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/NCT06023602</url>
    </required_header>
    <id_info>
      <org_study_id>2023-038</org_study_id>
      <nct_id>NCT06023602</nct_id>
    </id_info>
    <brief_title>Effectiveness of Biosimilar Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a Gonadotropin-releasing Hormone（GnRH）Antagonist Protocol in Women Undergoing IVF</brief_title>
    <official_title>Effectiveness of Biosimilar Cetrorelix Acetate Versus Reference Cetrorelix Acetate for Ovarian Stimulation Using a GnRH Antagonist Protocol in Women Undergoing IVF: A Multicenter Non-inferiority, Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Northwest Women's and Children's Hospital, Xi'an, Shaanxi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Northwest Women's and Children's Hospital, Xi'an, Shaanxi</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare the clinical outcomes using different&#xD;
        cetrorelix acetate in the context of a GnRH antagonist protocol for ovarian stimulation in&#xD;
        women undergoing IVF or intracytoplasmic sperm injection(ICSI) treatment.The main question it&#xD;
        aims to answer is whether the biosimilar cetrorelix acetate is non-inferior to the reference&#xD;
        product in the GnRH antagonist based protocol for women undergoing IVF. Ovarian stimulation&#xD;
        was achieved by several types of follicle-stimulating hormone(FSH) or by FSH combined with&#xD;
        luteinizing hormone activity. Daily dose of biosimilar cetrorelix acetate (0.25 mg SC) or&#xD;
        original cetrorelix acetate (0.25 mg SC) will be administered when the lead follicle was 14&#xD;
        mm. When more than two follicles reached 17 mm, oocyte maturation was triggered with 250 mcg&#xD;
        of recombinant human chorionic gonadotropin.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2024</primary_completion_date>
    <phase>N/A</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cumulative live birth rate</measure>
      <time_frame>Through study completion, an average of 18 months</time_frame>
      <description>For the first live birth (gestation≥ 24 weeks) in one in vitro fertilization/intracytoplasmic sperm injection egg retrieval cycle (fresh and frozen-thawed embryo transfer cycle)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">1338</enrollment>
    <condition>Infertility</condition>
    <arm_group>
      <arm_group_label>Biosimilar cetrorelix acetate</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Reference cetrorelix acetate</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Biosimilar cetrorelix acetate</intervention_name>
      <description>biosimilar cetrorelix acetate (0.25 mg SC)</description>
      <arm_group_label>Biosimilar cetrorelix acetate</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Reference cetrorelix acetate</intervention_name>
      <description>reference cetrorelix acetate (0.25 mg SC)</description>
      <arm_group_label>Reference cetrorelix acetate</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Infertile couples plan to undergo IVF / ICSI pregnancy treatment into screening&#xD;
               procedures and clinical study&#xD;
  &#xD;
                 1. All subjects should sign the informed consent form&#xD;
  &#xD;
                 2. Infertile women &lt;43 years old&#xD;
  &#xD;
                 3. With flexible GnRH antagonist&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects could not enter the study if they meet any one of the following criteria&#xD;
  &#xD;
                 1. Preimplantation Genetic Testing (PGT)&#xD;
  &#xD;
                 2. Untreated hydrosalpinges, moderate or severe endometriosis, recurrent spontaneous&#xD;
                    miscarriage, endometrial pathology, uterine malformations, etc&#xD;
  &#xD;
                 3. Endocrine diseases (such as hyperthyroidism, hyperprolactinemia, etc.) or other&#xD;
                    systemic disease and other systemic diseases (such as hypertension, diabetes,&#xD;
                    etc.)．&#xD;
  &#xD;
                 4. Other factors were considered inappropriate by the investigator to participate,&#xD;
                    or assisted reproductive technology/pregnancy contraindications&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>42 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>HE CAI, Doctor</last_name>
      <phone>+8613581613908</phone>
      <email>caihe@bjmu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Juanzi Shi, Doctor</last_name>
      <phone>+18602991568</phone>
