xml: <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/NCT05969834</url>
    </required_header>
    <id_info>
      <org_study_id>MD.20.09.370</org_study_id>
      <nct_id>NCT05969834</nct_id>
    </id_info>
    <brief_title>HCG Levels After Ovulation Triggering as Predictors of ICSI Outcome</brief_title>
    <official_title>Human Chorionic Gonadotropin Levels After Ovulation Triggering as Predictors of Intracytoplasmic Sperm Injection Outcome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mansoura University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mansoura University</source>
    <oversight_info>
      <has_dmc>No</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>
        This study aimed to assess the correlation between HCG levels after ovulation triggering and&#xD;
        ICSI outcomes, affected by HCG formulation and dose&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aims of this study are:&#xD;
  &#xD;
          1. To assess the correlation between serum human chorionic gonadotropin (hCG) level after&#xD;
             ovulation triggering and intracytoplasmic sperm injection (ICSI) outcome including:&#xD;
             oocyte maturity and quality, good quality embryo rate, blastocyst formation rate and&#xD;
             pregnancy rate&#xD;
  &#xD;
          2. To determine if there is an association between type and dose of the trigger and ICSI&#xD;
             outcome.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 31, 2021</start_date>
    <completion_date type="Actual">August 7, 2022</completion_date>
    <primary_completion_date type="Actual">July 19, 2022</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Clinical pregnancy rate</measure>
      <time_frame>6 weeks after embryo transfer</time_frame>
      <description>Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Oocyte maturation rate</measure>
      <time_frame>On 1 day of oocyte retrieval</time_frame>
      <description>Number of mature oocytes divided by the number of retrieved oocytes</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">100</enrollment>
    <condition>Infertility</condition>
    <arm_group>
      <arm_group_label>uHCG group</arm_group_label>
      <description>Trigger intramuscular (IM) administration of 10000 IU of uHCG</description>
    </arm_group>
    <arm_group>
      <arm_group_label>rHCG group</arm_group_label>
      <description>Trigger with subcutaneous (SC) administration of 6500 IU of rHCG</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dual trigger group</arm_group_label>
      <description>Combined SC administration of 0.1 mg of GnRHa and IM administration of 2500 IU of uHCG</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>uHCG</intervention_name>
      <description>Final oocyte maturation will be triggered by IM administration of 10000 IU of uHCG (Choriomon)</description>
      <arm_group_label>uHCG group</arm_group_label>
      <other_name>Choriomon</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>rHCG</intervention_name>
      <description>Final oocyte maturation will be triggered by SC administration of 6500 IU of rHCG (Ovitrelle)</description>
      <arm_group_label>rHCG group</arm_group_label>
      <other_name>Ovitrelle</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>uHCG and GnRHa</intervention_name>
      <description>Final oocyte maturation will be triggered by combined SC administration of 0.1 mg of GnRHa (Decapeptyl, Triptorelin) and IM administration of 2500 IU of uHCG (Choriomon)</description>
      <arm_group_label>Dual trigger group</arm_group_label>
      <other_name>Decapeptyl and Choriomon</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Women who will undergo controlled ovarian stimulation (COS) through fixed GnRH antagonist&#xD;
          protocol with ovulation triggering, according to the risk of OHSS, by: 1) urinary HCG&#xD;
          (uHCG); 2) recombinant HCG (rHCG); or 3) a combination of GnRHa and HCG (dual trigger)&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women who will undergo controlled ovarian stimulation (COS) through fixed GnRH&#xD;
               antagonist protocol&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  BMI &gt; 30 kg/m2&#xD;
  &#xD;
            -  Irregular menstruation&#xD;
  &#xD;
            -  Severe male factor abnormality&#xD;
  &#xD;
            -  Poor ovarian reserve&#xD;
  &#xD;
            -  Endometriosis&#xD;
  &#xD;
            -  Uterine abnormality&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>35 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Engy Abdallah, MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mansoura University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mohamed S Abdelhafez, MD</last_name>
      <role>Study Director</role>
      <affiliation>Mansoura University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Mohamed Elzayat, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Royal Center</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Amoura Abou-ElNaga, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Mansoura University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Royal Center</name>
        <address>
          <city>Mansoura</city>
          <state>Dakahlia</state>
          <zip>35516</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Ovulation triggering</keyword>
    <keyword>uHCG</keyword>
    <keyword>rHCG</keyword>
    <keyword>GnRH</keyword>
    <keyword>Dual trigger</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infertility</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Triptorelin Pamoate</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05969834
  org study id: MD.20.09.370
  nct id: NCT05969834
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aimed to assess the correlation between HCG levels after ovulation triggering and
        ICSI outcomes, affected by HCG formulation and dose
  The aims of this study are:
  
          1. To assess the correlation between serum human chorionic gonadotropin (hCG) level after
             ovulation triggering and intracytoplasmic sperm injection (ICSI) outcome including:
             oocyte maturity and quality, good quality embryo rate, blastocyst formation rate and
             pregnancy rate
  
          2. To determine if there is an association between type and dose of the trigger and ICSI
             outcome.
  observational model: Cohort
  time perspective: Prospective
  measure: Clinical pregnancy rate
  time frame: 6 weeks after embryo transfer
  description: Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after the ET) divided by the number of ET procedures
  measure: Oocyte maturation rate
  time frame: On 1 day of oocyte retrieval
  description: Number of mature oocytes divided by the number of retrieved oocytes
  arm group label: uHCG group
  description: Trigger intramuscular (IM) administration of 10000 IU of uHCG
  arm group label: rHCG group
  description: Trigger with subcutaneous (SC) administration of 6500 IU of rHCG
  arm group label: Dual trigger group
  description: Combined SC administration of 0.1 mg of GnRHa and IM administration of 2500 IU of uHCG
  intervention type: Drug
  intervention name: uHCG
  description: Final oocyte maturation will be triggered by IM administration of 10000 IU of uHCG (Choriomon)
  arm group label: uHCG group
  other name: Choriomon
  intervention type: Drug
  intervention name: rHCG
  description: Final oocyte maturation will be triggered by SC administration of 6500 IU of rHCG (Ovitrelle)
  arm group label: rHCG group
  other name: Ovitrelle
  intervention type: Drug
  intervention name: uHCG and GnRHa
  description: Final oocyte maturation will be triggered by combined SC administration of 0.1 mg of GnRHa (Decapeptyl, Triptorelin) and IM administration of 2500 IU of uHCG (Choriomon)
  arm group label: Dual trigger group
  other name: Decapeptyl and Choriomon
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 35 Years
  healthy volunteers: No
  last name: Engy Abdallah, MSc
  role: Principal Investigator
  affiliation: Mansoura University
  last name: Mohamed S Abdelhafez, MD
  role: Study Director
  affiliation: Mansoura University
  last name: Mohamed Elzayat, MD
  role: Study Chair
  affiliation: Royal Center
  last name: Amoura Abou-ElNaga, MD
  role: Study Chair
  affiliation: Mansoura University
  facility: 
  country: Egypt
  responsible party type: Sponsor
  mesh term: Infertility
  mesh term: Triptorelin Pamoate
  sharing ipd: Undecided