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/NCT05994378</url>
    </required_header>
    <id_info>
      <org_study_id>SHR7280-302</org_study_id>
      <nct_id>NCT05994378</nct_id>
    </id_info>
    <brief_title>To Compare the Efficacy and Safety of Oral SHR 7280 Tablets With Ganirelix Acetate Injection in Infertile Female Subjects</brief_title>
    <official_title>To Compare the Efficacy and Safety of Oral SHR7280 Tablets With Ganirelix Acetate Injection in Female Subjects With Infertility Receiving Controlled Ovarian Hyperstimulation Therapy: A Multi-center, Randomized, Parallel-Group, Double-Blind, Dual-Simulation, Non-Inferiority Phase III Clinical Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jiangsu HengRui Medicine Co., Ltd.</source>
    <oversight_info>
      <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 is a multi-center, randomized, double-blind, positive drug-controlled,&#xD;
        non-inferiority Phase III clinical trial. The study will enroll approximately 316 infertile&#xD;
        female subjects undergoing controlled ovarian hyperstimulation (COH) for in vitro&#xD;
        fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 10, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2024</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of oocyte retrieved per COH cycle</measure>
      <time_frame>On oocyte retrieval 1 day</time_frame>
      <description>number of oocytes obtained after one COH cycle;</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Inhibition rate of premature LH surge</measure>
      <time_frame>the hCG injection 1 day</time_frame>
      <description>premature LH surge is defined as: LH ≥ 10 IU/L and progesterone P ≥ 1 ng/mL (3.18 nmol/L);</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>2PN rate</measure>
      <time_frame>16-18 hours (h) after fertilization</time_frame>
      <description>number of 2 pronuclei(2PN) oocytes/ number of oocytes retrieved or number of MII oocytes×100%;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>High quality embryo rate</measure>
      <time_frame>3 days after fertilization</time_frame>
      <description>number of high-quality embryos/ cleavage number×100%;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Chemical pregnancy rate</measure>
      <time_frame>on chemical pregnancy test 1 day</time_frame>
      <description>number of pregnancy cycles/ number of transplantation cycles×100%;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clinical pregnancy rate</measure>
      <time_frame>on clinical pregnancy test 1 day</time_frame>
      <description>number of clinical pregnancy cycles/ number of transplantation cycles×100%;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Persistent pregnancy rate</measure>
      <time_frame>on persistent pregnancy test 1 day</time_frame>
      <description>number of clinical pregnancy cycles/ number of transplantation cycles×100%;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse drug events</measure>
      <time_frame>Day 1 to persistent pregnancy test day/ or End-of-trial visit 1 day</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">316</enrollment>
    <condition>Infertile Female Subjects Undergoing Controlled Ovarian Hyperstimulation to Suppress Premature LH Surge and Prevent Early Ovulation</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SHR7280；Ganirelix Acetate Injection simulant</intervention_name>
      <description>SHR7280 200mg Q12h and Ganirelix Acetate Injection simulant 0.5mL qd;</description>
      <arm_group_label>Experimental group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SHR7280 simulant； Ganirelix Acetate Injection</intervention_name>
      <description>SHR7280 simulant 200mg Q12h and Ganirelix Acetate Injection 0.5mL:0.25mg qd;</description>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Married infertile female subjects aged 20 to 39 years with indications for in vitro&#xD;
               fertilization-embryo transfer (IVF-ET) or intracytoplasmic sperm injection (ICSI);&#xD;
  &#xD;
            2. Body mass index (BMI) 18 ~ 28kg/m2 (both exclusive) and weight 45Kg ~ 75Kg (both&#xD;
               inclusive);&#xD;
  &#xD;
            3. Regular menstrual cycle (24 ~ 35 days, both inclusive) for the last 3 months prior to&#xD;
               screening;&#xD;
  &#xD;
