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/NCT05998421</url>
    </required_header>
    <id_info>
      <org_study_id>2023003</org_study_id>
      <nct_id>NCT05998421</nct_id>
    </id_info>
    <brief_title>The Effects of Acupuncture on the Natural Pregnancy in Patients With Recurrent Abortion</brief_title>
    <official_title>The Effects of Acupuncture on the Natural Pregnancy in Patients With Recurrent Abortion: a Randomized Prospective Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jianmei Xia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>First People's Hospital of Hangzhou</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>
        Recurrent spontaneous abortion (RSA) is a common pregnancy complication in women of&#xD;
        reproductive age and the cause of RSA remains largely unclear. Acupuncture is widely used in&#xD;
        clinical practice to treat infertility and abortion. The role of acupuncture in the treatment&#xD;
        of infertility is still unclear. The investigators conducted a randomized, prospective,&#xD;
        controlled clinical trial to investigate its potential impact on pregnancy outcome. Herein,&#xD;
        the investigators not only evaluated the changes in patients' psychological stress before and&#xD;
        after treatment but also followed up on pregnancy outcomes. In addition, changes in uterine&#xD;
        artery blood flow were observed by ultrasound. Changes in coagulation-related indicators were&#xD;
        also detected.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        To better illustrate the effectiveness and mechanism of acupuncture in infertility,&#xD;
        especially in RSA patients, the investigators conducted a randomized, prospective, controlled&#xD;
        clinical trial to investigate its potential impact on pregnancy outcome. Herein, the&#xD;
        investigators not only evaluated the changes in patients' psychological stress before and&#xD;
        after treatment but also followed up on pregnancy outcomes. In addition, changes in uterine&#xD;
        artery blood flow were observed by ultrasound. Changes in coagulation-related indicators were&#xD;
        also detected. The investigators hypothesized that acupuncture could promote and improve&#xD;
        pregnancy by improving uterine artery blood flow and relieving patients' anxiety symptoms. To&#xD;
        our knowledge, it has never been reported before.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2022</start_date>
    <completion_date type="Actual">July 29, 2023</completion_date>
    <primary_completion_date type="Actual">March 1, 2023</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, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The effect of acupuncture on pregnancy outcome in patients with recurrent spontaneous abortion</measure>
      <time_frame>average of 1 year</time_frame>
      <description>The pregnancy outcome of each patient was followed-up. The outcomes of natural pregnancy include normal clinical pregnancy(intrauterine pregnancy and pregnancy week ≥28) and adverse pregnancy. The latter includes biochemical pregnancy, spontaneous abortion and ectopic gestation.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of blood indicators related to blood coagulation function after acupuncture1</measure>
      <time_frame>average of half of a year</time_frame>
      <description>Changes in blood indicators related to blood coagulation function, such as platelet maximum aggregation rate (MAR, inducted by arachidonic acid (AA) and adenosine diphosphate (ADP)), were also detected before and after treatment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The effect of acupuncture on blood flow impedance in the uterine arteries before and after each treatment cycle</measure>
      <time_frame>average of half of a year</time_frame>
      <description>Patients in both groups were scheduled for vaginal ultrasound in the mid luteal phase to monitor the blood flow impedance in the uterine arteries before and after each treatment cycle, measured as the uterine artery (UA) systolic/diastolic (S/D) blood flow ratio.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The effect of acupuncture on patients' mental anxiety status before and after each treatment cycle</measure>
      <time_frame>average of half of a year</time_frame>
      <description>Generalized anxiety disorder (GAD-7) was used to assess patients' mental anxiety status. Each item has a score of 0-3, totaling 7 items, with a total score of 0-21. The higher the score, the more severe it becomes.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of blood indicators related to blood coagulation function after acupuncture2</measure>
      <time_frame>average of half of a year</time_frame>
      <description>Changes in blood indicators related to blood coagulation function, such as D-dimer (D-D)were also detected before and after treatment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The change of blood indicators related to blood coagulation function after acupuncture3</measure>
