<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/NCT04407065</url>
  </required_header>
  <id_info>
    <org_study_id>Double trigger/more oocytes</org_study_id>
    <nct_id>NCT04407065</nct_id>
  </id_info>
  <brief_title>Double Trigger in Patients With Low Number of Oocytes Retrieved Per Number of Preovulatory Follicles</brief_title>
  <official_title>Double Trigger in Patients With Low Number of Oocytes Retrieved Per Number of Preovulatory Follicles. A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Riyadh Fertility and Reproductive Health center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Riyadh Fertility and Reproductive Health center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this randomized controlled trial is to determine whether co-administration of GnRH&#xD;
      agonist and hCG for final oocyte maturation ( 40 and 34 h prior to oocyte retrieval ,&#xD;
      respectively) can increase the oocytes yield in patients with history of poor oocytes yield,&#xD;
      despite normal response to COH, due to low (&lt;50%) number of oocytes retrieved per number of&#xD;
      follicles &gt; 14 mm in diameter on day of hCG administration&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">May 30, 2020</start_date>
  <completion_date type="Anticipated">February 2, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</primary_completion_date>
  <phase>Phase 2</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of oocytes retrieved</measure>
    <time_frame>First day after oocyte retrieval</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical pregnancy rate</measure>
    <time_frame>First 5 weeks after oocyte retrieval</time_frame>
    <description>The presence of gestational sac detected by ultrasound examination</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">56</enrollment>
  <condition>Infertility, Female</condition>
  <arm_group>
    <arm_group_label>Double trigger</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GnRH-agonist and HCG are used to trigger ovulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HCG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>HCG is used to trigger ovulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Double trigger</intervention_name>
    <description>Final follicular maturation is triggered by the co-administration of GnRH-agonist (Triptorelin acetate, decapeptyl 0.2 mg, Slough, United Kingdom) and 10000 IU of HCG, 40 and 34 h prior to oocyte retrieval, respectively</description>
    <arm_group_label>Double trigger</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HCG trigger</intervention_name>
    <description>Final follicular maturation is triggered by a dose of 10000 IU of HCG 36 h prior to oocyte retrieval</description>
    <arm_group_label>HCG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with history of poor oocytes yield in previous IVF attempt, despite normal&#xD;
             response to COH, due to low (&lt;50%) number of oocytes retrieved per number of follicles&#xD;
             &gt; 14 mm in diameter on day of hCG administration&#xD;
&#xD;
          -  Patients with 6 to 15 mature follicles on the day oocyte trigger in the current IVF-ET&#xD;
             attempt&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Endometriosis&#xD;
&#xD;
          -  PCOS&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Usama M Fouda, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Riyadh Fertility and Reproductive Health center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Usama M Fouda, Prof.</last_name>
    <phone>+201095401375</phone>
    <email>umfrfouda@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Riyadh Fertility and Reproductive Health center</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Usama M Fouda, Prof.</last_name>
      <phone>+201095401375</phone>
      <email>umfrfouda@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Haas J, Zilberberg E, Dar S, Kedem A, Machtinger R, Orvieto R. Co-administration of GnRH-agonist and hCG for final oocyte maturation (double trigger) in patients with low number of oocytes retrieved per number of preovulatory follicles--a preliminary report. J Ovarian Res. 2014 Aug 2;7:77. doi: 10.1186/1757-2215-7-77.</citation>
    <PMID>25296696</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>IVF</keyword>
  <keyword>HCG</keyword>
  <keyword>GnRH agonist trigger</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/NCT04407065
org study id: Double trigger/more oocytes
nct id: NCT04407065
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this randomized controlled trial is to determine whether co-administration of GnRH
      agonist and hCG for final oocyte maturation ( 40 and 34 h prior to oocyte retrieval ,
      respectively) can increase the oocytes yield in patients with history of poor oocytes yield,
      despite normal response to COH, due to low (<50%) number of oocytes retrieved per number of
      follicles > 14 mm in diameter on day of hCG administration
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Number of oocytes retrieved
time frame: First day after oocyte retrieval
measure: clinical pregnancy rate
time frame: First 5 weeks after oocyte retrieval
description: The presence of gestational sac detected by ultrasound examination
arm group label: Double trigger
arm group type: Experimental
description: GnRH-agonist and HCG are used to trigger ovulation
arm group label: HCG
arm group type: Active Comparator
description: HCG is used to trigger ovulation
intervention type: Drug
intervention name: Double trigger
description: Final follicular maturation is triggered by the co-administration of GnRH-agonist (Triptorelin acetate, decapeptyl 0.2 mg, Slough, United Kingdom) and 10000 IU of HCG, 40 and 34 h prior to oocyte retrieval, respectively
arm group label: Double trigger
intervention type: Drug
intervention name: HCG trigger
description: Final follicular maturation is triggered by a dose of 10000 IU of HCG 36 h prior to oocyte retrieval
arm group label: HCG
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Usama M Fouda, Prof.
role: Study Director
affiliation: Riyadh Fertility and Reproductive Health center
last name: Usama M Fouda, Prof.
phone: +201095401375
email: umfrfouda@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
citation: Haas J, Zilberberg E, Dar S, Kedem A, Machtinger R, Orvieto R. Co-administration of GnRH-agonist and hCG for final oocyte maturation (double trigger) in patients with low number of oocytes retrieved per number of preovulatory follicles--a preliminary report. J Ovarian Res. 2014 Aug 2;7:77. doi: 10.1186/1757-2215-7-77.
PMID: 25296696
responsible party type: Sponsor
mesh term: Infertility
mesh term: Infertility, Female