      <email>shijuanziart@126.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>He Cai</name>
        <address>
          <city>Xi'an</city>
          <state>None Selected</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>He Cai</last_name>
        <email>caihe@bjmu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <results_reference>
      <citation>Dovey S, McIntyre K, Jacobson D, Catov J, Wakim A. Is a premature rise in luteinizing hormone in the absence of increased progesterone levels detrimental to pregnancy outcome in GnRH antagonist in vitro fertilization cycles. Fertil Steril. 2011 Sep;96(3):585-9. doi: 10.1016/j.fertnstert.2011.06.042. Epub 2011 Jul 20.</citation>
      <PMID>21774931</PMID>
    </results_reference>
    <results_reference>
      <citation>Liu X, Wen W, Wang T, Tian L, Li N, Sun T, Wang T, Zhou H, Zhang N, Qu P, Mol BW, Li W, Shi J. Increased versus standard gonadotrophin dosing in predicted poor responders of IVF: an open-label randomized controlled trial. Hum Reprod. 2022 Jul 30;37(8):1806-1815. doi: 10.1093/humrep/deac113.</citation>
      <PMID>35595197</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Northwest Women's and Children's Hospital, Xi'an, Shaanxi</investigator_affiliation>
      <investigator_full_name>He Cai</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <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>Cetrorelix</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06023602
  org study id: 2023-038
  nct id: NCT06023602
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The goal of this clinical trial is to compare the clinical outcomes using different
        cetrorelix acetate in the context of a GnRH antagonist protocol for ovarian stimulation in
        women undergoing IVF or intracytoplasmic sperm injection(ICSI) treatment.The main question it
        aims to answer is whether the biosimilar cetrorelix acetate is non-inferior to the reference
        product in the GnRH antagonist based protocol for women undergoing IVF. Ovarian stimulation
        was achieved by several types of follicle-stimulating hormone(FSH) or by FSH combined with
        luteinizing hormone activity. Daily dose of biosimilar cetrorelix acetate (0.25 mg SC) or
        original cetrorelix acetate (0.25 mg SC) will be administered when the lead follicle was 14
        mm. When more than two follicles reached 17 mm, oocyte maturation was triggered with 250 mcg
        of recombinant human chorionic gonadotropin.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Cumulative live birth rate
  time frame: Through study completion, an average of 18 months
  description: For the first live birth (gestation≥ 24 weeks) in one in vitro fertilization/intracytoplasmic sperm injection egg retrieval cycle (fresh and frozen-thawed embryo transfer cycle)
  arm group label: Biosimilar cetrorelix acetate
  arm group type: Experimental
  arm group label: Reference cetrorelix acetate
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: Biosimilar cetrorelix acetate
  description: biosimilar cetrorelix acetate (0.25 mg SC)
  arm group label: Biosimilar cetrorelix acetate
  intervention type: Drug
  intervention name: Reference cetrorelix acetate
  description: reference cetrorelix acetate (0.25 mg SC)
  arm group label: Reference cetrorelix acetate
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 42 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: HE CAI, Doctor
  phone: +8613581613908
  email: caihe@bjmu.edu.cn
  last name: Juanzi Shi, Doctor
  phone: +18602991568
  email: shijuanziart@126.com
  facility: 
  contact: 
  country: China
  citation: Dovey S, McIntyre K, Jacobson D, Catov J, Wakim A. Is a premature rise in luteinizing hormone in the absence of increased progesterone levels detrimental to pregnancy outcome in GnRH antagonist in vitro fertilization cycles. Fertil Steril. 2011 Sep;96(3):585-9. doi: 10.1016/j.fertnstert.2011.06.042. Epub 2011 Jul 20.
  PMID: 21774931
  citation: Liu X, Wen W, Wang T, Tian L, Li N, Sun T, Wang T, Zhou H, Zhang N, Qu P, Mol BW, Li W, Shi J. Increased versus standard gonadotrophin dosing in predicted poor responders of IVF: an open-label randomized controlled trial. Hum Reprod. 2022 Jul 30;37(8):1806-1815. doi: 10.1093/humrep/deac113.
  PMID: 35595197
  responsible party type: Principal Investigator
  investigator affiliation: Northwest Women's and Children's Hospital, Xi'an, Shaanxi
  investigator full name: He Cai
  investigator title: Principal Investigator
  mesh term: Infertility
  mesh term: Cetrorelix
  sharing ipd: No