<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/NCT02229604</url>
  </required_header>
  <id_info>
    <org_study_id>ZZ0708081</org_study_id>
    <nct_id>NCT02229604</nct_id>
  </id_info>
  <brief_title>Electroacupuncture for Diminished Ovarian Reserve</brief_title>
  <official_title>Electroacupuncture for Diminished Ovarian Reserve-a Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diminished ovarian reserve (DOR)is a disease can not be cured. Medicine for DOR includes&#xD;
      dehydroepiandrosterone (DHEA), hormone replacement therapy (HRT), immunosuppressive agents&#xD;
      and alternative therapy, etc. Electroacupuncture (EA) can help patients regain regular&#xD;
      menses, increase the estradiol (E2) level and decrease the follicle-stimulating hormone (FSH)&#xD;
      and decrease FSH/luteotropic (LH) ratio. In this cohort study, we aim to observe the effect&#xD;
      of EA versus other therapies for DOR.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change of FSH from baseline</measure>
    <time_frame>baseline, week 12</time_frame>
    <description>The follicle-stimulating hormone (FSH) will be tested at baseline and week 12</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change of FSH level from baseline</measure>
    <time_frame>baseline, week 4, 8, 16, 20, and 24</time_frame>
    <description>FSH will be tested at baseline and week 4, 8, 16, 20, and 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in FSH/LH ratio, LH, and E2 from baseline</measure>
    <time_frame>baseline, week 4, 8, 12, 16, 20, and 24</time_frame>
    <description>FSH/LH ratio, LH, and E2 will be tested at baseline and week 4, 8, 12, 16, 20, and 24</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change of symptom scale</measure>
    <time_frame>baseline, week 12, week 24</time_frame>
    <description>Symptoms need to be assessed include irritability and depression. A 4-point scale is used to evaluate the degree of symptoms (0 means &quot;not at all&quot; and 3 means &quot;severe&quot;).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proportion of patients regaining regular menses</measure>
    <time_frame>baseline, weeks 8, 12 and 24</time_frame>
    <description>The proportion of patients regaining regular menses at week8, 12 and 24 will be compared between groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">57</enrollment>
  <condition>Irregular Menses</condition>
  <arm_group>
    <arm_group_label>EA group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients choose this group will receive EA as a combination. Beside of EA, participants could receive oral medicine as the same as that of the drug group. The EA regimen has two point formulae, i.e. A (BL33) and B (ST25, EX-CA1 and RN4). The two formulae will be used alternatively. One session will last for 20 minutes, 5 sessions per week for the first 4 weeks and 3 sessions per week later (44 sessions in all).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>drug group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hormone replacement therapy (HRT), DHEA and herb decoction are allowed to be used for this group. Treatment course is not fixed. Immunosuppressive agents are not allowed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EA</intervention_name>
    <description>For BL33, insert the needle to the third posterior sacral foramina to a depth of 80-100mm. For ST25, EX-CA1 and RN4, the needle will be inserted vertically and quickly through the skin, and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall (until the moment of resistance is sensed on the tip of the needle and the participant feels a sting). The electric stimulator will be put on the BL33 and EX-CA1 with a continuous wave, 20 Hz, 1.0-4.0 mA.</description>
    <arm_group_label>EA group</arm_group_label>
    <other_name>acupuncture</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HRT, DHEA and herb</intervention_name>
    <description>HRT, dehydroepiandrosterone (DHEA) and herb decoction could be used for this group. Time frame of treatment is not fixed. Herb decoction will be given to participants based on the principle of syndrome differentiation (a diagnosing method in Traditional Chinese Medicine).</description>
    <arm_group_label>EA group</arm_group_label>
    <arm_group_label>drug group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age younger than 40 yr&#xD;
&#xD;
          -  10IU/L ≤ FSH ≤ 40IU/L&#xD;
&#xD;
          -  Volunteer to join the research and give the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A history of ovariectomy, receiving cytotoxic chemotherapy or irradiation&#xD;
&#xD;
          -  Reproductive system infection or tumor&#xD;
&#xD;
          -  Autoimmune disease&#xD;
&#xD;
          -  Amenorrhea due to reproduction abnormality or pregnancy&#xD;
&#xD;
          -  Patients can not adhere to treatment due to personal situation&#xD;
&#xD;
