D'Alessandro", 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Università Vita Salute San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Valeria Stella Vanni', 'role': 'CONTACT', 'email': 'vanni.valeria@hsr.it', 'phone': '+393476309895'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'publication of the results at the end of the trial'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università Vita-Salute San Raffaele', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Valeria Stella Vanni', 'investigatorAffiliation': 'Università Vita-Salute San Raffaele'}}}}