            4. Anticipated normal ovarian response;&#xD;
  &#xD;
            5. Willingness of the subject to undergo fresh cycle transfer with one or two embryos at&#xD;
               a time in the first IVF-ET cycle；&#xD;
  &#xD;
            6. Normal cervical cytology results (TCT) or with limited clinically significance within&#xD;
               1 year prior to screening or on the screening visit; or subjects with atypical&#xD;
               squamous cells of undetermined significance (ASC-US) of TCT tested negative for&#xD;
               high-risk types of human papillomavirus (HPV);&#xD;
  &#xD;
            7. Informed consent of subjects and their spouses;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Prior to screening, individuals underwent three or more IVF/ICSI-ET COH cycles without&#xD;
               achieving clinical pregnancy；&#xD;
  &#xD;
            2. Previous IVF/ ICSI failure due to sperm/fertilization problems and no improvement in&#xD;
               related medical condition;&#xD;
  &#xD;
            3. Subjects with more than 2 times of spontaneous abortion;&#xD;
  &#xD;
            4. Subjects at high risk of OHSS, judged by the investigator according to the Golan&#xD;
               classification (e.g., those with moderate to severe OHSS during previous COH cycles,&#xD;
               polycystic ovary syndrome (PCOS), or with previous cancelled COH cycles due to OHSS);&#xD;
  &#xD;
            5. Subjects with decreased ovarian reserve;&#xD;
  &#xD;
            6. TSH test result above or equal to 2.5 mIU/L for subjects with prior hypothyroidism or&#xD;
               subclinical hypothyroidism on screening visit;&#xD;
  &#xD;
            7. Any pregnancy that occurred within 3 months prior to screening visit;&#xD;
  &#xD;
            8. Unexplained abnormal vaginal bleeding;&#xD;
  &#xD;
            9. Infectious disease screening indicates any of the following: positive for HIV&#xD;
               antibodies, positive for syphilis spirochete antibodies; positive for Hepatitis C&#xD;
               virus (HCV) antibodies and positive HCV-RNA test; positive for Hepatitis B surface&#xD;
               antigen (HBsAg) and HBV-DNA ≥ 1×103 kIU/L (or IU/mL);&#xD;
  &#xD;
           10. Use of fertility regulators within one month before ovarian stimulation, such as&#xD;
               clomiphene citrate, letrozole, gonadotropins (Gn), metformin, hormonal drugs&#xD;
               (including oral contraceptives, estrogens, progestogens, etc.).&#xD;
  &#xD;
           11. Past medical history or gynecological ultrasound indicates clinically significant&#xD;
               conditions;&#xD;
  &#xD;
           12. ALT and AST levels at the screening visit or the start of ovarian stimulation were&#xD;
               more than twice the upper limit of normal;&#xD;
  &#xD;
           13. Positive serum β-hCG test results on the screening visit or the start day of ovarian&#xD;
               stimulation;&#xD;
  &#xD;
           14. Blood or blood component donation within one month before screening, or a blood loss&#xD;
               equivalent to at least 200 mL, or a blood transfusion within two months;&#xD;
  &#xD;
           15. Severe infection, severe trauma, or major surgery within six months before screening;&#xD;
  &#xD;
           16. Any disease or symptom that can affect systemic function and may affect the&#xD;
               absorption, accumulation, metabolism, or excretion of the test drug (e.g., chronic&#xD;
               intestinal diseases, Crohn's disease, ulcerative colitis).&#xD;
  &#xD;
           17. Major systemic diseases, endocrine or metabolic abnormalities;&#xD;
  &#xD;
           18. Thromboembolic diseases or a history of thromboembolic diseases;&#xD;
  &#xD;
           19. The subject or her spouse requires oocyte or sperm donation, or either or both of them&#xD;
               carry a chromosomal abnormality deemed clinically significant by the researcher, or&#xD;
               suffer from a known monogenic hereditary disease or a severe disease with genetic&#xD;
               susceptibility requiring pre-implantation genetic testing (PGT);&#xD;
  &#xD;
           20. Smoking (more than 5 cigarettes or equivalent tobacco daily) or alcohol abuse&#xD;
               (drinking ≥14 units of alcohol weekly: 1 unit = 360 mL beer, or 25 mL of 40% or higher&#xD;
