<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/NCT02185326</url>
  </required_header>
  <id_info>
    <org_study_id>WHE062013</org_study_id>
    <nct_id>NCT02185326</nct_id>
  </id_info>
  <brief_title>Microflare Protocol in Poor Responders</brief_title>
  <official_title>Growth Hormone Co-treatment With the Microflare Stimulation Protocol in IVF/ICSI, Can it be a New Hope for Poor Responders?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Woman's Health University Hospital, Egypt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Woman's Health University Hospital, Egypt</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The effect of use of the microflare down regulation protocol on the outcome of the IVF/ICSI&#xD;
      cycles in poor responders&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The microflare as a method of down regulation protocol can be used to prepare the females&#xD;
      suffering from poor ovarian reserve to undergo IVF/ICSI cycles. In this study we are trying&#xD;
      to outline its effect on the clinical pregnancy rate as a main primary outcome, and to&#xD;
      compare its use with the addition of growth hormone to the same protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical pregnancy rates</measure>
    <time_frame>15 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">145</enrollment>
  <condition>Female Infertility Due to Diminished Ovarian Reserve</condition>
  <arm_group>
    <arm_group_label>Microflare and growth hormone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the patients in this group were given oral contraceptive pills (OCPs) for 28 days, this was followed by 2 days free. Triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. was then started daily followed by human menopausal gonadotropin IM daily (HMG 75 IU, Merional, IBSA) 3 days later. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Microflare protocol alone</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>the patients in this group were given oral contraceptive pills (OCPs) for 28 days, this was followed by 2 days free. Triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. was then started daily followed by human menopausal gonadotropin IM daily (HMG 75 IU, Merional, IBSA) 3 days later</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Growth hormone (Norditropin, Novo nordisk)</intervention_name>
    <description>Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.</description>
    <arm_group_label>Microflare and growth hormone</arm_group_label>
    <other_name>Norditropin, Novo nordisk</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  females fulfilling the criteria of the ESHRE consensus 2011:&#xD;
&#xD;
        At least two of the following three features must be present:&#xD;
&#xD;
        (i) Advanced maternal age (≥40 years) or any other risk factor for POR; (ii) A previous POR&#xD;
        (≤3 oocytes with a conventional stimulation protocol); (iii) An abnormal ovarian reserve&#xD;
        test (i.e. AFC ,5-7 follicles or AMH ,0.5 -1.1 ng/ml).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women who suffer from any other cause of infertility other than poor ovarian reserve&#xD;
&#xD;
          -  refusal of the patient to consent for using her data in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dina M Dakhly, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kasr el aini hospital</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>July 1, 2014</study_first_submitted>
  <study_first_submitted_qc>July 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>January 26, 2015</last_update_submitted>
  <last_update_submitted_qc>January 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Woman's Health University Hospital, Egypt</investigator_affiliation>
    <investigator_full_name>Dina Mohamed Refaat Dakhly</investigator_full_name>
    <investigator_title>Lecturer of obstetrics and gynecology</investigator_title>
  </responsible_party>
  <keyword>Poor responders</keyword>
  <keyword>Poor ovarian response</keyword>
  <keyword>IVF/ICSI</keyword>
  <keyword>Microflare protocol</keyword>
  <keyword>Growth hormone</keyword>
  <keyword>Oral contraceptive pills</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hormones</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/NCT02185326
org study id: WHE062013
nct id: NCT02185326
lead sponsor: 
has dmc: Yes
The effect of use of the microflare down regulation protocol on the outcome of the IVF/ICSI
      cycles in poor responders
The microflare as a method of down regulation protocol can be used to prepare the females
      suffering from poor ovarian reserve to undergo IVF/ICSI cycles. In this study we are trying
      to outline its effect on the clinical pregnancy rate as a main primary outcome, and to
      compare its use with the addition of growth hormone to the same protocol.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinical pregnancy rates
time frame: 15 months
arm group label: Microflare and growth hormone
arm group type: Experimental
description: the patients in this group were given oral contraceptive pills (OCPs) for 28 days, this was followed by 2 days free. Triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. was then started daily followed by human menopausal gonadotropin IM daily (HMG 75 IU, Merional, IBSA) 3 days later. Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.
arm group label: Microflare protocol alone
arm group type: No Intervention
description: the patients in this group were given oral contraceptive pills (OCPs) for 28 days, this was followed by 2 days free. Triptorelin (Decapeptyl Ferring Pharmaceuticals, Germany) 0.05 mg/day S.C. was then started daily followed by human menopausal gonadotropin IM daily (HMG 75 IU, Merional, IBSA) 3 days later
intervention type: Drug
intervention name: Growth hormone (Norditropin, Novo nordisk)
description: Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.
arm group label: Microflare and growth hormone
other name: Norditropin, Novo nordisk
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
last name: Dina M Dakhly, MD
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Woman's Health University Hospital, Egypt
investigator full name: Dina Mohamed Refaat Dakhly
investigator title: Lecturer of obstetrics and gynecology
mesh term: Infertility
mesh term: Infertility, Female
mesh term: Hormones