<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/NCT03290911</url>
  </required_header>
  <id_info>
    <org_study_id>15/17</org_study_id>
    <nct_id>NCT03290911</nct_id>
  </id_info>
  <brief_title>Retrospective Trial on Low Prognosis Infertile Patients</brief_title>
  <official_title>An Observational Retrospective Cohort Trial on Low Prognosis Infertile Patient's Accessing IVF Cycle Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Clinico Humanitas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Serono International SA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </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>
      The main objective of this study is to analyze management of Controlled Ovarian Stimulation&#xD;
      (COS) protocols in low prognosis patients, secondly to observe the clinical outcomes&#xD;
      (Fertilization Rate, Pregnancy Rate, the Ongoing Pregnancy Rate and the Live birth Rate) and&#xD;
      the total units of gonadotrophins consume per M2 oocyte retrieved in this subgroup.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Humanitas Fertility Center maintains an external audit anonymized electronic research queries&#xD;
      system, exported from a certified only access web database, which at time of this analysis&#xD;
      (cycles at December 31th 2016) include 26,883 consecutive fresh non-donors IVF cycles.&#xD;
      Patients who underwent these cycles had consented in writing that their medical records could&#xD;
      be used for research purposes, as long as the patients' anonymity was protected and&#xD;
      confidentiality of the medical record was assured. Since both of these conditions were met,&#xD;
      this study has been approved on March 2th 2017 with an expedited review and approval protocol&#xD;
      by the center's Institutional Review Board (IRB).&#xD;
&#xD;
      At least 2,000 expected low prognosis patients in the Humanitas Fertility Center Database out&#xD;
      of 12,545 cycles performed in the period 2010-2015 with completed pregnancy follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2010</start_date>
  <completion_date type="Actual">September 1, 2017</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>induction protocol type</measure>
    <time_frame>6 years</time_frame>
    <description>number of antagonist and agonist protocols/ total numbers</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fertilization Rate</measure>
    <time_frame>6 years</time_frame>
    <description>fertilized oocytes/ number of oocytes used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy Rate</measure>
    <time_frame>6 years</time_frame>
    <description>number of gestational sacs/ number of embryos transferred</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ongoing Pregnancy Rate</measure>
    <time_frame>6 years</time_frame>
    <description>number of pregnancy &gt; 20 weeks/ total pregnancies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Live Birth Rate</measure>
    <time_frame>6 years</time_frame>
    <description>number babies born/ total pregnancies</description>
  </secondary_outcome>
  <enrollment type="Actual">26883</enrollment>
  <condition>Infertility, Female</condition>
  <condition>Fertility Disorders</condition>
  <eligibility>
    <study_pop>
      <textblock>
        26,883 consecutive fresh non-donors IVF cycles. Patients who underwent these cycles had&#xD;
        consented in writing that their medical records could be used for research purposes, as&#xD;
        long as the patients' anonymity was protected and confidentiality of the medical record was&#xD;
        assured. Since both of these conditions were met, this study has been approved on March 2th&#xD;
        2017 with an expedited review and approval protocol by the center's Institutional Review&#xD;
        Board (IRB).&#xD;
&#xD;
        At least 2,000 expected low prognosis patients in the Humanitas Fertility Center Database&#xD;
        out of 12,545 cycles performed in the period 2010-2015 with completed pregnancy follow-up.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≤ 44&#xD;
&#xD;
          -  Body Mass Index; 18 ≤ BMI ≥ 27&#xD;
&#xD;
          -  Number of oocytes retrieved ≤ 9&#xD;
&#xD;
          -  Cycles performed between January 2010 - December 2015&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 44&#xD;
&#xD;
          -  Number of oocytes retrieved ≥ 10&#xD;
&#xD;
          -  Abnormal uterine cavity&#xD;
&#xD;
          -  Endometriosis III-IV stage or adenomyosis&#xD;
&#xD;
          -  Testicular spermatozoa PGS (Preimplantation Genetic Screening) cycles&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 22, 2017</last_update_submitted>
  <last_update_submitted_qc>September 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>low responders</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</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/NCT03290911
org study id: 15/17
nct id: NCT03290911
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The main objective of this study is to analyze management of Controlled Ovarian Stimulation
      (COS) protocols in low prognosis patients, secondly to observe the clinical outcomes
      (Fertilization Rate, Pregnancy Rate, the Ongoing Pregnancy Rate and the Live birth Rate) and
      the total units of gonadotrophins consume per M2 oocyte retrieved in this subgroup.
Humanitas Fertility Center maintains an external audit anonymized electronic research queries
      system, exported from a certified only access web database, which at time of this analysis
      (cycles at December 31th 2016) include 26,883 consecutive fresh non-donors IVF cycles.
      Patients who underwent these cycles had consented in writing that their medical records could
      be used for research purposes, as long as the patients' anonymity was protected and
      confidentiality of the medical record was assured. Since both of these conditions were met,
      this study has been approved on March 2th 2017 with an expedited review and approval protocol
      by the center's Institutional Review Board (IRB).

      At least 2,000 expected low prognosis patients in the Humanitas Fertility Center Database out
      of 12,545 cycles performed in the period 2010-2015 with completed pregnancy follow-up.
observational model: Cohort
time perspective: Retrospective
measure: induction protocol type
time frame: 6 years
description: number of antagonist and agonist protocols/ total numbers
measure: Fertilization Rate
time frame: 6 years
description: fertilized oocytes/ number of oocytes used
measure: Pregnancy Rate
time frame: 6 years
description: number of gestational sacs/ number of embryos transferred
measure: Ongoing Pregnancy Rate
time frame: 6 years
description: number of pregnancy > 20 weeks/ total pregnancies
measure: Live Birth Rate
time frame: 6 years
description: number babies born/ total pregnancies
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 44 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Infertility
mesh term: Infertility, Female