<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/NCT01718119</url>
  </required_header>
  <id_info>
    <org_study_id>DA3803_HCG_III</org_study_id>
    <nct_id>NCT01718119</nct_id>
  </id_info>
  <brief_title>Clinical Trial Comparing the Efficacy and Safety of DA-3803 and Ovidrel</brief_title>
  <acronym>DA-3803</acronym>
  <official_title>Phase III Clinical Trial Comparing the Efficacy and Safety of DA-3803(Recombinant Human Chorionic Gonadotrophin) and Ovidrel for Inducting Final Follicular Maturation and Early Luteinization in Women Undergoing Ovulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dong-A Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dong-A ST Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the efficacy and safety of DA-3803(r-hCG) and Ovidrel&#xD;
      for inducting final follicular maturation and early luteinization in women undergoing&#xD;
      ovulation induction for assisted reproduction treatment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an single-blind, randomized, comparative multicentric, phase III study to evaluate&#xD;
      the safety and efficacy of DA-3803(r-hCG) in comparison with Ovidrel in the induction of&#xD;
      final follicle maturation and early luteinization in 180 Korean female subjects undergoing&#xD;
      superovulation. The study is organized on an outpatient basis in subjects undergoing assisted&#xD;
      reproductive technologies (ART). The subjects are randomized into 2 groups. One group receive&#xD;
      DA-3803(r-hCG) 250mcg and the other group receive Ovidrel®(r-hCG)250mcg. Each subject in both&#xD;
      groups receives a single injection of hCG when the follicular development was judged to be&#xD;
      adequate. Oocytes are retrieved 34-38 hours after r-hCG injection and fertilized in vitro.&#xD;
      Not more than 4 embryos are to be replaced. Progesterone is administered daily according to&#xD;
      center's normal practice, starting after the oocyte pick up and continuing until appropriate&#xD;
      time. The subject is followed up and the treatment outcome (negative pregnancy test or&#xD;
      pregnancy) is recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <phase>Phase 3</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the efficacy and safety of DA-3803(r-hCG)</measure>
    <time_frame>about 1 month after ART</time_frame>
    <description>the number of oocytes retrieved per patient following r-hCG administration, physical examination, clinical laboratory measurements, adverse events, injection-sited reactions, OHSS, number of multiple pregnancies</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the efficacy of DA-3803(r-hCG)</measure>
    <time_frame>about 1 month after ART</time_frame>
    <description>number of patients who received r-hCG with at least one oocyte retrieved, number of oocyte retrieved per number of follicles &gt;10mm diameter on the day of r-hCG, number of mature oocytes, number of 2PN fertilized oocytes, number of 2PN cleaved embryos, implantation rate per embryo transferred, number of biochemical and clinical pregnancies</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Hyperovulation Induction for Assisted Reproduction Treatment</condition>
  <arm_group>
    <arm_group_label>DA-3803</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects treated with DA-3803(r-hCG)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ovidrel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>subjects treated with Ovidrel(r-hCG)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>r-hCG</intervention_name>
    <description>r-hCG(250mcg) injection subcutaneously</description>
    <arm_group_label>DA-3803</arm_group_label>
    <arm_group_label>Ovidrel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infertility regular ovulatory menstrual cycles : 25~35days&#xD;
&#xD;
          -  BMI&lt;=30kg/m2&#xD;
&#xD;
          -  Early follicular phase serum levels are normal : FSH, LH, prolactin, testosterone&#xD;
&#xD;
          -  Both ovaries present and clinically normal uterine cavity&#xD;
&#xD;
          -  &lt; 3 previous ART cycles, no ART cycles for 2 menstrual cycles&#xD;
&#xD;
          -  semen analysis and ART are possible&#xD;
&#xD;
          -  informed couple consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With a poor response to gonadotrophin stimulation, such as ≤3 oocytes collected in any&#xD;
             previous ART cycle&#xD;
&#xD;
          -  Had previous severe ovarian hyperstimulation syndrome(OHSS)&#xD;
&#xD;
          -  Polycystic ovarian syndrome(PCOS)&#xD;
&#xD;
