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/NCT06005207</url>
    </required_header>
    <id_info>
      <org_study_id>SZ-RIF-P-2023</org_study_id>
      <nct_id>NCT06005207</nct_id>
    </id_info>
    <brief_title>Vaginal Progesterone Improves Clinical Outcomes of RIF Patients</brief_title>
    <official_title>A Single-center Randomized Controlled Trial of Vaginal Progesterone to Improve Clinical Pregnancy Outcomes in Patients With Repeated Implantation Failure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nanjing University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nanjing 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 is a single-center, randomized, controlled prospective study. Those patients with&#xD;
        repeated implantation failure (RIF) who will recieve frozen thawed embryo transfer (FET) are&#xD;
        enrolled in the study. To determine the effect of vaginal progesterone on the clinical&#xD;
        pregnancy outcomes of RIF patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        According to the enrollment and exclusion criteria, the patients were enrolled, and the&#xD;
        subjects were randomly divided into two groups by computer randomization. Group A was the&#xD;
        vaginal progesterone added group (test group). Group B was the regular FET group (control&#xD;
        group).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Embryo implantation rate</measure>
      <time_frame>45 days after embryo transfer</time_frame>
      <description>The proportion of the number of implanted embryos to the total number of transferred embryos is the embryo implantation rate.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Clinical pregnancy rate</measure>
      <time_frame>45 days after embryo transfer</time_frame>
      <description>Clinical pregnancy is defined as the presence of gestational sac observed by ultrasound. The proportion of clinical pregnancy cycles to total FET cycles is the clinical pregnancy rate.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Early pregnancy loss rate</measure>
      <time_frame>12 weeks after embryo transfer</time_frame>
      <description>The early pregnancy loss rate refers to the proportion of patients with pregnancy loss before 12 weeks of gestation in the total clinical pregnancy patients.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Persistent pregnancy rate</measure>
      <time_frame>20 weeks after embryo transfer</time_frame>
      <description>The ratio of the number of pregnancies lasting to 20 weeks to the number of transplant cycles.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Live birth rate</measure>
      <time_frame>40 weeks after embryo transfer</time_frame>
      <description>The ratio of the number of live fetal delivery cycles to the number of transplantation cycles after 28 weeks of pregnancy.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">152</enrollment>
    <condition>Infertility, Female</condition>
    <arm_group>
      <arm_group_label>Vaginal progesterone supplementation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>90 mg progesterone vaginal sustained-release gel is added daily to induce endometrial transformation and luteal support</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Regular progesterone</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>No additional vaginal progesterone gel, routine endometrial transformation and luteal support drugs</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>progesterone vaginal sustained-release gel</intervention_name>
      <description>90 mg progesterone vaginal sustained-release gel is added daily during endometrial transformation and luteal support</description>
      <arm_group_label>Vaginal progesterone supplementation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Aged between 20 and 40 years old;&#xD;
  &#xD;
            2. BMI: 18-28 kg/m2；&#xD;
  &#xD;
            3. Consistent with the diagnosis of repeated implantation failure of unknown reasons, the&#xD;
               previous embryo transfer situation meets one of the following:&#xD;
  &#xD;
               Total embryos transferred ≥ 4 high-quality cleavage-stage embryos; ≥ 2 blastocysts; ≥&#xD;
               2 high quality cleavage-stage embryos +≥ 1 blastocysts;&#xD;
  &#xD;
            4. At least 1 high-quality embryo remained for embryo transfer;&#xD;
  &#xD;
            5. Volunteer to participate in the study and sign the informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with recurrent pregnancy loss (≥ 2 biochemical pregnancies or ≥ 2 spontaneous&#xD;
               abortions);&#xD;
  &#xD;
            2. Adverse pregnancy history (stillbirth, fetal malformation, etc.);&#xD;
  &#xD;
            3. Severe paternal factors: need for TESA or PESA;&#xD;
  &#xD;
            4. PGT;&#xD;
  &#xD;
            5. Failure of embryo implantation due to any definite reason, including but not limited&#xD;
               to: endometrial adhesion (moderate to severe), thin endometrium (&lt;7 mm before&#xD;
               transformation), endometritis, endometriosis (medium or severe), adenomyosis,&#xD;
               untreated hydrosalpinx, hysteromyoma (submucosal fibroids, non submucosal fibroids &gt;&#xD;
               4.0 cm and/or endometrial compression), reproductive malformation, serious immune&#xD;
               disease, serious coagulation function abnormality;&#xD;
  &#xD;
            6. Chromosome abnormality of either spouse;&#xD;
  &#xD;
            7. Those with contraindications to pregnancy or assisted reproductive technology.&#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>Chenyang Huang</last_name>
      <phone>+862583107188</phone>
      <email>dianshui19901562@126.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Na Kong</last_name>
      <phone>+862583107188</phone>
      <email>xtalkn@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210008</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chenyang Huang</last_name>
        <phone>+86 25 8310 7188</phone>
        <email>dianshui19901562@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 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 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Nanjing University</investigator_affiliation>
      <investigator_full_name>Li-jun Ding</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>
      <mesh_term>Infertility, Female</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Progesterone</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06005207
  org study id: SZ-RIF-P-2023
  nct id: NCT06005207
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is a single-center, randomized, controlled prospective study. Those patients with
        repeated implantation failure (RIF) who will recieve frozen thawed embryo transfer (FET) are
        enrolled in the study. To determine the effect of vaginal progesterone on the clinical
        pregnancy outcomes of RIF patients.
  According to the enrollment and exclusion criteria, the patients were enrolled, and the
        subjects were randomly divided into two groups by computer randomization. Group A was the
        vaginal progesterone added group (test group). Group B was the regular FET group (control
        group).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Embryo implantation rate
  time frame: 45 days after embryo transfer
  description: The proportion of the number of implanted embryos to the total number of transferred embryos is the embryo implantation rate.
  measure: Clinical pregnancy rate
  time frame: 45 days after embryo transfer
  description: Clinical pregnancy is defined as the presence of gestational sac observed by ultrasound. The proportion of clinical pregnancy cycles to total FET cycles is the clinical pregnancy rate.
  measure: Early pregnancy loss rate
  time frame: 12 weeks after embryo transfer
  description: The early pregnancy loss rate refers to the proportion of patients with pregnancy loss before 12 weeks of gestation in the total clinical pregnancy patients.
  measure: Persistent pregnancy rate
  time frame: 20 weeks after embryo transfer
  description: The ratio of the number of pregnancies lasting to 20 weeks to the number of transplant cycles.
  measure: Live birth rate
  time frame: 40 weeks after embryo transfer
  description: The ratio of the number of live fetal delivery cycles to the number of transplantation cycles after 28 weeks of pregnancy.
  arm group label: Vaginal progesterone supplementation
  arm group type: Experimental
  description: 90 mg progesterone vaginal sustained-release gel is added daily to induce endometrial transformation and luteal support
  arm group label: Regular progesterone
  arm group type: No Intervention
  description: No additional vaginal progesterone gel, routine endometrial transformation and luteal support drugs
  intervention type: Drug
  intervention name: progesterone vaginal sustained-release gel
  description: 90 mg progesterone vaginal sustained-release gel is added daily during endometrial transformation and luteal support
  arm group label: Vaginal progesterone supplementation
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Chenyang Huang
  phone: +862583107188
  email: dianshui19901562@126.com
  last name: Na Kong
  phone: +862583107188
  email: xtalkn@163.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Nanjing University
  investigator full name: Li-jun Ding
  investigator title: principal investigator
  mesh term: Infertility
  mesh term: Infertility, Female
  mesh term: Progesterone