<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/NCT04407871</url>
  </required_header>
  <id_info>
    <org_study_id>IVFAct</org_study_id>
    <nct_id>NCT04407871</nct_id>
  </id_info>
  <brief_title>Acupuncture and Chinese Herbal Medicine to Improve Live Birth Rate of in Vitro Fertilization (IVFAct)</brief_title>
  <acronym>IVFAct</acronym>
  <official_title>Acupuncture and Chinese Herbal Medicine to Improve Live Birth Rate of in Vitro Fertilization - A Randomized Controlled Trial (IVFAct)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heilongjiang University of Chinese Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heilongjiang University of Chinese Medicine</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>
      The most successful treatment for infertility is in vitro fertilization (IVF), but less than&#xD;
      10% of infertile couples undergo IVF because of the high cost and relatively low success&#xD;
      rate. Many patients have tried complementary and alternative medical treatments as an&#xD;
      adjuvant therapy to improve their IVF success. Acupuncture given 2-4 times around the day of&#xD;
      embryo transfer has not been shown to improve the IVF live birth rate. Chinese Herbal&#xD;
      Medicine (CHM) may improve the IVF pregnancy rates, but the evidence so far is inconclusive&#xD;
      because of high risks of bias in these studies.&#xD;
&#xD;
      The objective of this multi-centre double blind randomized trial is to evaluate the efficacy&#xD;
      of acupuncture with or without CHM on the live birth of IVF. The randomization process will&#xD;
      be coordinated through a central mechanism. A total of 2,728 subjects will be randomized in&#xD;
      1:1:1:1 ratio in to one of the four treatment arms: 1) acupuncture and CHM, 2) acupuncture&#xD;
      and placebo CHM, 3) control acupuncture and CHM or 4) control acupuncture and placebo CHM.&#xD;
      Women will receive acupuncture or control acupuncture three times a week 4 weeks prior to IVF&#xD;
      during ovarian stimulation, and before and after the embryo transfer. They will also take CHM&#xD;
      or placebo CHM daily 4 weeks prior to IVF till a negative pregnancy test or till 8 weeks of&#xD;
      gestation if pregnant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this multi-centre double blind randomized trial is to evaluate the efficacy&#xD;
      of acupuncture with or without CHM on the live birth of IVF. The randomization process will&#xD;
      be coordinated through a central mechanism. A total of 2,728 subjects will be randomized in&#xD;
      1:1:1:1 ratio in to one of the four treatment arms: 1) acupuncture and CHM, 2) acupuncture&#xD;
      and placebo CHM, 3) control acupuncture and CHM or 4) control acupuncture and placebo CHM.&#xD;
      Women will receive acupuncture or control acupuncture three times a week 4 weeks prior to IVF&#xD;
      during ovarian stimulation, and before and after the embryo transfer. They will also take CHM&#xD;
      or placebo CHM daily 4 weeks prior to IVF till a negative pregnancy test or till 8 weeks of&#xD;
      gestation if pregnant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 1, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Live birth</measure>
    <time_frame>≥20 weeks of gestation</time_frame>
    <description>Live birth defined as a delivery ≥20weeks gestation per transfer in the stimulated IVF cycles or in the first frozen-thawed embryo transfer cycle in those with elective freezing of all embryos</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Embryo quality: embryo scoring standard</measure>
    <time_frame>On the third day after egg retrieval and before embryo transfer</time_frame>
    <description>Embryo quality is judged by embryo scoring standard</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Miscarriage rate</measure>
    <time_frame>≤42 weeks of gestation</time_frame>
    <description>Cumulative miscarriage rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implantation rate</measure>
    <time_frame>2 weeks after embryo transfer</time_frame>
    <description>Cumulative implantation rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive serum human chorionic gonadotropin (hCG) level</measure>
    <time_frame>2 weeks after embryo transfer</time_frame>
    <description>Positive serum hCG level 2 weeks after embryo transfer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ongoing pregnancy rate</measure>
    <time_frame>≥8 weeks</time_frame>
    <description>Cumulative ongoing pregnancy rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple pregnancy rate</measure>
    <time_frame>≥2 weeks after embryo transfer</time_frame>
    <description>Cumulative multiple pregnancy rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ectopic pregnancy rate</measure>
    <time_frame>≥2 weeks after embryo transfer</time_frame>
    <description>Cumulative ectopic pregnancy rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative live birth rate</measure>
    <time_frame>within 6 months after randomization</time_frame>
    <description>Cumulative live birth rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in markers of stress, anxiety</measure>
    <time_frame>≤8 weeks of gestation</time_frame>
    <description>To elucidate the anxiety level as measured with serum cortisol concentration and Stait-Trait Anxiety Inventory (STAI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life(HRQoL)</measure>
    <time_frame>≤8 weeks of gestation</time_frame>
    <description>To determine women's health related quality of life (HRQoL) by short-form 36 (SF36)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient acceptability: acupuncture trust score</measure>
    <time_frame>On the day of embryo transfer</time_frame>
    <description>Patient acceptability of acupuncture to be measured by acupuncture trust score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects</measure>
    <time_frame>≤ 8 weeks of gestation</time_frame>
    <description>Side effects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Congenital abnormalities</measure>
    <time_frame>at 6 weeks postpartum</time_frame>
    <description>Judging by prenatal ultrasound and postnatal physical examination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pregnancy complications</measure>
    <time_frame>≤42 weeks of gestation</time_frame>
    <description>Complications of Pregnancy</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">2728</enrollment>
  <condition>In Vitro Fertilization</condition>
  <arm_group>
