<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/NCT03830697</url>
  </required_header>
  <id_info>
    <org_study_id>2018-11-29</org_study_id>
    <nct_id>NCT03830697</nct_id>
  </id_info>
  <brief_title>A Trial Study on Acupuncture Treatment of Poor Ovarian Response</brief_title>
  <official_title>The Trial Was Completed by Shaanxi Provincial Hospital of Traditional Chinese Medicine and Northwest Women and Children's Hospital. Thirty-five Patients With POR Who Underwent ART (Assisted Reproductive) Treatment Were Observed in Each Center. Patients in the Experimental Group Were Given Acupuncture Treatment for 12 Weeks Prior to COH. If the Patient Has a Good COH Timing During Acupuncture Treatment, She Will Enter the COH Cycle at Any Time. Patients in the Control Group Waiting for 12 Weeks Before COH</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shaanxi Hospital of Traditional Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Northwest Women's and Children's Hospital, Xi'an, Shaanxi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shaanxi Hospital of Traditional Chinese Medicine</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>
      The trial was completed by Shaanxi Provincial Hospital of Traditional Chinese Medicine and&#xD;
      Northwest Women and Children's Hospital. Thirty-five patients with POR who underwent ART&#xD;
      (Assisted Reproductive) treatment were observed in each center. Patients in the experimental&#xD;
      group were given acupuncture treatment for 12 weeks prior to COH. If the patient has a good&#xD;
      COH timing during acupuncture treatment, she will enter the COH cycle at any time. Patients&#xD;
      in the control group waited for 12 weeks before COH. In this study, the COH regimen of the&#xD;
      two groups of patients was the same, and the appropriate ovulation induction protocol was&#xD;
      selected by the investigator according to the B-ultrasound and endocrine conditions of the&#xD;
      patient's menstrual day 1-3. At the end of treatment, patients were observed for the number&#xD;
      of eggs in the COH cycle, fertilization rate, cleavage rate, available embryo rate, high&#xD;
      quality embryo rate, implantation rate, ovarian reserve function assessment, menstrual status&#xD;
      and peri-menopausal symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1.Acupuncture intervention&#xD;
&#xD;
        1. test group Patients in the experimental group were given acupuncture treatment for 12&#xD;
           weeks prior to COH. If the patient has a good COH timing during acupuncture treatment,&#xD;
           he or she will enter the COH cycle at any time.&#xD;
&#xD;
           The acupuncture intervention program of the test group is as follows:&#xD;
&#xD;
           Acupoint group 1: Baihui（DU20）, Zhongwan（RN12）, Tianshu （ST25）(bilateral),&#xD;
           Guanyuan（RN4）, uterus (bilateral)（EX-CA1）, Dahe（KI12） (bilateral),Zusanli&#xD;
           （ST36）(bilateral), Sanyinjiao（SP6） (bilateral), Taichong （LR3）(both sides) Acupoint&#xD;
           group 2： Baihui（DU20）,ShenShu（BL23）、ZhongLiao（BL33）、TaiXi（KI3） Operation: The two-point&#xD;
           group was used alternately, with the group 1 as the initial treatment. The patient took&#xD;
           the appropriate position (point group 1 was taken in the supine position, group 2 was&#xD;
           taken in the prone position), and the local skin of the acupoint was routinely&#xD;
           disinfected. Baihui, flat thorn 0.5-1.0 inch; Tai Chong, acupuncture 0.5-1.0 inch in the&#xD;
           direction of Yongquan; Shenshu, Taixi, straight thorn 0.5-1.0 inch; ZhongLiao（BL33） ,&#xD;
           inward and downward oblique thorn 2.0-2.5 inch, It is required to puncture the hole in&#xD;
           the second hole; the remaining hole is straight 1.0-1.5 inch. All the acupoints are&#xD;
           evenly inserted and twisted (the Baihui acupoints only turn around). Each time the&#xD;
           needle is kept for 20 minutes, once every other day, 3 times a week for a total of 12&#xD;
           weeks.&#xD;
&#xD;
        2. Control group Patients in the control group waited for 12 weeks before COH。&#xD;
&#xD;
      2.Standard IVF/ICSI Process&#xD;
&#xD;
        1. COH process（In this study, the COH regimen was the same in both groups, and the&#xD;
           investigator chose the antagonist regimen based on the B-ultrasound and endocrine&#xD;
           conditions on the 1-3 day of menstruation.） 1）Gn start time: Menstruation Day3 days,&#xD;
           B-ultrasound and hormone levels (FSH/LH/E2/P/β-HCG) suggest that the ovary is in a basal&#xD;
           state; 2）Gn starting dose: 75~300 IU; 3）Gn dose adjustment: 5 days after administration,&#xD;
           according to ovarian response (B-ultrasound and E2 levels) Whole Gn dose, hMG (Hemeiqi)&#xD;
           can be added if necessary; 1 ovarian response is monitored every 1~2 days thereafter&#xD;
           (B-ultrasound and E2 level), adjust the amount of Gn accordingly。 4）When the antagonist&#xD;
           is added: when the dominant follicle is ≥12mm, add antagonist (Eugly) 250ug/d to HCG day&#xD;
           (including HCG day); 5）HCG trigger timing and dose: at least 3 follicles ≥ 18mm, given&#xD;
           HCG4000~8000IUim.&#xD;
&#xD;
        2. Eggs taken 36 hours after intramuscular injection of HCG:&#xD;
&#xD;
        3. In vitro fertilization, embryo culture:In vitro fertilization was performed 4 to 6 hours&#xD;
           after egg retrieval, and Day 3 embryos were scored according to the general standards of&#xD;
           each center.The two embryos with the highest score were labeled as the embryos of the&#xD;
           first embryo transfer. The remaining embryos are often Freeze on Day3, Day5 or Day6.&#xD;
&#xD;
        4. Embryo transfer and corpus luteum support：On Day 3, the patient maintained bladder&#xD;
           filling and transplanted 2 of the best quality under the guidance of transabdominal&#xD;
           B-ultrasound.Embryo; or on day 5, under the guidance of transabdominal B-ultrasound,&#xD;
           transplant 1-2 blastocysts; continue to gestrinone 20mg Bid po supports the corpus&#xD;
           luteum.&#xD;
&#xD;
        5. Pregnancy test： 1）Determination of blood βHCG levels 14 days after ET or Cryopreserved&#xD;
           embryo transfer (CET) to determine biochemical pregnancy; 2）If determined to be&#xD;
