<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03001648</url>
  </required_header>
  <id_info>
    <org_study_id>SMD-DEX-2016-02</org_study_id>
    <nct_id>NCT03001648</nct_id>
  </id_info>
  <brief_title>Cumulative Live Birth Rates in Patients With Repeated Implantation Failure (RIF) Undergoing Preimplantation Genetic Screening (PGS )</brief_title>
  <official_title>Cumulative Live Birth Rates in Patients With Repeated Implantation Failure (RIF) Undergoing Preimplantation Genetic Screening (PGS )</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Universitari Dexeus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Universitari Dexeus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single centre retrospective study in repeated implantation failure patients: &lt; 39&#xD;
      years old, at least 4 D3 good quality embryos or 2 good quality blastocysts transferred&#xD;
      without implantation, absence of known causes of implantation failures (uterine malformation,&#xD;
      thrombophilia, severe male factor, uncontrolled thyroid disfunction, autoimmune disease).&#xD;
&#xD;
      Patients scheduled for PGS underwent one or more stimulation cycles (oocyte or blastocyst&#xD;
      banking) in order to maximize chances of embryo transfer. PGS cycles are analyzed globally.&#xD;
      Aditionally, PGS cycles with a single stimulation cycle are analyzed in comparison to&#xD;
      standard IVF cycles.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative live birth rate</measure>
    <time_frame>at 24 months of first embryo transfer</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical Pregnancy Rate</measure>
    <time_frame>6 weeks after embryo transfer</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implantation Rate</measure>
    <time_frame>6 weeks after embryo transfer</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Miscarriage Rate</measure>
    <time_frame>Until 20 weeks after embryo transfer</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Infertility</condition>
  <condition>Preimplantation Genetic Screening</condition>
  <arm_group>
    <arm_group_label>PGS</arm_group_label>
    <description>Patients with RIF scheduled for PGS (Preimplantation Genetic Screening) with trophectoderm biopsy using arrays comparative genomic hybridation (aCGH) underwent one or more stimulation cycles. If euploid blastocysts were available, patients underwent frozen embryo transfer/s.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard IVF</arm_group_label>
    <description>Patients with RIF scheduled for standard IVF (In Vitro Fertilization) underwent a single stimulation cycle with the fresh embryo transfer and the subsequent frozen embryo transfers if there were surplus frozen embryos and the fresh embryo transfer was unsuccessful.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PGS (Preimplantation Genetic Screening) with trophectoderm biopsy</intervention_name>
    <description>PGS (Preimplantation Genetic Screening) with trophectoderm biopsy using arrays comparative genomic hybridizatioon (aCGH)</description>
    <arm_group_label>PGS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Repeated implantation failure patients: patients &lt;39 years old that have received at least&#xD;
        4 day 3 good quality embryos or 2 good quality blastocists with no implantation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  women &lt; 39 years&#xD;
&#xD;
          -  repeated implantation failure: at least 4 day 3 good quality embryos or 2 good quality&#xD;
             blastocysts transferred without implantation&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  partner with severe male factor, or abnormal sperm Fluorescence in situ hybridization&#xD;
             (FISH) analysis&#xD;
&#xD;
          -  presence of uni or bilateral hydrosalpinx, uterine malformation, thrombophilia,&#xD;
             uncontrolled thyroid disfunction or autoimmune disease&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus</name>
      <address>
        <city>Barcelona</city>
        <zip>08037</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>December 22, 2016</last_update_submitted>
  <last_update_submitted_qc>December 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institut Universitari Dexeus</investigator_affiliation>
    <investigator_full_name>Marta Devesa</investigator_full_name>
    <investigator_title>Staff member of Reproductive Unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03001648
org study id: SMD-DEX-2016-02
nct id: NCT03001648
lead sponsor: 
has dmc: No
This is a single centre retrospective study in repeated implantation failure patients: < 39
      years old, at least 4 D3 good quality embryos or 2 good quality blastocysts transferred
      without implantation, absence of known causes of implantation failures (uterine malformation,
      thrombophilia, severe male factor, uncontrolled thyroid disfunction, autoimmune disease).

      Patients scheduled for PGS underwent one or more stimulation cycles (oocyte or blastocyst
      banking) in order to maximize chances of embryo transfer. PGS cycles are analyzed globally.
      Aditionally, PGS cycles with a single stimulation cycle are analyzed in comparison to
      standard IVF cycles.
observational model: Cohort
time perspective: Retrospective
measure: Cumulative live birth rate
time frame: at 24 months of first embryo transfer
measure: Clinical Pregnancy Rate
time frame: 6 weeks after embryo transfer
measure: Implantation Rate
time frame: 6 weeks after embryo transfer
measure: Miscarriage Rate
time frame: Until 20 weeks after embryo transfer
arm group label: PGS
description: Patients with RIF scheduled for PGS (Preimplantation Genetic Screening) with trophectoderm biopsy using arrays comparative genomic hybridation (aCGH) underwent one or more stimulation cycles. If euploid blastocysts were available, patients underwent frozen embryo transfer/s.
arm group label: Standard IVF
description: Patients with RIF scheduled for standard IVF (In Vitro Fertilization) underwent a single stimulation cycle with the fresh embryo transfer and the subsequent frozen embryo transfers if there were surplus frozen embryos and the fresh embryo transfer was unsuccessful.
intervention type: Procedure
intervention name: PGS (Preimplantation Genetic Screening) with trophectoderm biopsy
description: PGS (Preimplantation Genetic Screening) with trophectoderm biopsy using arrays comparative genomic hybridizatioon (aCGH)
arm group label: PGS
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 38 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Institut Universitari Dexeus
investigator full name: Marta Devesa
investigator title: Staff member of Reproductive Unit
mesh term: Infertility