<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/NCT01678651</url>
  </required_header>
  <id_info>
    <org_study_id>MAD-NB-08-2012-01</org_study_id>
    <nct_id>NCT01678651</nct_id>
  </id_info>
  <brief_title>Embryo Kinetics and Stimulation Protocol: Recombinant Follicle Stimulating Hormone (FSH) Versus Human FSH</brief_title>
  <official_title>Embryo Kinetcis From Embryos Deriving From Egg Donation Cycle With Different Stimulation Protocol: Recombinant FSH vs Human FSH</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IVI Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IVI Madrid</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Different kinetics markers have been proposed to select embryos with higher implantation&#xD;
      rates. The effect of external factors on these markers, such as the stimulation protocol&#xD;
      should be analyzed. There are two different types of FSH that are commonly used for in vitro&#xD;
      fertilization (IVF) in egg donation cycles, recombinant FSH and human FSH. The effect of each&#xD;
      kind of hormone on embryo kinetcis is still unknown. The aim of this study is to observe if&#xD;
      there is a difference in embryo kinetics and morphology as well as oocyte morphological&#xD;
      parameters between the two types of FSH and therefore to analyze if such markers can be used&#xD;
      despite of the stimulation protocols chosen.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>time of cell cleavage</measure>
    <time_frame>February 2012</time_frame>
    <description>Analysis of cell cleavage</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Embryo and oocyte morphology</measure>
    <time_frame>February 2012</time_frame>
    <description>Analysis of all oocytes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outcome rates (implantation, pregnancy and miscarriage rate)</measure>
    <time_frame>February 2012</time_frame>
    <description>Time requierd to know all the implantation, pregnancy and miscarriage rate</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Embryo Kinetics</condition>
  <arm_group>
    <arm_group_label>Human FSH</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Human FSH</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Recombinant FSH</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Recombinant FSH</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Stimulation with human FSH</intervention_name>
    <description>Human FSH</description>
    <arm_group_label>Human FSH</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Stimulation with recombinant FSH</intervention_name>
    <description>Recombinant FSH</description>
    <arm_group_label>Recombinant FSH</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        •Egg donation cycles with more than 8MII in oocyte retrieval day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Male factor&#xD;
&#xD;
          -  Uterine malformations&#xD;
&#xD;
          -  genetic alterations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Insituto Valenciano de Infertilida</name>
      <address>
        <city>Madrid</city>
        <zip>28023</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>February 23, 2016</last_update_submitted>
  <last_update_submitted_qc>February 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>time-lapse, FSH, kinetics</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Follicle Stimulating Hormone</mesh_term>
  </intervention_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/NCT01678651
org study id: MAD-NB-08-2012-01
nct id: NCT01678651
lead sponsor: 
has dmc: No
Different kinetics markers have been proposed to select embryos with higher implantation
      rates. The effect of external factors on these markers, such as the stimulation protocol
      should be analyzed. There are two different types of FSH that are commonly used for in vitro
      fertilization (IVF) in egg donation cycles, recombinant FSH and human FSH. The effect of each
      kind of hormone on embryo kinetcis is still unknown. The aim of this study is to observe if
      there is a difference in embryo kinetics and morphology as well as oocyte morphological
      parameters between the two types of FSH and therefore to analyze if such markers can be used
      despite of the stimulation protocols chosen.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: time of cell cleavage
time frame: February 2012
description: Analysis of cell cleavage
measure: Embryo and oocyte morphology
time frame: February 2012
description: Analysis of all oocytes
measure: Outcome rates (implantation, pregnancy and miscarriage rate)
time frame: February 2012
description: Time requierd to know all the implantation, pregnancy and miscarriage rate
arm group label: Human FSH
arm group type: Active Comparator
description: Human FSH
arm group label: Recombinant FSH
arm group type: Active Comparator
description: Recombinant FSH
intervention type: Procedure
intervention name: Stimulation with human FSH
description: Human FSH
arm group label: Human FSH
intervention type: Procedure
intervention name: Stimulation with recombinant FSH
description: Recombinant FSH
arm group label: Recombinant FSH
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Follicle Stimulating Hormone