{"doc_desc":{"title":"Registre national des tentatives de F\u00e9condation In Vitro","idno":"FRESH-PEF8378-fr","producers":[{"name":" Agence de la Biom\u00e9decine","affiliation":"AGENCE DE LA BIOMEDECINE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8378-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"8378"},{"agency":"FReSH","code":"FRESH-PEF8378"}]},"title":"Registre national des tentatives de F\u00e9condation In Vitro","alternate_title":"FIV-ABM"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Fabienne;PESSIONE","PILabo":"Agence de la \/ Direction Procr\u00e9ation Embryologie G\u00e9n\u00e9tique humaine","affiliationName":"AGENCE DE LA BIOMEDECINE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"077184408","role":"pi id"},{"title":"SIREN","uri":"180092587","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"fabienne.pessione@biomedecine.fr","isContact":"Oui"},{"type":"investigator","name":"Dominique;ROYERE","PILabo":"Agence de la \/ Direction Procr\u00e9ation Embryologie G\u00e9n\u00e9tique humaine","affiliationName":"AGENCE DE LA BIOMEDECINE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"059711361","role":"pi id"},{"title":"SIREN","uri":"180092587","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"dominique.royere@biomedecine.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"AGENCE DE LA BIOMEDECINE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/03tajza86","role":"sponsor id"},{"title":"SIREN","uri":"180092587","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"MINISTERE DU TRAVAIL, DE LA SANTE, DES SOLIDARITES ET DES FAMILLES","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01wp0c315"},{"title":"SIREN","uri":"130016546"}]}]},"distribution_statement":{"contact":[{"name":"Fabienne;PESSIONE","email":"fabienne.pessione@biomedecine.fr","type":"contact","affiliationName":"AGENCE DE LA BIOMEDECINE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/03tajza86","role":"organisation id","title":"ROR"},{"uri":"180092587","role":"organisation id","title":"SIREN"}]},{"name":"Dominique;ROYERE","email":"dominique.royere@biomedecine.fr","type":"contact","affiliationName":"AGENCE DE LA BIOMEDECINE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/03tajza86","role":"organisation id","title":"ROR"},{"uri":"180092587","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"F\u00e9condation in vitro"},{"keyword":"FIV"},{"keyword":"Assistance M\u00e9dicale \u00e0 la Procr\u00e9ation"},{"keyword":"AMP"},{"keyword":"f\u00e9condit\u00e9"},{"keyword":"infertilit\u00e9."},{"keyword":"registre"}],"topics":[{"topic":"Gyn\u00e9cologie et obst\u00e9trique","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7de64596-5b0d-4977-8f98-b982ff2ec17d"},{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/284ca20c-beb4-4abe-99fa-ef4513358bad"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D006176"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D009774"}]},{"topic":"Infertilit\u00e9 f\u00e9minine","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1237004558","title":"CIM-11"}]},{"topic":"Infertilit\u00e9 masculine","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/753457327","title":"CIM-11"}]},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Les objectifs de ce registre sont de d\u00e9crire de fa\u00e7on exhaustive les activit\u00e9s de F\u00e9condation In Vitro en France (rapport annuel d\u2019activit\u00e9 de l\u2019Agence, analyses r\u00e9gionales\u2026), d\u2019\u00e9valuer les r\u00e9sultats en prenant en compte l\u2019ensemble des facteurs li\u00e9s: - \u00e0 la femme (\u00e2ge consommation de tabac, indication de l\u2019inf\u00e9condit\u00e9,\u2026) - \u00e0 l\u2019homme (consommation de tabac, indication de l\u2019inf\u00e9condit\u00e9,\u2026) - \u00e0 la tentative elle-m\u00eame (rang de la tentative, origine des gam\u00e8tes, technique utilis\u00e9e, qualit\u00e9 des embryons\u2026) Il permettra de conna\u00eetre le parcours de soins suivi par un couple donn\u00e9, sur plusieurs ann\u00e9es, tentatives par tentatives, dans diff\u00e9rents centres si n\u00e9cessaire et de proposer des recommandations en vue de l\u2019am\u00e9lioration de la pratique clinique pour le b\u00e9n\u00e9fice du patient. De suivre les grossesses et d'\u00e9tudier l'issue des accouchements afin d'\u00e9valuer la sant\u00e9 des enfants \u00e0 la naissance.","abstract":"","coll_dates":[{"start":"2008-01-01","end":"2012-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" les tentatives de FIV (avec ou sans ICSI) et les transferts d'embryons congel\u00e9s  - pas d'inclusion des ins\u00e9mination intra-ut\u00e9rines, ni des stimulation ovariennes simples.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Un plan de validation des donn\u00e9es listant tous les contr\u00f4les de qualit\u00e9 \u00e0 appliquer sur les donn\u00e9es de chaque rapport d\u2019activit\u00e9 re\u00e7u est d\u00e9fini chaque ann\u00e9e. Ce plan vise \u00e0 d\u00e9finir les contr\u00f4les permettant d\u2019identifier les donn\u00e9es manquantes ou incoh\u00e9rentes. Une demande de clarification des donn\u00e9es est syst\u00e9matiquement adress\u00e9e aux centres afin qu\u2019ils puissent corriger ou expliquer leurs donn\u00e9es manquantes ou incoh\u00e9rentes.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nConsommation de soins\/services de sant\u00e9\r\nAutres"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s libre","sources":[],"target_sample_size":">= 20000 individus","response_rate":"50 000 par an"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Registre de morbidit\u00e9"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Donn\u00e9es anonymis\u00e9es, statistiques disponibles sur le site internet. Pour plus d'informations, contacter le responsable scientifique.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"12-03-2014","lastUpdatedAuto":null,"lastUpdatedManual":"17-06-2014","isContributorPI":"Non","contributorName":" Agence de la Biom\u00e9decine","contributorAffiliation":"AGENCE DE LA BIOMEDECINE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Echange de donn\u00e9es informatiques avec les centres clinico-biologique d'AMP","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"\u00e9tat de sant\u00e9 des patients, bilan d'inf\u00e9condit\u00e9,","biologicalDataDetails":"bilan spermiologique","isDataInBiobank":"Non","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}