               spirits, or 1 glass of wine, 180 mL) within three months before screening;&#xD;
  &#xD;
           21. History of drug abuse or drug dependence;&#xD;
  &#xD;
           22. Allergic constitution or allergy to two or more foods or drugs, including a known&#xD;
               allergy to any component of the test drug or non-test drug; contraindication or&#xD;
               allergy to GnRH agonists or GnRH antagonists, recombinant or urinary FSH, hCG,&#xD;
               progesterone drugs;&#xD;
  &#xD;
           23. Participation in any drug or medical device clinical trial within three months before&#xD;
               screening, or still in the follow-up period of a clinical study before screening, or&#xD;
               within the 5 half-lives of the test drug (whichever is longer);&#xD;
  &#xD;
           24. Malignant tumor or history of malignant tumor (except basal cell or squamous cell skin&#xD;
               cancer, in situ cancer), or a high risk of malignant tumor onset/recurrence;&#xD;
  &#xD;
           25. Known history of severe mental illness, or inability to understand the purpose,&#xD;
               methods, etc., of this clinical trial, or non-compliance with research procedures;&#xD;
  &#xD;
           26. Any other reasons deemed by the researcher as unsuitable for participation in this&#xD;
               study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Zeli Li</last_name>
      <phone>+86 0518-82342973</phone>
      <email>zeli.li.zl13@hengrui.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infertility</mesh_term>
      <mesh_term>Ovarian Hyperstimulation Syndrome</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ganirelix</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/NCT05994378
  org study id: SHR7280-302
  nct id: NCT05994378
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is a multi-center, randomized, double-blind, positive drug-controlled,
        non-inferiority Phase III clinical trial. The study will enroll approximately 316 infertile
        female subjects undergoing controlled ovarian hyperstimulation (COH) for in vitro
        fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Number of oocyte retrieved per COH cycle
  time frame: On oocyte retrieval 1 day
  description: number of oocytes obtained after one COH cycle;
  measure: Inhibition rate of premature LH surge
  time frame: the hCG injection 1 day
  description: premature LH surge is defined as: LH ≥ 10 IU/L and progesterone P ≥ 1 ng/mL (3.18 nmol/L);
  measure: 2PN rate
  time frame: 16-18 hours (h) after fertilization
  description: number of 2 pronuclei(2PN) oocytes/ number of oocytes retrieved or number of MII oocytes×100%;
  measure: High quality embryo rate
  time frame: 3 days after fertilization
  description: number of high-quality embryos/ cleavage number×100%;
  measure: Chemical pregnancy rate
  time frame: on chemical pregnancy test 1 day
  description: number of pregnancy cycles/ number of transplantation cycles×100%;
  measure: Clinical pregnancy rate
  time frame: on clinical pregnancy test 1 day
  description: number of clinical pregnancy cycles/ number of transplantation cycles×100%;
  measure: Persistent pregnancy rate
  time frame: on persistent pregnancy test 1 day
  description: number of clinical pregnancy cycles/ number of transplantation cycles×100%;
  measure: Adverse drug events
  time frame: Day 1 to persistent pregnancy test day/ or End-of-trial visit 1 day
  arm group label: Experimental group
  arm group type: Experimental
  arm group label: Control group
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: SHR7280；Ganirelix Acetate Injection simulant
  description: SHR7280 200mg Q12h and Ganirelix Acetate Injection simulant 0.5mL qd;
  arm group label: Experimental group
  intervention type: Drug
  intervention name: SHR7280 simulant； Ganirelix Acetate Injection
  description: SHR7280 simulant 200mg Q12h and Ganirelix Acetate Injection 0.5mL:0.25mg qd;
  arm group label: Control group
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Zeli Li
  phone: +86 0518-82342973
  email: zeli.li.zl13@hengrui.com
  responsible party type: Sponsor
  mesh term: Infertility
  mesh term: Ovarian Hyperstimulation Syndrome
  mesh term: Ganirelix
  sharing ipd: Undecided