<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/NCT03033277</url>
  </required_header>
  <id_info>
    <org_study_id>Multi-cited POI Recovery</org_study_id>
    <nct_id>NCT03033277</nct_id>
  </id_info>
  <brief_title>Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)</brief_title>
  <official_title>Human Umbilical Cord Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Women With Primary Ovarian Insufficiency (POI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese Academy of Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Third Affiliated Hospital of Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chinese Academy of Sciences</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>
      There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). One of&#xD;
      the most common treatments for POI is hormone replacement therapy (HRT), but HRT doesn't work&#xD;
      well, and it has been shown to increase the risk of blood clots in the veins, ovarian cancer,&#xD;
      and breast cancer. The ability of MSCs to differentiate into oocyte-like cells has been&#xD;
      previously documented. Herein the purpose of this work is to evaluate the therapeutic&#xD;
      potential of cell therapy in women suffering from POI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 2016</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">April 2017</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of mature follicle</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>The number of mature follicles developing was recorded by transvaginal ultrasound scan</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Follicle-stimulating hormone (FSH) serum level</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Serum FSH level was evaluated once a month after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estradiol (E2) serum level</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Serum E2 level was evaluated once a month after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-Mullerian hormone (AMH) serum level</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>Serum AMH level was evaluated once a month after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of antral follicle development</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>The number of antral follicles developing was recorded by transvaginal ultrasound scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ovarian volume</measure>
    <time_frame>Up to 4 months</time_frame>
    <description>The ovarian volume was recorded by transvaginal ultrasound scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy rate</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>The incidence of pregnancy following transfer of embryos produced from oocytes recovered from follicles developing was assessed by Serum Human Chorionic Gonadotropin (HCG) detection.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">320</enrollment>
  <condition>Primary Ovarian Insufficiency</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Hormone replacement therapy, placebo transplantation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hormone replacement therapy,HUC-MSCs transplantation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo transplantation</intervention_name>
    <description>Intraovarian injection of placebo through vagina under the guidance of ultrasonic.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>HUC-MSCs transplantation</intervention_name>
    <description>Intraovarian injection of HUC-MSCs through vagina under the guidance of ultrasonic.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosed with primary ovarian insufficiency;&#xD;
&#xD;
          2. Women between 20 and 40 years;&#xD;
&#xD;
          3. Have fertility requirements, husband has sperm;&#xD;
&#xD;
          4. Willing to sign the Informed Consent Form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Primary amenorrhea;&#xD;
&#xD;
          2. Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome);&#xD;
&#xD;
          3. Thyroid dysfunction;&#xD;
&#xD;
          4. Severe endometriosis;&#xD;
&#xD;
          5. Contraindications for pregnancy;&#xD;
&#xD;
          6. Prior personal history of ovarian cancer;&#xD;
&#xD;
          7. Unwilling to comply with follow-up schedule or want to take other treatment during the&#xD;
             follow-up period;&#xD;
&#xD;
          8. History of serious drug allergy or allergic constitution;&#xD;
&#xD;
          9. Autoimmune disease, history of severe familial genetic disease;&#xD;
&#xD;
         10. HIV+, hepatitis B, C;&#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>Hongmei Wang, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>State Key Laboratory of Stem Cell and Reproductive Biology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Long Yan, Doctor</last_name>
    <phone>+86-15650717331</phone>
    <email>yanlong@ioz.ac.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jianqiao Liu, Doctor</last_name>
    <phone>+86-18928916736</phone>
    <email>ljq88gz@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institute of Zoology, Chinese Academy of Sciences.</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100101</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianqiao Liu, Doctor</last_name>
      <phone>+86-18928916736</phone>
      <email>ljq88gz@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Yixuan Wu, Doctor</last_name>
      <phone>+86-13430202696</phone>
      <email>87295667@qq.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 24, 2017</last_update_submitted>
  <last_update_submitted_qc>January 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese Academy of Sciences</investigator_affiliation>
    <investigator_full_name>Hongmei Wang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Primary Ovarian Insufficiency</mesh_term>
    <mesh_term>Menopause, Premature</mesh_term>
  </condition_browse>
  <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/NCT03033277
org study id: Multi-cited POI Recovery
nct id: NCT03033277
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
There is a high incidence of women suffering from Primary Ovarian Insufficiency (POI). One of
      the most common treatments for POI is hormone replacement therapy (HRT), but HRT doesn't work
      well, and it has been shown to increase the risk of blood clots in the veins, ovarian cancer,
      and breast cancer. The ability of MSCs to differentiate into oocyte-like cells has been
      previously documented. Herein the purpose of this work is to evaluate the therapeutic
      potential of cell therapy in women suffering from POI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Number of mature follicle
time frame: Up to 4 months
description: The number of mature follicles developing was recorded by transvaginal ultrasound scan
measure: Follicle-stimulating hormone (FSH) serum level
time frame: Up to 4 months
description: Serum FSH level was evaluated once a month after surgery
measure: Estradiol (E2) serum level
time frame: Up to 4 months
description: Serum E2 level was evaluated once a month after surgery
measure: Anti-Mullerian hormone (AMH) serum level
time frame: Up to 4 months
description: Serum AMH level was evaluated once a month after surgery
measure: Number of antral follicle development
time frame: Up to 4 months
description: The number of antral follicles developing was recorded by transvaginal ultrasound scan
measure: Ovarian volume
time frame: Up to 4 months
description: The ovarian volume was recorded by transvaginal ultrasound scan
measure: Pregnancy rate
time frame: Up to 12 months
description: The incidence of pregnancy following transfer of embryos produced from oocytes recovered from follicles developing was assessed by Serum Human Chorionic Gonadotropin (HCG) detection.
arm group label: Control group
arm group type: Placebo Comparator
description: Hormone replacement therapy, placebo transplantation.
arm group label: Experimental group
arm group type: Experimental
description: Hormone replacement therapy,HUC-MSCs transplantation.
intervention type: Biological
intervention name: Placebo transplantation
description: Intraovarian injection of placebo through vagina under the guidance of ultrasonic.
arm group label: Control group
intervention type: Biological
intervention name: HUC-MSCs transplantation
description: Intraovarian injection of HUC-MSCs through vagina under the guidance of ultrasonic.
arm group label: Experimental group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: Hongmei Wang, Doctor
role: Principal Investigator
affiliation: State Key Laboratory of Stem Cell and Reproductive Biology
last name: Long Yan, Doctor
phone: +86-15650717331
email: yanlong@ioz.ac.cn
last name: Jianqiao Liu, Doctor
phone: +86-18928916736
email: ljq88gz@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese Academy of Sciences
investigator full name: Hongmei Wang
investigator title: Professor
mesh term: Primary Ovarian Insufficiency
mesh term: Menopause, Premature
sharing ipd: No