      <time_frame>average of half of a year</time_frame>
      <description>Changes in blood indicators related to blood coagulation function, such as prothrombin time (PT) and activated partial thromboplastin time (APTT), were also detected before and after treatment.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">46</enrollment>
    <condition>Acupuncture</condition>
    <condition>Recurrent Spontaneous Abortion</condition>
    <condition>Ultrasound Therapy</condition>
    <condition>Coagulation</condition>
    <arm_group>
      <arm_group_label>the drug group (control group)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The patients in the control group accepted routine aspirin and heparin treatment. Two months before pregnancy, 50 mg of aspirin (Chenxin Pharmaceutical, China) was taken orally once a day.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>the drug-accompanied-by-acupuncture group (acupuncture group)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The patients in the acupuncture group accepted acupuncture treatment weekly from the second day of menstruation and three times in one cycle.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>acupuncture</intervention_name>
      <description>The patients in the acupuncture group accepted acupuncture treatment weekly from the second day of menstruation and three times in one cycle. Seirin 0.2-×30-mm acupuncture needles were used. First, needles were inserted into Shenting (GV 24) and bilateral Benshen (G 13) to relieve uneasiness of mind. Then, they were inserted into Chung wan (cv 12), Qihai (CV6), Guan yuan, chung chi (cv 3), bilateral Guiai (S 29) and Zigong (Extra 16) to recuperate energy. Finally, bilateral Tsusanli (st 36), Yinlingch'uan (sp 9) and San yin chiao (sp 6) were used to soothe the liver and tonify the spleen and kidney. Each acupuncture treatment session lasted 30 minutes, with mostly bilateral needle retention over 20-30 minutes for evens techniques.</description>
      <arm_group_label>the drug-accompanied-by-acupuncture group (acupuncture group)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>routine aspirin and heparin treatment</intervention_name>
      <description>The patients accepted routine aspirin and heparin treatment. Two months before pregnancy, 50 mg of aspirin (Chenxin Pharmaceutical, China) was taken orally once a day.</description>
      <arm_group_label>the drug group (control group)</arm_group_label>
      <arm_group_label>the drug-accompanied-by-acupuncture group (acupuncture group)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  had a previous RSA history;&#xD;
  &#xD;
            -  had a normal body mass index (BMI) of 18-25 kg/m2;&#xD;
  &#xD;
            -  had no acute infection of the abdomen and low back skin;&#xD;
  &#xD;
            -  had no history of liver or kidney disease.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  acute infection in the abdomen or lower back&#xD;
  &#xD;
            -  planning assisted reproductive technologies (ART) in the next 3 months&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jianmei Xia</last_name>
      <role>Principal Investigator</role>
      <affiliation>First People's Hospital of Hangzhou</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Jianmei Xia</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310006</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>First People's Hospital of Hangzhou</investigator_affiliation>
      <investigator_full_name>Jianmei Xia</investigator_full_name>
      <investigator_title>Deputy Chief Physician</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Abortion, Spontaneous</mesh_term>
      <mesh_term>Abortion, Habitual</mesh_term>
      <mesh_term>Recurrence</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Aspirin</mesh_term>
      <mesh_term>Heparin</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05998421
  org study id: 2023003
  nct id: NCT05998421
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Recurrent spontaneous abortion (RSA) is a common pregnancy complication in women of
        reproductive age and the cause of RSA remains largely unclear. Acupuncture is widely used in
        clinical practice to treat infertility and abortion. The role of acupuncture in the treatment
        of infertility is still unclear. The investigators conducted a randomized, prospective,
        controlled clinical trial to investigate its potential impact on pregnancy outcome. Herein,
        the investigators not only evaluated the changes in patients' psychological stress before and
        after treatment but also followed up on pregnancy outcomes. In addition, changes in uterine
        artery blood flow were observed by ultrasound. Changes in coagulation-related indicators were
        also detected.