           pregnant, continue corpus luteum support。 3）35 days after ET, determine the clinical&#xD;
           pregnancy by transvaginal B-ultrasound, record the number of gestational sacs, location,&#xD;
           large Small, the presence or absence of fetal buds, the presence or absence of fetal&#xD;
           heart, other abnormal conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 28, 2021</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of eggs obtained in the COH cycle.</measure>
    <time_frame>After an average of 13 days in the COH cycle</time_frame>
    <description>The number of eggs obtained in the controlled ovarian hyperstimulation cycle.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ovarian reserve function assessment</measure>
    <time_frame>12 week</time_frame>
    <description>Basal sinus follicle count AFC, AMH and basal hormone levels (package)Including FSH, LH and E2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chinese Medicine Symptoms Scoring Standard for Menstruation</measure>
    <time_frame>12 week</time_frame>
    <description>Menstrual situation:Mainly assess the menstrual cycle and menstrual flow. menstrual cycle is based on the results of the patient's own comparison.Divided into normal cycle, early menstruation (&gt;7 days before menstruation) and delayed menstruation (&gt;7 days after menstruation) 3class. According to the patient's own comparison results, the menstrual volume is divided into normal menstruation and less menstrual flow.Reduce, or the menstrual period is less than 2 days, or even a drop. It is generally believed that the amount of menstruation is less than 20ml for less menstruation.Class 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-RatingAnxietyScale</measure>
    <time_frame>12 week</time_frame>
    <description>Menstrual disorders, less menstrual flow, hot flashes, night sweats or cold, convulsions, forgetfulness, irritability Insomnia, secondary symptoms include dizziness, tinnitus, dull complexion, waist and knee pain, itchy skin, low libido.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Poor Ovarian Response</condition>
  <arm_group>
    <arm_group_label>Menstruation situation TCM symptom score standard</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham intervention</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupuncture intervention</intervention_name>
    <description>Patients in the experimental group were given acupuncture treatment for 12 weeks prior to COH. If the patient has a good COH timing during acupuncture treatment, he or she will enter the COH cycle at any time.The acupuncture intervention program of the test group is as follows:Acupoint group 1: Baihui（DU20）, Zhongyu（RN12）, Tianshu （ST25）(bilateral), Guanyuan（RN4）, uterus (bilateral)（EX-CA1）, Dahe（KI12） (bilateral),Zusanli （ST36）(bilateral), Sanyinjiao（SP6） (bilateral), Taichong （LR3）(both sides).</description>
    <arm_group_label>Menstruation situation TCM symptom score standard</arm_group_label>
    <arm_group_label>Sham intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. POR compliant diagnostic criteria&#xD;
&#xD;
          2. Intracytoplasmic sperm injection, ICSI）。 Indication with IVF or intracytoplasmic sperm&#xD;
             injection (ICSI).&#xD;
&#xD;
        3.18≤age&lt;40&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Repeated spontaneous abortion 2 or more patients (including biochemical pregnancy&#xD;
             abortion.&#xD;
&#xD;
          2. Patients who have failed to undergo repeated implantation (at least 3 transplanted&#xD;
             transplants, at least 3-6 high-quality embryos without clinical pregnancy);&#xD;
&#xD;
          3. uterine malformation (single uterus, double uterus, double uterus, untreated&#xD;
             mediastinal uterus) and other effects affecting uterine cavity disease (adenomyosis,&#xD;
             submucosal uterine fibroids, intrauterine adhesions and scar uterus) Patient;&#xD;
&#xD;
          4. Patients and their husbands with abnormal karyotypes (excluding chromosomal&#xD;
             polymorphisms;&#xD;
&#xD;
          5. Untreated patients with hydrosalpinx;&#xD;
&#xD;
          6. (6)Patients with contraindications to ART and pregnancy, or those with a clear&#xD;
             influence on pregnancy, such as hypertension, clinically symptomatic heart disease,&#xD;
             diabetes, liver disease, kidney disease, severe anemia, history of venous thrombosis,&#xD;
             History of pulmonary embolism or cerebrovascular events, history of malignant tumors;&#xD;
&#xD;
          7. Refusal to sign the informed consent form.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Su Tongsheng</last_name>
    <phone>15929562568</phone>
    <email>chinasuts@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shaanxi Hospital of Traditional Chinese Medicine</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tong sheng Su, M.D.</last_name>
      <phone>008615929562568</phone>
      <email>chinasuts@126.com</email>
    </contact>
    <investigator>
      <last_name>Tong Sheng Su, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>March 20, 2019</last_update_submitted>
  <last_update_submitted_qc>March 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03830697
org study id: 2018-11-29
nct id: NCT03830697
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The trial was completed by Shaanxi Provincial Hospital of Traditional Chinese Medicine and
      Northwest Women and Children's Hospital. Thirty-five patients with POR who underwent ART
      (Assisted Reproductive) treatment were observed in each center. Patients in the experimental
      group were given acupuncture treatment for 12 weeks prior to COH. If the patient has a good
      COH timing during acupuncture treatment, she will enter the COH cycle at any time. Patients
      in the control group waited for 12 weeks before COH. In this study, the COH regimen of the
      two groups of patients was the same, and the appropriate ovulation induction protocol was
      selected by the investigator according to the B-ultrasound and endocrine conditions of the
      patient's menstrual day 1-3. At the end of treatment, patients were observed for the number
      of eggs in the COH cycle, fertilization rate, cleavage rate, available embryo rate, high
      quality embryo rate, implantation rate, ovarian reserve function assessment, menstrual status
      and peri-menopausal symptoms.
1.Acupuncture intervention