          -  Extra-uterine pregnancy within the last 3 months&#xD;
&#xD;
          -  A clinically significant uncontrolled endocrine diseases, chronic cardiovascular&#xD;
             disorders, hepatic, pulmonary and renal diseases&#xD;
&#xD;
          -  Known allergy,hypersensitivity or contraindication to FSH, hCG, progesterone and GnRH&#xD;
             antagonists&#xD;
&#xD;
          -  medication with human gonadotrophin preparations(FSH, LH, hCG) within 2 months&#xD;
&#xD;
          -  participation in another clinical trial within 1 month&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>TaeGi Yoon, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Cha Medical school Gangnam-Cha hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>DongHee Choi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cha Medical school Boondang-Cha hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>MiKyoung Goong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kwandong university medical school Cheil hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cha Medical school Boondang-Cha hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeong-Gi Do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cha Medical school Gangnam-Cha hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kwandong university medical school Cheil hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>February 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>August 12, 2013</last_update_submitted>
  <last_update_submitted_qc>August 12, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01718119
org study id: DA3803_HCG_III
nct id: NCT01718119
lead sponsor: 
has dmc: No
The purpose of this study is to compare the efficacy and safety of DA-3803(r-hCG) and Ovidrel
      for inducting final follicular maturation and early luteinization in women undergoing
      ovulation induction for assisted reproduction treatment
This is an single-blind, randomized, comparative multicentric, phase III study to evaluate
      the safety and efficacy of DA-3803(r-hCG) in comparison with Ovidrel in the induction of
      final follicle maturation and early luteinization in 180 Korean female subjects undergoing
      superovulation. The study is organized on an outpatient basis in subjects undergoing assisted
      reproductive technologies (ART). The subjects are randomized into 2 groups. One group receive
      DA-3803(r-hCG) 250mcg and the other group receive Ovidrel®(r-hCG)250mcg. Each subject in both
      groups receives a single injection of hCG when the follicular development was judged to be
      adequate. Oocytes are retrieved 34-38 hours after r-hCG injection and fertilized in vitro.
      Not more than 4 embryos are to be replaced. Progesterone is administered daily according to
      center's normal practice, starting after the oocyte pick up and continuing until appropriate
      time. The subject is followed up and the treatment outcome (negative pregnancy test or
      pregnancy) is recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: the efficacy and safety of DA-3803(r-hCG)
time frame: about 1 month after ART
description: the number of oocytes retrieved per patient following r-hCG administration, physical examination, clinical laboratory measurements, adverse events, injection-sited reactions, OHSS, number of multiple pregnancies
measure: the efficacy of DA-3803(r-hCG)
time frame: about 1 month after ART
description: number of patients who received r-hCG with at least one oocyte retrieved, number of oocyte retrieved per number of follicles >10mm diameter on the day of r-hCG, number of mature oocytes, number of 2PN fertilized oocytes, number of 2PN cleaved embryos, implantation rate per embryo transferred, number of biochemical and clinical pregnancies
arm group label: DA-3803
arm group type: Experimental
description: subjects treated with DA-3803(r-hCG)
arm group label: Ovidrel
arm group type: Active Comparator
description: subjects treated with Ovidrel(r-hCG)
intervention type: Drug
intervention name: r-hCG
description: r-hCG(250mcg) injection subcutaneously
arm group label: DA-3803
arm group label: Ovidrel
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 38 Years
healthy volunteers: No
last name: TaeGi Yoon, MD
role: Study Chair
affiliation: Cha Medical school Gangnam-Cha hospital
last name: DongHee Choi, MD
role: Principal Investigator
affiliation: Cha Medical school Boondang-Cha hospital
last name: MiKyoung Goong, MD
role: Principal Investigator
affiliation: Kwandong university medical school Cheil hospital
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor