{"doc_desc":{"title":"Etude transversale sur embryons : \u00e9valuation de la qualit\u00e9 embryonnaire en \"Intra Cytoplasmic Sperm Injection\" (ICSI) avec le syst\u00e8me Fertimorph","idno":"FRESH-PEF197-fr","producers":[{"name":"","affiliation":""}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF197-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"197"},{"agency":"FReSH","code":"FRESH-PEF197"}]},"title":"Etude transversale sur embryons : \u00e9valuation de la qualit\u00e9 embryonnaire en \"Intra Cytoplasmic Sperm Injection\" (ICSI) avec le syst\u00e8me Fertimorph","alternate_title":"QUALIMORPH"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Philippe;NIEZ","firstname":"Philippe","lastname":"NIEZ","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/016qv5070","role":"organisation id"},{"title":"SIREN","uri":"558201075","role":"organisation id"}],"email":"philippe.niez@ferring.com","affiliationName":"ASTRAZENECA (FRANCE)","PILabo":"","isContact":true}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"FERRING SAS","extlink":[{"title":"SIREN","uri":"322624735","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"FERRING SAS","extlink":[{"title":"SIREN","uri":"322624735"}]}]},"distribution_statement":{"contact":[{"name":"Philippe;NIEZ","lastname":"NIEZ","firstname":"Philippe","type":"contact","email":"philippe.niez@ferring.com","affiliationName":"ASTRAZENECA (FRANCE)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/016qv5070","role":"organisation id","title":"ROR"},{"uri":"558201075","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"F\u00e9condation In Vitro (FIV)"},{"keyword":"Intra Cytoplasmic Sperm Injection ICSI"},{"keyword":"syst\u00e8me FertiMORPH"},{"keyword":"qualit\u00e9 embryonnaire"}],"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":"Recours aux serices de sant\u00e9 pour procr\u00e9ation m\u00e9dicalement assist\u00e9e","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/299316821","title":"CIM-11"}]},{"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":"Evaluer la concordance entre la qualit\u00e9 embryonnaire appr\u00e9ci\u00e9e par le biologiste selon sa technique habituelle et selon le syst\u00e8me Fertimorph","abstract":"","coll_dates":[{"start":"2010-01-01","end":"2010-12-31"}],"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\": \"Embryons issus de couples pr\u00e9sentant les caract\u00e9ristiques suivantes: -Crit\u00e8res li\u00e9s \u00e0 la femme: femme normor\u00e9pondeuse, toutes \u00e9tiologies d'infertilit\u00e9 confondues, \u00e2g\u00e9e de moins de 36 ans, ayant b\u00e9n\u00e9fici\u00e9 au maximun d'une aide m\u00e9dicale \u00e0 la procr\u00e9ation (AMP) ant\u00e9rieure, ayant b\u00e9n\u00e9fici\u00e9 d'une AMP par ICSI avec sperme \u00e9jacul\u00e9 ou sperme congel\u00e9, ayant une bonne r\u00e9serve ovarienne (\u00e9valu\u00e9e par des dosages hormonaux et le cas \u00e9ch\u00e9ant par un comptage des follicules antraux), pr\u00e9sentant ou non une dysovulation, avec un ut\u00e9rus normal et sans hydrosalpinx.  -Crit\u00e8res li\u00e9s au conjoint: infertilit\u00e9 masculine diagnostiqu\u00e9e, le cas \u00e9ch\u00e9ant caryotype masculin normal,  -Crit\u00e8res li\u00e9s \u00e0 la tentative \u00e9tudi\u00e9e: recueil d'au moins 5 ovocytes matures en MII lors de la tentative, deux embryons transf\u00e9r\u00e9s au maximum.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Autres"}]},"method":{"data_collection":{"time_method":"Etude transversale non r\u00e9p\u00e9t\u00e9e","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\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"130"},"method_notes":"Etude observationnelle","study_class":"\u00c9tude compl\u00e9t\u00e9e","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","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":"19-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2020","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":false,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Etude multicentrique - 7 centres en France: Besan\u00e7on, Grenoble, Lille, Montpellier, Strasbourg, Toulouse, Brest"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Nombre et qualit\u00e9 des ovocytes, param\u00e8tres de la f\u00e9condation, nombre et qualit\u00e9 des embryons","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}