          -  Patients have taken immunosuppressive agents in past 6 months&#xD;
&#xD;
          -  receive treatment for less than 1 week before withdrawal&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhishun Liu, Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences</affiliation>
  </overall_official>
  <removed_countries>
    <country>China</country>
  </removed_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>October 6, 2016</last_update_submitted>
  <last_update_submitted_qc>October 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 10, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</investigator_affiliation>
    <investigator_full_name>Liu Zhishun</investigator_full_name>
    <investigator_title>Dean of Acupuncture Department of Guangan'men Hospital</investigator_title>
  </responsible_party>
  <keyword>electroacupuncture</keyword>
  <keyword>diminished ovarian reserve</keyword>
  <keyword>cohort study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Menstruation Disturbances</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02229604
org study id: ZZ0708081
nct id: NCT02229604
lead sponsor: 
has dmc: No
Diminished ovarian reserve (DOR)is a disease can not be cured. Medicine for DOR includes
      dehydroepiandrosterone (DHEA), hormone replacement therapy (HRT), immunosuppressive agents
      and alternative therapy, etc. Electroacupuncture (EA) can help patients regain regular
      menses, increase the estradiol (E2) level and decrease the follicle-stimulating hormone (FSH)
      and decrease FSH/luteotropic (LH) ratio. In this cohort study, we aim to observe the effect
      of EA versus other therapies for DOR.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: change of FSH from baseline
time frame: baseline, week 12
description: The follicle-stimulating hormone (FSH) will be tested at baseline and week 12
measure: change of FSH level from baseline
time frame: baseline, week 4, 8, 16, 20, and 24
description: FSH will be tested at baseline and week 4, 8, 16, 20, and 24
measure: changes in FSH/LH ratio, LH, and E2 from baseline
time frame: baseline, week 4, 8, 12, 16, 20, and 24
description: FSH/LH ratio, LH, and E2 will be tested at baseline and week 4, 8, 12, 16, 20, and 24
measure: change of symptom scale
time frame: baseline, week 12, week 24
description: Symptoms need to be assessed include irritability and depression. A 4-point scale is used to evaluate the degree of symptoms (0 means "not at all" and 3 means "severe").
measure: proportion of patients regaining regular menses
time frame: baseline, weeks 8, 12 and 24
description: The proportion of patients regaining regular menses at week8, 12 and 24 will be compared between groups
arm group label: EA group
arm group type: Experimental
description: Patients choose this group will receive EA as a combination. Beside of EA, participants could receive oral medicine as the same as that of the drug group. The EA regimen has two point formulae, i.e. A (BL33) and B (ST25, EX-CA1 and RN4). The two formulae will be used alternatively. One session will last for 20 minutes, 5 sessions per week for the first 4 weeks and 3 sessions per week later (44 sessions in all).
arm group label: drug group
arm group type: Active Comparator
description: Hormone replacement therapy (HRT), DHEA and herb decoction are allowed to be used for this group. Treatment course is not fixed. Immunosuppressive agents are not allowed.
intervention type: Other
intervention name: EA
description: For BL33, insert the needle to the third posterior sacral foramina to a depth of 80-100mm. For ST25, EX-CA1 and RN4, the needle will be inserted vertically and quickly through the skin, and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall (until the moment of resistance is sensed on the tip of the needle and the participant feels a sting). The electric stimulator will be put on the BL33 and EX-CA1 with a continuous wave, 20 Hz, 1.0-4.0 mA.
arm group label: EA group
other name: acupuncture
intervention type: Drug
intervention name: HRT, DHEA and herb
description: HRT, dehydroepiandrosterone (DHEA) and herb decoction could be used for this group. Time frame of treatment is not fixed. Herb decoction will be given to participants based on the principle of syndrome differentiation (a diagnosing method in Traditional Chinese Medicine).
arm group label: EA group
arm group label: drug group
criteria: 
gender: Female
minimum age: N/A
maximum age: 40 Years
healthy volunteers: No
last name: Zhishun Liu, Ph.D
role: Study Chair
affiliation: Guang'an Men Hospotal Affiliated to China Academy of Chinese Medical Sciences
country: China
responsible party type: Principal Investigator
investigator affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
investigator full name: Liu Zhishun
investigator title: Dean of Acupuncture Department of Guangan'men Hospital
mesh term: Menstruation Disturbances
sharing ipd: Undecided