        1. test group Patients in the experimental group were given acupuncture treatment for 12
           weeks prior to COH. If the patient has a good COH timing during acupuncture treatment,
           he or she will enter the COH cycle at any time.

           The acupuncture intervention program of the test group is as follows:

           Acupoint group 1: Baihui（DU20）, Zhongwan（RN12）, Tianshu （ST25）(bilateral),
           Guanyuan（RN4）, uterus (bilateral)（EX-CA1）, Dahe（KI12） (bilateral),Zusanli
           （ST36）(bilateral), Sanyinjiao（SP6） (bilateral), Taichong （LR3）(both sides) Acupoint
           group 2： Baihui（DU20）,ShenShu（BL23）、ZhongLiao（BL33）、TaiXi（KI3） Operation: The two-point
           group was used alternately, with the group 1 as the initial treatment. The patient took
           the appropriate position (point group 1 was taken in the supine position, group 2 was
           taken in the prone position), and the local skin of the acupoint was routinely
           disinfected. Baihui, flat thorn 0.5-1.0 inch; Tai Chong, acupuncture 0.5-1.0 inch in the
           direction of Yongquan; Shenshu, Taixi, straight thorn 0.5-1.0 inch; ZhongLiao（BL33） ,
           inward and downward oblique thorn 2.0-2.5 inch, It is required to puncture the hole in
           the second hole; the remaining hole is straight 1.0-1.5 inch. All the acupoints are
           evenly inserted and twisted (the Baihui acupoints only turn around). Each time the
           needle is kept for 20 minutes, once every other day, 3 times a week for a total of 12
           weeks.

