<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/NCT03822429</url>
  </required_header>
  <id_info>
    <nct_id>NCT03822429</nct_id>
  </id_info>
  <brief_title>Cumulative Live Birth Rate (CLBR) After a Complete IVF Cycle: a Single Center Retrospective Study</brief_title>
  <official_title>Cumulative Live Birth Rate (CLBR) After a Complete IVF Cycle: a Single Center</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Clinico Humanitas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Clinico Humanitas</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      We need to identify a new parameter to evaluate the success rate of IVF techniques. CLBR has&#xD;
      been suggested as a suitable way for reporting success of IVF program: it implies capturing&#xD;
      the totality of live birth episodes following successive treatments. For patients CLBR is&#xD;
      easy to understand because it summarizes the chance of a live birth over an entire treatment&#xD;
      period. CLBR per oocyte retrieval is more meaningful as it is the best indicator of quality&#xD;
      and success in IVF and it allows the best indicator of quality and success in IVF with&#xD;
      different strategies for freezing embryos.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Traditionally, studies about In Vitro Fertilization (IVF) examine and report the 'per cycle'&#xD;
      and 'per embryo transfer procedure' probability of pregnancy and delivery .Thus, each IVF&#xD;
      cycle is considered as a unique entity even if several embryo transfers (ET) have been&#xD;
      performed after a single ovarian stimulation.&#xD;
&#xD;
      Thanks to the latest technological refinements, in recent years the number of thawed frozen&#xD;
      ETs has greatly increased and has become an essential feature of IVF procedures .This&#xD;
      practice has been encouraged by the strategy of preferring single ET for reducing multiple&#xD;
      pregnancy and preventing ovarian hyperstimulation in high risk women.&#xD;
&#xD;
      Moreover, at first infertility counseling patients usually want to know which is their&#xD;
      possibility to have a live birth child with ART treatment, after the first stimulation cycle,&#xD;
      also involving the chances after frozen ET or frozen oocytes injection.&#xD;
&#xD;
      Live birth rate (LBR) after a single fresh or frozen ET appears, at present time, to be an&#xD;
      insufficient parameter for a realistic evaluation of the efficacy of an IVF program.&#xD;
&#xD;
      We need to identify a new parameter for the evaluation of the success rate of IVF techniques&#xD;
      which should incorporate outcomes associated with a single controlled ovarian stimulation&#xD;
      cycle. Specifically, Cumulative live birth rate (CLBR) has been suggested as a suitable way&#xD;
      for reporting success of IVF program : it implies capturing the totality of live birth&#xD;
      episodes following successive treatments.&#xD;
&#xD;
      For patients CLBR is very reliable and easy to understand because it summarizes the chance of&#xD;
      a live birth over an entire treatment period . CLBR per oocyte retrieval is more meaningful&#xD;
      as it is the best indicator of quality and success in IVF and it allows the best indicator of&#xD;
      quality and success in IVF with different strategies for freezing embryos.&#xD;
&#xD;
      The aim of the present study was to report our experience on CLBR after the first stimulation&#xD;
      cycle and to determinate which prognostic factors contribute to positive pregnancy outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2010</start_date>
  <completion_date type="Actual">December 31, 2015</completion_date>
  <primary_completion_date type="Actual">December 31, 2015</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>2 years</time_frame>
    <description>number of live Birth derived from a complete controlled ovarian stimulation</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">6375</enrollment>
  <condition>ART</condition>
  <condition>Fertility Disorders</condition>
  <arm_group>
    <arm_group_label>women &lt; 35 years old</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>women between 36 and 38 years old</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>women between 39 and 40 years</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>women &gt; 41 years old</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Controlled ovarian stimulation</intervention_name>
    <description>Hormonal therapy to induce ovulation by multiple ovarian follicles</description>
    <arm_group_label>women &lt; 35 years old</arm_group_label>
    <arm_group_label>women &gt; 41 years old</arm_group_label>
    <arm_group_label>women between 36 and 38 years old</arm_group_label>
    <arm_group_label>women between 39 and 40 years</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients admitted to Humanitas Research hospital for undergoing their first IVF cycle ,&#xD;
        except cycle with any pre-implatation genetic test&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients admitted to Humanitas Research hospital for undergoing their first IVF&#xD;
             cycle&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cycle with any pre-implatation genetic test&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>46 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CLBR</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03822429
nct id: NCT03822429
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
We need to identify a new parameter to evaluate the success rate of IVF techniques. CLBR has
      been suggested as a suitable way for reporting success of IVF program: it implies capturing
      the totality of live birth episodes following successive treatments. For patients CLBR is
      easy to understand because it summarizes the chance of a live birth over an entire treatment
      period. CLBR per oocyte retrieval is more meaningful as it is the best indicator of quality
      and success in IVF and it allows the best indicator of quality and success in IVF with
      different strategies for freezing embryos.
Traditionally, studies about In Vitro Fertilization (IVF) examine and report the 'per cycle'
      and 'per embryo transfer procedure' probability of pregnancy and delivery .Thus, each IVF
      cycle is considered as a unique entity even if several embryo transfers (ET) have been
      performed after a single ovarian stimulation.

      Thanks to the latest technological refinements, in recent years the number of thawed frozen
      ETs has greatly increased and has become an essential feature of IVF procedures .This
      practice has been encouraged by the strategy of preferring single ET for reducing multiple
      pregnancy and preventing ovarian hyperstimulation in high risk women.

      Moreover, at first infertility counseling patients usually want to know which is their
      possibility to have a live birth child with ART treatment, after the first stimulation cycle,
      also involving the chances after frozen ET or frozen oocytes injection.

      Live birth rate (LBR) after a single fresh or frozen ET appears, at present time, to be an
      insufficient parameter for a realistic evaluation of the efficacy of an IVF program.

      We need to identify a new parameter for the evaluation of the success rate of IVF techniques
      which should incorporate outcomes associated with a single controlled ovarian stimulation
      cycle. Specifically, Cumulative live birth rate (CLBR) has been suggested as a suitable way
      for reporting success of IVF program : it implies capturing the totality of live birth
      episodes following successive treatments.

      For patients CLBR is very reliable and easy to understand because it summarizes the chance of
      a live birth over an entire treatment period . CLBR per oocyte retrieval is more meaningful
      as it is the best indicator of quality and success in IVF and it allows the best indicator of
      quality and success in IVF with different strategies for freezing embryos.

      The aim of the present study was to report our experience on CLBR after the first stimulation
      cycle and to determinate which prognostic factors contribute to positive pregnancy outcomes.
observational model: Cohort
time perspective: Retrospective
measure: Cumulative Live Birth Rate
time frame: 2 years
description: number of live Birth derived from a complete controlled ovarian stimulation
arm group label: women < 35 years old
arm group label: women between 36 and 38 years old
arm group label: women between 39 and 40 years
arm group label: women > 41 years old
intervention type: Drug
intervention name: Controlled ovarian stimulation
description: Hormonal therapy to induce ovulation by multiple ovarian follicles
arm group label: women < 35 years old
arm group label: women > 41 years old
arm group label: women between 36 and 38 years old
arm group label: women between 39 and 40 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 46 Years
healthy volunteers: No
responsible party type: Sponsor
sharing ipd: No