<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/NCT02994550</url>
  </required_header>
  <id_info>
    <org_study_id>CEIC E14/30</org_study_id>
    <nct_id>NCT02994550</nct_id>
  </id_info>
  <brief_title>Influence of FSH/LH Ratio in Controlled Ovarian Stimulation</brief_title>
  <official_title>Influence of FSH/LH Ratio in Controlled Ovarian Stimulation ( 2/1 Ratio vs 4/1 Ratio) in &gt;35 Years Women Undergoing IVF</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Cruces</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Cruces</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare different FSH/LH ratios in controlled ovarian stimulation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pregnancy achievement</measure>
    <time_frame>3 months after drug administration</time_frame>
    <description>To report our results in terms of pregnancy per embryo transfer</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">447</enrollment>
  <condition>Sub-Fertility</condition>
  <arm_group>
    <arm_group_label>FSH/LH 2/1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>dose: 300IU FSHrec and 150IU LHrec</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FSH/LH 4/1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>dose: 300IU FSHrec and 75IU LHrec</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FSH/LH</intervention_name>
    <arm_group_label>FSH/LH 2/1</arm_group_label>
    <arm_group_label>FSH/LH 4/1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing IVF cycles in Cruces University Hospital.&#xD;
&#xD;
          -  Signed IVF and cryopreservation informed consent.&#xD;
&#xD;
          -  Age &gt;35 and &lt;40 years.&#xD;
&#xD;
          -  FSH levels &lt;10 mIU/ml.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  When inclusion criteria are not fulfilled&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>August 2, 2022</last_update_submitted>
  <last_update_submitted_qc>August 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital de Cruces</investigator_affiliation>
    <investigator_full_name>Antonia Exposito</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>FSH</keyword>
  <keyword>LH</keyword>
  <keyword>IVF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02994550
org study id: CEIC E14/30
nct id: NCT02994550
lead sponsor: 
has dmc: No
The aim of this study is to compare different FSH/LH ratios in controlled ovarian stimulation
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pregnancy achievement
time frame: 3 months after drug administration
description: To report our results in terms of pregnancy per embryo transfer
arm group label: FSH/LH 2/1
arm group type: Experimental
description: dose: 300IU FSHrec and 150IU LHrec
arm group label: FSH/LH 4/1
arm group type: Experimental
description: dose: 300IU FSHrec and 75IU LHrec
intervention type: Drug
intervention name: FSH/LH
arm group label: FSH/LH 2/1
arm group label: FSH/LH 4/1
criteria: 
gender: Female
minimum age: 35 Years
maximum age: 40 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Hospital de Cruces
investigator full name: Antonia Exposito
investigator title: PhD
mesh term: Infertility
sharing ipd: Undecided