        2. Control group Patients in the control group waited for 12 weeks before COH。

      2.Standard IVF/ICSI Process

        1. COH process（In this study, the COH regimen was the same in both groups, and the
           investigator chose the antagonist regimen based on the B-ultrasound and endocrine
           conditions on the 1-3 day of menstruation.） 1）Gn start time: Menstruation Day3 days,
           B-ultrasound and hormone levels (FSH/LH/E2/P/β-HCG) suggest that the ovary is in a basal
           state; 2）Gn starting dose: 75~300 IU; 3）Gn dose adjustment: 5 days after administration,
           according to ovarian response (B-ultrasound and E2 levels) Whole Gn dose, hMG (Hemeiqi)
           can be added if necessary; 1 ovarian response is monitored every 1~2 days thereafter
           (B-ultrasound and E2 level), adjust the amount of Gn accordingly。 4）When the antagonist
           is added: when the dominant follicle is ≥12mm, add antagonist (Eugly) 250ug/d to HCG day
           (including HCG day); 5）HCG trigger timing and dose: at least 3 follicles ≥ 18mm, given
           HCG4000~8000IUim.

        2. Eggs taken 36 hours after intramuscular injection of HCG:

        3. In vitro fertilization, embryo culture:In vitro fertilization was performed 4 to 6 hours
           after egg retrieval, and Day 3 embryos were scored according to the general standards of
           each center.The two embryos with the highest score were labeled as the embryos of the
           first embryo transfer. The remaining embryos are often Freeze on Day3, Day5 or Day6.

        4. Embryo transfer and corpus luteum support：On Day 3, the patient maintained bladder
           filling and transplanted 2 of the best quality under the guidance of transabdominal
           B-ultrasound.Embryo; or on day 5, under the guidance of transabdominal B-ultrasound,
           transplant 1-2 blastocysts; continue to gestrinone 20mg Bid po supports the corpus
           luteum.

        5. Pregnancy test： 1）Determination of blood βHCG levels 14 days after ET or Cryopreserved
           embryo transfer (CET) to determine biochemical pregnancy; 2）If determined to be
           pregnant, continue corpus luteum support。 3）35 days after ET, determine the clinical
           pregnancy by transvaginal B-ultrasound, record the number of gestational sacs, location,
           large Small, the presence or absence of fetal buds, the presence or absence of fetal
           heart, other abnormal conditions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: The number of eggs obtained in the COH cycle.
time frame: After an average of 13 days in the COH cycle
description: The number of eggs obtained in the controlled ovarian hyperstimulation cycle.
measure: Ovarian reserve function assessment
time frame: 12 week
description: Basal sinus follicle count AFC, AMH and basal hormone levels (package)Including FSH, LH and E2)
measure: Chinese Medicine Symptoms Scoring Standard for Menstruation
time frame: 12 week
description: Menstrual situation:Mainly assess the menstrual cycle and menstrual flow. menstrual cycle is based on the results of the patient's own comparison.Divided into normal cycle, early menstruation (>7 days before menstruation) and delayed menstruation (>7 days after menstruation) 3class. According to the patient's own comparison results, the menstrual volume is divided into normal menstruation and less menstrual flow.Reduce, or the menstrual period is less than 2 days, or even a drop. It is generally believed that the amount of menstruation is less than 20ml for less menstruation.Class 2.
measure: Self-RatingAnxietyScale
time frame: 12 week
description: Menstrual disorders, less menstrual flow, hot flashes, night sweats or cold, convulsions, forgetfulness, irritability Insomnia, secondary symptoms include dizziness, tinnitus, dull complexion, waist and knee pain, itchy skin, low libido.
arm group label: Menstruation situation TCM symptom score standard
arm group type: Experimental
arm group label: Sham intervention
arm group type: Placebo Comparator
intervention type: Other
intervention name: Acupuncture intervention
description: Patients in the experimental group were given acupuncture treatment for 12 weeks prior to COH. If the patient has a good COH timing during acupuncture treatment, he or she will enter the COH cycle at any time.The acupuncture intervention program of the test group is as follows:Acupoint group 1: Baihui（DU20）, Zhongyu（RN12）, Tianshu （ST25）(bilateral), Guanyuan（RN4）, uterus (bilateral)（EX-CA1）, Dahe（KI12） (bilateral),Zusanli （ST36）(bilateral), Sanyinjiao（SP6） (bilateral), Taichong （LR3）(both sides).
arm group label: Menstruation situation TCM symptom score standard
arm group label: Sham intervention
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Su Tongsheng
phone: 15929562568
email: chinasuts@126.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor