{"doc_desc":{"title":"Embryo quality evaluation in Intra Cytoplasmic Sperm Injection (ICSI) cycles with Fertimorph system","idno":"FRESH-PEF197-en","producers":[{"name":"","affiliation":""}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF197-en","IDno":{"metadata_no":[{"agency":"PEF","code":"197"},{"agency":"FReSH","code":"FRESH-PEF197"}]},"title":"Embryo quality evaluation in Intra Cytoplasmic Sperm Injection (ICSI) cycles with Fertimorph system","alternate_title":"QUALIMORPH"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Philippe;NIEZ","PILabo":"","affiliationName":"ASTRAZENECA (FRANCE)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"558201075","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"philippe.niez@ferring.com","isContact":"Yes"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Epidemiology France Portal (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","email":"philippe.niez@ferring.com","type":"contact","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":"In Vitro Fertilization (IVF)"},{"keyword":"FertiMORPH system"},{"keyword":"embryo quality"},{"keyword":"Intra Cytoplasmic Sperm Injection ICSI"}],"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":"Contact with health services for medically assisted reproduction","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/299316821","title":"CIM-11"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"Evaluate the concordance between the embryo quality appreciated by the biologist according to his normal technique and according to the Fertimorph system","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":"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\": \"Embryos coming from couples having the following characteristics: -Criteria linked to the woman: woman with normal response, all infertility etiologies, aged up to 36 years, maximum of one prior assisted reproduction technique (ART) cycle, current ART cycle with ICSI with ejaculated or frozen sperm, normal ovarian reserve (evaluated via hormone assays and where applicable by an antral follicle count),  with a normal uterus and without hydrosalpinx.  -Criteria linked to the spouse: diagnosed male infertility, where applicable normal male karyotype,  -Criteria linked to the studied attempt: at least 5 mature (MII) ovocytes retrieved, maximum of two embryos transferred.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Biological data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Others"}]},"method":{"data_collection":{"time_method":"One-time cross-sectional study","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\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"130"},"method_notes":"Observational Study","study_class":"Completed study","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"To be defined\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","conditions":"","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":"19-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2020","isContributorPI":"No","contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industry"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"No","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":"No"},"geographicalCoverage":{"geoDetail":"Multi-center study - 7 centers in France: Besan\u00e7on, Grenoble, Lille, Montpellier, Strasbourg, Toulouse, Brest"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Number and quality of the ovocytes, fertilization parameters, number and quality of the embryos","isDataInBiobank":"No","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}