{"doc_desc":{"title":"National Registry on In-Vitro Fertilization Attempts","idno":"FRESH-PEF8378-en","producers":[{"name":" Agence de la Biom\u00e9decine","affiliation":"AGENCE DE LA BIOMEDECINE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF8378-en","IDno":{"metadata_no":[{"agency":"PEF","code":"8378"},{"agency":"FReSH","code":"FRESH-PEF8378"}]},"title":"National Registry on In-Vitro Fertilization Attempts","alternate_title":"FIV-ABM"},"study_authorization":{"agency":[]},"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":"Yes"},{"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":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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":"IVF"},{"keyword":"MAP"},{"keyword":"registry"},{"keyword":"sterility"},{"keyword":"in-vitro fertilisation"},{"keyword":"medically-assisted procreation"},{"keyword":"infertility"}],"topics":[{"topic":"Gynaecology and obstetrics","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":"Female infertility","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1237004558","title":"CIM-11"}]},{"topic":"Male infertility","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/753457327","title":"CIM-11"}]},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"The objective of this registry is to provide a comprehensive catalogue of in vitro fertilisation activities in France (annual report on agency activity, regional analyses, etc..) and to assess the results, given associated factors such as: - The woman (age they began smoking, indication of infertility, etc.); - The man (smoking, indication of infertility, etc.); - Attempt (number of attempts, gamete origin, technique used, quality of embryos, etc.); The registry shall identify the donor couple's treatment path over several years, attempt by attempt, throughout different centres if required, and to provide recommendations in order to improve clinical practice for the patient; To monitor pregnancy and to assess the child's health at birth through an after-birth study.","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":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Female\",\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\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"IVF attempts (with or without ICSI) and the transfer of frozen embryos; - Intrauterine insemination or simple ovarian stimulation is not included.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['A data validation plan listing all quality checks for data from each progress report is established every year. This plan aims to define checks that may identify missing or inconsistent data. A data clarification request is systematically sent to centres so they may correct or clarify missing or inconsistent data.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth care consumption and services\r\nOthers"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Free access","sources":[],"target_sample_size":">= 20000 individuals","response_rate":"50,000 per year."},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Morbidity registry"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Anonymous data, statistics available on website. Contact the scientist in charge for further information.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"12-03-2014","lastUpdatedAuto":null,"lastUpdatedManual":"17-06-2014","isContributorPI":"No","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":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Computer data is exchanged between MAP clinical biology centres.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"patient health status, sterility assessment.","biologicalDataDetails":"Sperm analysis.","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}