<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/NCT04497558</url>
  </required_header>
  <id_info>
    <org_study_id>JIAI 2020-07</org_study_id>
    <nct_id>NCT04497558</nct_id>
  </id_info>
  <brief_title>The Clinical Efficiency of Tb-ERA in Chinese RIF Patients</brief_title>
  <official_title>The Clinical Efficiency of Transcriptome-based Endometrial Receptivity Assessment (Tb-ERA) in Chinese Patients With Recurrent Implantation Failure (RIF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ShangHai Ji Ai Genetics &amp; IVF Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ShangHai Ji Ai Genetics &amp; IVF Institute</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      In order to further explore the clinical utility of endometrial receptivity array in patients&#xD;
      with repeated implantation failure, the patients divide into the experimental group or the&#xD;
      control group. In the experimental group, those patients undergo endometrial receptivity&#xD;
      array. In the control group, those patients do not receive any treatment before next cycle of&#xD;
      transfer. In the experimental group, according to the results of endometrial receptivity&#xD;
      array, the transplantation time will be adjusted and retransplantation will be carried out.&#xD;
      Statistical analysis of the two groups of primary endpoint and secondary endpoint are done.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the field of assisted reproduction techonology, there are still 10% of patients with&#xD;
      repeated implantation failure. In order to further explore the clinical utility of&#xD;
      endometrial receptivity array in patients with repeated implantation failure, the patients&#xD;
      divide into the experimental group or the control group. In the experimental group, those&#xD;
      patients undergo endometrial receptivity array. In the control group, those patients do not&#xD;
      receive any treatment before next cycle of transfer. In the experimental group, according to&#xD;
      the results of endometrial receptivity array, the transplantation time will be adjusted and&#xD;
      retransplantation will be carried out. In the control group, no intervention will be&#xD;
      performed. Statistical analysis of the two groups of primary endpoint (clinical pregnancy&#xD;
      rate) and secondary endpoint (endometrial implantation window evaluation results, embryo&#xD;
      implantation rate, biochemical pregnancy rate, early abortion rate, ectopic pregnancy rate)&#xD;
      are done. Through the comparative analysis of clinical outcomes to verify the clinical&#xD;
      efficacy of endometrial receptivity analysis in patients with repeated implant failure, this&#xD;
      method will provide a new treatment for repeated implant failure population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 20, 2020</start_date>
  <completion_date type="Anticipated">August 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2022</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>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>6 months</time_frame>
    <description>Clinical pregnancy rate in patients</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Endometrial implantation window evaluation results</measure>
    <time_frame>6 months</time_frame>
    <description>Endometrial implantation window evaluation results in tested patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Embryo implantation rate</measure>
    <time_frame>6 months</time_frame>
    <description>Embryo implantation rate in patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemical pregnancy rate</measure>
    <time_frame>6 months</time_frame>
    <description>Biochemical pregnancy rate in patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early abortion rate</measure>
    <time_frame>6 months</time_frame>
    <description>Early abortion rate in patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ectopic pregnancy rate</measure>
    <time_frame>6 months</time_frame>
    <description>Ectopic pregnancy rate in patients</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Endometrial Receptivity</condition>
  <condition>Repeated Implantation Failure</condition>
  <arm_group>
    <arm_group_label>ERA group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the experimental group, those patients undergo endometrial receptivity array. According to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In the control group, those patients do not receive any treatment before next cycle of transfer. In the control group, no intervention will be performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Endometrium biopsy</intervention_name>
    <description>In the experimental group, those patients undergo endometrial receptivity array. In the control group, those patients do not receive any treatment before next cycle of transfer. In the experimental group, according to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out. In the control group, no intervention will be performed.</description>
    <arm_group_label>ERA group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. People with unexplained repeated implantation failure (3 or more times of&#xD;
             transplantation, at least 4 or more high-quality embryos failed to conceive).&#xD;
&#xD;
          2. Age: 20-40 years old.&#xD;
&#xD;
          3. BMI: 19 - 24.&#xD;
&#xD;
          4. The thickness of endometrium is more than or equal to 7 mm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known causes of embryo implantation failure, such as infection, reproductive tract&#xD;
             malformation, uterine cavity factors, immune factors, hydrosalpinx, etc.&#xD;
&#xD;
          2. Decreased ovarian function (meet the following at least two criteria: ① 10u / L &lt;&#xD;
             basal follicle stimulating hormone (FSH) &lt; 25U / L, and / or estradiol (E2) &gt;&#xD;
             292.8pmol/l, and / or FSH / LH &gt; 3; ② the number of antral follicles &lt; 5-7 on the&#xD;
             second to third day of menstruation; and (or) antimullerian hormone (AMH) &lt;&#xD;
             0.5-1.1ng/ml.&#xD;
&#xD;
          3. People with genetic history.&#xD;
&#xD;
          4. Those who have done abortion and the histogenetic analysis are positive.&#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_official>
    <last_name>Xiaoxi Sun</last_name>
    <role>Study Chair</role>
    <affiliation>Obstetrics and Gynecology Hospital affiliated to Fudan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wenbi Zhang</last_name>
    <phone>+8602163459977</phone>
    <email>jackeyzhang0905@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>He Li</last_name>
