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<docDscr>
  <citation>
    <titlStmt>
      <titl>Embryo quality evaluation in Intra Cytoplasmic Sperm Injection (ICSI) cycles with Fertimorph system</titl>
      <IDNo>FRESH-PEF197-en</IDNo>
    </titlStmt>
    <prodStmt>
      <producer abbr="" affiliation="" role=""></producer>
    </prodStmt>
    <verStmt>
      <version></version>
    </verStmt>
  </citation>
</docDscr>
<stdyDscr>
  <citation>
    <titlStmt>
      <titl>
                Embryo quality evaluation in Intra Cytoplasmic Sperm Injection (ICSI) cycles with Fertimorph system            </titl>
      <altTitl>
                    QUALIMORPH                </altTitl>
      <IDNo agency="FReSH-lang">
                FRESH-PEF197-en            </IDNo>
      <IDNo agency="PEF">
                    197                </IDNo>
      <IDNo agency="FReSH">
                    FRESH-PEF197                </IDNo>
    </titlStmt>
    <rspStmt>
      <AuthEnty>
                    Philippe NIEZ                                                                                                                            </AuthEnty>
      <AuthEnty affiliation="ASTRAZENECA (FRANCE)">
        <ExtLink title="ROR" URI="https://ror.org/016qv5070" role="organisation id"/>
        <ExtLink title="SIREN" URI="558201075" role="organisation id"/>
      </AuthEnty>
      <othId affiliation="" type="">
                                    </othId>
    </rspStmt>
    <prodStmt>
      <producer role="sponsor">
                                            FERRING SAS                    
                                    </producer>
      <prodPlac>
                Epidemiology France Portal (PEF)            </prodPlac>
      <fundAg>
                                            FERRING SAS                    
                                    </fundAg>
    </prodStmt>
    <distStmt>
      <distrbtr abbr="null">
                    null</distrbtr>
      <contact affiliation="ASTRAZENECA (FRANCE)" email="philippe.niez@ferring.com">
                    Philippe;NIEZ
                                            <ExtLink title="ROR" URI="https://ror.org/016qv5070" role="organisation id"/>
                                            <ExtLink title="SIREN" URI="558201075" role="organisation id"/>
                                    </contact>
      <depDate date="2026-06-17"/>
      <distDate date="2026-06-17"/>
    </distStmt>
    <biblCit format="">
            </biblCit>
    <holdings URI="null"/>
    <notes> </notes>
  </citation>
  <stdyInfo>
    <studyBudget/>
    <subject>
      <keyword vocab="" vocabURI="">
                    In Vitro Fertilization (IVF)</keyword>
      <keyword vocab="" vocabURI="">
                    FertiMORPH system</keyword>
      <keyword vocab="" vocabURI="">
                    embryo quality</keyword>
      <keyword vocab="" vocabURI="">
                    Intra Cytoplasmic Sperm Injection ICSI</keyword>
      <topcClas vocab="health theme">
                        Gynaecology and obstetrics                                                        <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/7de64596-5b0d-4977-8f98-b982ff2ec17d"/>
                                                            <ExtLink title="ESV" URI="http://data.europa.eu/8mn/euroscivoc/284ca20c-beb4-4abe-99fa-ef4513358bad"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D006176"/>
                                                            <ExtLink title="MeSH" URI="http://id.nlm.nih.gov/mesh/D009774"/>
                                                </topcClas>
      <topcClas vocab="cim-11">
                        Contact with health services for medically assisted reproduction                                            </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants: Use of care                    </topcClas>
      <topcClas vocab="health determinant">
                        Healthcare system determinants                    </topcClas>
    </subject>
    <abstract contentType="purpose">Evaluate the concordance between the embryo quality appreciated by the biologist according to his normal technique and according to the Fertimorph system</abstract>
    <abstract contentType="abstract">null</abstract>
    <sumDscr>
      <collDate event="start" date="2010-01-01"/>
      <collDate event="end" date="2010-12-31"/>
      <nation abbr="fr">
                    France
                                            <concept vocab="ISO" vocabURI="fr"/>
                                    </nation>
      <geogUnit/>
      <anlyUnit>
                Individuals            </anlyUnit>
      <universe level="type" clusion="I">Patients population                    </universe>
      <universe level="sex" clusion="I">Female                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D005260"/>
                                                    </universe>
      <universe level="age" clusion="I">Young Adult (19 to 24 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D055815"/>
                                                    </universe>
      <universe level="age" clusion="I">Adult (25 to 44 years)                                                            <concept vocab="MeSH" vocabURI="http://id.nlm.nih.gov/mesh/D000328"/>
                                                    </universe>
      <universe 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.                    </universe>
      <dataKind>Clinical data</dataKind>
      <dataKind>Biological data</dataKind>
    </sumDscr>
  </stdyInfo>
  <studyDevelopment>
    <developmentActivity type="primary evaluation">
      <description>Others</description>
    </developmentActivity>
  </studyDevelopment>
  <method>
    <dataColl>
      <timeMeth>One-time cross-sectional study</timeMeth>
      <sampProc>Other                                                            <concept vocab="CESSDA" vocabURI="Other"/>
                                                    </sampProc>
      <sampleFrame>
        <frameUnit>
          <unitType>Through organizations (health services or institutions</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>schools</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>businesses</unitType>
        </frameUnit>
        <frameUnit>
          <unitType>etc.)</unitType>
        </frameUnit>
      </sampleFrame>
      <targetSampleSize>
        <sampleSizeFormula>&lt; 500 individuals                        </sampleSizeFormula>
      </targetSampleSize>
      <collMode>Converting or copying information into a structured record                                                            <concept vocab="CESSDA" vocabURI="Transcription"/>
                                                    </collMode>
      <collMode>Interview with the participant (including clinical)                                                            <concept vocab="CESSDA" vocabURI="Interview"/>
                                                    </collMode>
    </dataColl>
    <notes>Observational Study</notes>
    <notes subject="research type">
                        Observational Study                    </notes>
    <anlyInfo>
      <respRate>130</respRate>
    </anlyInfo>
    <stdyClas>Completed study</stdyClas>
  </method>
  <dataAccs>
    <setAvail>
      <avlStatus>
                            To be defined                                                    </avlStatus>
    </setAvail>
  </dataAccs>
  <othrStdyMat>
    <relMat>Access on specific project only</relMat>
  </othrStdyMat>
</stdyDscr>
<dataDscr>
</dataDscr></codeBook>
