<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/NCT01720134</url>
  </required_header>
  <id_info>
    <org_study_id>S53562</org_study_id>
    <nct_id>NCT01720134</nct_id>
  </id_info>
  <brief_title>The Impact of Legally Enforced Embryo Transfer Policy (Belgian Law 2003) on Cumulative Delivery Rate.</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KU Leuven</source>
  <brief_summary>
    <textblock>
      Multiple pregnancy (MP) is associated with significant fetomaternal complications and a high&#xD;
      cost. The multiple pregnancy rate per cycle (MPR) of treatment with Assisted Reproductive&#xD;
      Technology (ART) is 25 % or higher even in countries where ART is reimbursed, much higher&#xD;
      than the 1% after natural conception, related to the number of embryos transferred, and&#xD;
      preventable by single embryo transfer (SET). In Belgium, the laboratory costs for 6 fresh ART&#xD;
      cycles are reimbursed for female patients younger than 43 with a Belgian insurance number&#xD;
      since July 2003, but only if a limited number of embryos is transferred depending on female&#xD;
      age and cycle rank. Although this policy has resulted in a significant reduction in the MPR&#xD;
      after ART in Belgium from 24 % to 13 %, available data are cycle based and it is unknown if&#xD;
      the cumulative delivery rate per patient is affected by this legislation. The aim of this&#xD;
      study was to test the hypothesis that Belgian ART legislation since 2003, coupling lab&#xD;
      reimbursement to restriced embryo transfer policy, has resulted in a reduced CDR when&#xD;
      compared to the situation before 2003.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Actual">July 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</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 delivery rate</measure>
    <time_frame>1999-2006</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1258</enrollment>
  <condition>Impact of Legislation on Cumulative Delivery Rate</condition>
  <arm_group>
    <arm_group_label>after legislation 1st july 2003</arm_group_label>
    <description>2003-2006</description>
  </arm_group>
  <arm_group>
    <arm_group_label>before legislation 1st july 2003</arm_group_label>
    <description>1999-2003</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients undergoing IVF/ICSI cycles&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with their first IVF/ICSI cycle&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  cycles without oocytes or sperm, oocyte reception cycles, embryo reception cycles,&#xD;
             cycles with preimplantation genetic diagnosis/screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>43 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Leuven University Fertility Center</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>March 29, 2017</last_update_submitted>
  <last_update_submitted_qc>March 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Sophie Debrock</investigator_full_name>
    <investigator_title>Prof. Dr</investigator_title>
  </responsible_party>
  <!-- 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/NCT01720134
org study id: S53562
nct id: NCT01720134
lead sponsor: 
Multiple pregnancy (MP) is associated with significant fetomaternal complications and a high
      cost. The multiple pregnancy rate per cycle (MPR) of treatment with Assisted Reproductive
      Technology (ART) is 25 % or higher even in countries where ART is reimbursed, much higher
      than the 1% after natural conception, related to the number of embryos transferred, and
      preventable by single embryo transfer (SET). In Belgium, the laboratory costs for 6 fresh ART
      cycles are reimbursed for female patients younger than 43 with a Belgian insurance number
      since July 2003, but only if a limited number of embryos is transferred depending on female
      age and cycle rank. Although this policy has resulted in a significant reduction in the MPR
      after ART in Belgium from 24 % to 13 %, available data are cycle based and it is unknown if
      the cumulative delivery rate per patient is affected by this legislation. The aim of this
      study was to test the hypothesis that Belgian ART legislation since 2003, coupling lab
      reimbursement to restriced embryo transfer policy, has resulted in a reduced CDR when
      compared to the situation before 2003.
observational model: Cohort
time perspective: Retrospective
measure: cumulative delivery rate
time frame: 1999-2006
arm group label: after legislation 1st july 2003
description: 2003-2006
arm group label: before legislation 1st july 2003
description: 1999-2003
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 43 Years
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Sophie Debrock
investigator title: Prof. Dr