    <phone>+8602163459977</phone>
    <email>lihe198900@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shanghai Ji Ai Genetics &amp; IVF Institute, Obstetrics and Gynecology Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wenbi Zhang, Doctor</last_name>
      <email>jackeyzhang0905@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Ruiz-Alonso M, Blesa D, Diaz-Gimeno P, Gomez E, Fernandez-Sanchez M, Carranza F, Carrera J, Vilella F, Pellicer A, Simon C. The endometrial receptivity array for diagnosis and personalized embryo transfer as a treatment for patients with repeated implantation failure. Fertil Steril. 2013 Sep;100(3):818-24. doi: 10.1016/j.fertnstert.2013.05.004. Epub 2013 Jun 4.</citation>
    <PMID>23756099</PMID>
  </reference>
  <reference>
    <citation>Hashimoto T, Koizumi M, Doshida M, Toya M, Sagara E, Oka N, Nakajo Y, Aono N, Igarashi H, Kyono K. Efficacy of the endometrial receptivity array for repeated implantation failure in Japan: A retrospective, two-centers study. Reprod Med Biol. 2017 Jun 27;16(3):290-296. doi: 10.1002/rmb2.12041. eCollection 2017 Jul.</citation>
    <PMID>29259480</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>August 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>March 31, 2021</last_update_submitted>
  <last_update_submitted_qc>March 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>ShangHai Ji Ai Genetics &amp; IVF Institute</investigator_affiliation>
    <investigator_full_name>Wenbi Zhang</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>endometrial receptivity array</keyword>
  <keyword>Repeated implantation failure</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04497558
org study id: JIAI 2020-07
nct id: NCT04497558
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In order to further explore the clinical utility of endometrial receptivity array in patients
      with repeated implantation failure, the patients divide into the experimental group or the
      control group. In the experimental group, those patients undergo endometrial receptivity
      array. In the control group, those patients do not receive any treatment before next cycle of
      transfer. In the experimental group, according to the results of endometrial receptivity
      array, the transplantation time will be adjusted and retransplantation will be carried out.
      Statistical analysis of the two groups of primary endpoint and secondary endpoint are done.
In the field of assisted reproduction techonology, there are still 10% of patients with
      repeated implantation failure. In order to further explore the clinical utility of
      endometrial receptivity array in patients with repeated implantation failure, the patients
      divide into the experimental group or the control group. In the experimental group, those
      patients undergo endometrial receptivity array. In the control group, those patients do not
      receive any treatment before next cycle of transfer. In the experimental group, according to
      the results of endometrial receptivity array, the transplantation time will be adjusted and
      retransplantation will be carried out. In the control group, no intervention will be
      performed. Statistical analysis of the two groups of primary endpoint (clinical pregnancy
      rate) and secondary endpoint (endometrial implantation window evaluation results, embryo
      implantation rate, biochemical pregnancy rate, early abortion rate, ectopic pregnancy rate)
      are done. Through the comparative analysis of clinical outcomes to verify the clinical
      efficacy of endometrial receptivity analysis in patients with repeated implant failure, this
      method will provide a new treatment for repeated implant failure population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Clinical pregnancy rate
time frame: 6 months
description: Clinical pregnancy rate in patients
measure: Endometrial implantation window evaluation results
time frame: 6 months
description: Endometrial implantation window evaluation results in tested patients
measure: Embryo implantation rate
time frame: 6 months
description: Embryo implantation rate in patients
measure: Biochemical pregnancy rate
time frame: 6 months
description: Biochemical pregnancy rate in patients
measure: Early abortion rate
time frame: 6 months
description: Early abortion rate in patients
measure: Ectopic pregnancy rate
time frame: 6 months
description: Ectopic pregnancy rate in patients
arm group label: ERA group
arm group type: Experimental
description: In the experimental group, those patients undergo endometrial receptivity array. According to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out.
arm group label: Control group
arm group type: No Intervention
description: In the control group, those patients do not receive any treatment before next cycle of transfer. In the control group, no intervention will be performed.
intervention type: Diagnostic Test
intervention name: Endometrium biopsy
description: In the experimental group, those patients undergo endometrial receptivity array. In the control group, those patients do not receive any treatment before next cycle of transfer. In the experimental group, according to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out. In the control group, no intervention will be performed.
arm group label: ERA group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: Xiaoxi Sun
role: Study Chair
affiliation: Obstetrics and Gynecology Hospital affiliated to Fudan University
last name: Wenbi Zhang
phone: +8602163459977
email: jackeyzhang0905@163.com
last name: He Li
phone: +8602163459977
email: lihe198900@163.com
facility: 
status: Recruiting
contact: 
country: China
citation: Ruiz-Alonso M, Blesa D, Diaz-Gimeno P, Gomez E, Fernandez-Sanchez M, Carranza F, Carrera J, Vilella F, Pellicer A, Simon C. The endometrial receptivity array for diagnosis and personalized embryo transfer as a treatment for patients with repeated implantation failure. Fertil Steril. 2013 Sep;100(3):818-24. doi: 10.1016/j.fertnstert.2013.05.004. Epub 2013 Jun 4.
PMID: 23756099
citation: Hashimoto T, Koizumi M, Doshida M, Toya M, Sagara E, Oka N, Nakajo Y, Aono N, Igarashi H, Kyono K. Efficacy of the endometrial receptivity array for repeated implantation failure in Japan: A retrospective, two-centers study. Reprod Med Biol. 2017 Jun 27;16(3):290-296. doi: 10.1002/rmb2.12041. eCollection 2017 Jul.
PMID: 29259480
responsible party type: Principal Investigator
investigator affiliation: ShangHai Ji Ai Genetics & IVF Institute
investigator full name: Wenbi Zhang
investigator title: Clinical Professor
sharing ipd: No