  To better illustrate the effectiveness and mechanism of acupuncture in infertility,
        especially in RSA patients, the investigators conducted a randomized, prospective, controlled
        clinical trial to investigate its potential impact on pregnancy outcome. Herein, the
        investigators not only evaluated the changes in patients' psychological stress before and
        after treatment but also followed up on pregnancy outcomes. In addition, changes in uterine
        artery blood flow were observed by ultrasound. Changes in coagulation-related indicators were
        also detected. The investigators hypothesized that acupuncture could promote and improve
        pregnancy by improving uterine artery blood flow and relieving patients' anxiety symptoms. To
        our knowledge, it has never been reported before.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  measure: The effect of acupuncture on pregnancy outcome in patients with recurrent spontaneous abortion
  time frame: average of 1 year
  description: The pregnancy outcome of each patient was followed-up. The outcomes of natural pregnancy include normal clinical pregnancy(intrauterine pregnancy and pregnancy week ≥28) and adverse pregnancy. The latter includes biochemical pregnancy, spontaneous abortion and ectopic gestation.
  measure: The change of blood indicators related to blood coagulation function after acupuncture1
  time frame: average of half of a year
  description: Changes in blood indicators related to blood coagulation function, such as platelet maximum aggregation rate (MAR, inducted by arachidonic acid (AA) and adenosine diphosphate (ADP)), were also detected before and after treatment.
  measure: The effect of acupuncture on blood flow impedance in the uterine arteries before and after each treatment cycle
  time frame: average of half of a year
  description: Patients in both groups were scheduled for vaginal ultrasound in the mid luteal phase to monitor the blood flow impedance in the uterine arteries before and after each treatment cycle, measured as the uterine artery (UA) systolic/diastolic (S/D) blood flow ratio.
  measure: The effect of acupuncture on patients' mental anxiety status before and after each treatment cycle
  time frame: average of half of a year
  description: Generalized anxiety disorder (GAD-7) was used to assess patients' mental anxiety status. Each item has a score of 0-3, totaling 7 items, with a total score of 0-21. The higher the score, the more severe it becomes.
  measure: The change of blood indicators related to blood coagulation function after acupuncture2
  time frame: average of half of a year
  description: Changes in blood indicators related to blood coagulation function, such as D-dimer (D-D)were also detected before and after treatment.
  measure: The change of blood indicators related to blood coagulation function after acupuncture3
  time frame: average of half of a year
  description: Changes in blood indicators related to blood coagulation function, such as prothrombin time (PT) and activated partial thromboplastin time (APTT), were also detected before and after treatment.
  arm group label: the drug group (control group)
  arm group type: Active Comparator
  description: The patients in the control group accepted routine aspirin and heparin treatment. Two months before pregnancy, 50 mg of aspirin (Chenxin Pharmaceutical, China) was taken orally once a day.
  arm group label: the drug-accompanied-by-acupuncture group (acupuncture group)
  arm group type: Experimental
  description: The patients in the acupuncture group accepted acupuncture treatment weekly from the second day of menstruation and three times in one cycle.
  intervention type: Procedure
  intervention name: acupuncture
  description: The patients in the acupuncture group accepted acupuncture treatment weekly from the second day of menstruation and three times in one cycle. Seirin 0.2-×30-mm acupuncture needles were used. First, needles were inserted into Shenting (GV 24) and bilateral Benshen (G 13) to relieve uneasiness of mind. Then, they were inserted into Chung wan (cv 12), Qihai (CV6), Guan yuan, chung chi (cv 3), bilateral Guiai (S 29) and Zigong (Extra 16) to recuperate energy. Finally, bilateral Tsusanli (st 36), Yinlingch'uan (sp 9) and San yin chiao (sp 6) were used to soothe the liver and tonify the spleen and kidney. Each acupuncture treatment session lasted 30 minutes, with mostly bilateral needle retention over 20-30 minutes for evens techniques.
  arm group label: the drug-accompanied-by-acupuncture group (acupuncture group)
  intervention type: Drug
  intervention name: routine aspirin and heparin treatment
  description: The patients accepted routine aspirin and heparin treatment. Two months before pregnancy, 50 mg of aspirin (Chenxin Pharmaceutical, China) was taken orally once a day.
  arm group label: the drug group (control group)
  arm group label: the drug-accompanied-by-acupuncture group (acupuncture group)
  criteria: 
  gender: Female
  minimum age: 25 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Jianmei Xia
  role: Principal Investigator
  affiliation: First People's Hospital of Hangzhou
  facility: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: First People's Hospital of Hangzhou
  investigator full name: Jianmei Xia
  investigator title: Deputy Chief Physician
  mesh term: Abortion, Spontaneous
  mesh term: Abortion, Habitual
  mesh term: Recurrence
  mesh term: Aspirin
  mesh term: Heparin
  sharing ipd: No