    <arm_group_label>acupuncture and CHM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women will receive acupuncture three times a week 4 weeks prior to ovarian stimulation for IVF and during ovarian stimulation, and before and after embryo transfer (ET). They will also take CHM daily 4 weeks prior to IVF till the day of serum hCG testing. If the hCG testing is positive and a viable pregnancy is confirmed by transvaginal ultrasound, CHM will be continued till 8 weeks of gestation. If the hCG testing is negative or spontaneous miscarriage is confirmed, the drug treatment will be stopped.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>acupuncture and placebo CHM</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Women will receive acupuncture three times a week 4 weeks prior to ovarian stimulation for IVF and during ovarian stimulation, and before and after ET. They will also take placebo CHM daily 4 weeks prior to IVF till the day of serum hCG testing. If the hCG testing is positive and a viable pregnancy is confirmed by transvaginal ultrasound, placebo CHM will be continued till 8 weeks of gestation. If the hCG testing is negative or spontaneous miscarriage is confirmed, the drug treatment will be stopped.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control acupuncture and CHM</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Women will receive control acupuncture three times a week 4 weeks prior to ovarian stimulation for IVF and during ovarian stimulation, and before and after ET. They will also take CHM daily 4 weeks prior to IVF till the day of serum hCG testing. If the hCG testing is positive and a viable pregnancy is confirmed by transvaginal ultrasound, CHM will be continued till 8 weeks of gestation. If the hCG testing is negative or spontaneous miscarriage is confirmed, the drug treatment will be stopped.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control acupuncture and placebo CHM</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Women will receive control acupuncture three times a week 4 weeks prior to ovarian stimulation for IVF and during ovarian stimulation, and before and after ET. They will also take placebo CHM daily 4 weeks prior to IVF till the day of serum hCG testing. If the hCG testing is positive and a viable pregnancy is confirmed by transvaginal ultrasound, placebo CHM will be continued till 8 weeks of gestation. If the hCG testing is negative or spontaneous miscarriage is confirmed, the drug treatment will be stopped.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupuncture and Chinese Herbal Medicine</intervention_name>
    <description>1) acupuncture and CHM, 2) acupuncture and placebo CHM, 3) control acupuncture and CHM or 4) control acupuncture and placebo CHM by an interactive online computer program in a central office. Using a 1:1:1:1 treatment ratio, there will be 682 women assigned to each treatment group.</description>
    <arm_group_label>acupuncture and CHM</arm_group_label>
    <arm_group_label>acupuncture and placebo CHM</arm_group_label>
    <arm_group_label>control acupuncture and CHM</arm_group_label>
    <arm_group_label>control acupuncture and placebo CHM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women ≥20 to ≤40 years of age&#xD;
&#xD;
          2. Indications for IVF&#xD;
&#xD;
          3. Duration of infertility &gt;1 year&#xD;
&#xD;
          4. Undergoing IVF with an intention of fresh ET on day 3 or 5.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women with an intention to replace frozen embryos only.&#xD;
&#xD;
          2. Preimplantation genetic testing&#xD;
&#xD;
          3. History of recurrent miscarriages defined as having three consecutive miscarriages.&#xD;
&#xD;
          4. Having acupuncture or CHM for infertility within 3 months prior the IVF&#xD;
&#xD;
          5. Women with abnormal liver or renal function tests&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Undergoing IVF</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xiaoke Wu, Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>First Affiliated Hospital in Heilongjiang University of Chinese Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaoke Wu, Ph.D</last_name>
    <phone>13796025599</phone>
    <email>xiaokewu2002@vip.sina.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <state>Anhui</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Yunxia Cao</last_name>
      <phone>13605605972</phone>
    </contact>
    <investigator>
      <last_name>Yunxia Cao</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Lanzhou University</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Xuehong Zhang</last_name>
      <phone>13893215266</phone>
    </contact>
    <investigator>
      <last_name>Xuehong Zhang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Yingpu Sun</last_name>
      <phone>13503841888</phone>
    </contact>
    <investigator>
      <last_name>Yingpu Sun</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital, Tongji Medical College Huazhong University of Science &amp; Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Hanwang Zhang</last_name>
      <email>Hwzhang605@126.com</email>
    </contact>
    <investigator>
      <last_name>Hanwang Zhang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Huaian Maternal and Child Health Hospital</name>
      <address>
        <city>Huai'an</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Huiying Xue</last_name>
    </contact>
    <investigator>
      <last_name>Huiying Xue</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Nanjing University Medical School (Nanjing Drum Tower Hospital)</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Haixiang Sun</last_name>
      <phone>13851622008</phone>
    </contact>
    <investigator>
      <last_name>Haixiang Sun</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Xuzhou Central Hospital</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Yijuan Cao</last_name>
      <phone>18952171922</phone>
    </contact>
    <investigator>
      <last_name>Yijuan Cao</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Jiangxi Maternal and Child Health Hospital</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Qiongfang Wu</last_name>
    </contact>
    <investigator>
      <last_name>Qiongfang Wu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dalian Municipal Women and Children's Medical Center</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Xiaoguang Shao</last_name>
      <phone>13804086511</phone>
      <email>shaoxiaoguang03@sohu.com</email>
    </contact>
    <investigator>
      <last_name>Xiaoguang Shao</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shengjing Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Jichun Tan</last_name>
      <phone>18940251868</phone>
    </contact>
    <investigator>
      <last_name>Jichun Tan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Xibei Women and Children's Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Juanzi Shi</last_name>
    </contact>
    <investigator>
      <last_name>Juanzi Shi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Chinese University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Ronald Wang</last_name>
      <email>ccwang@cuhk.edu.hk</email>
    </contact>
    <investigator>
      <last_name>Ronald Wang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>September 22, 2021</last_update_submitted>
  <last_update_submitted_qc>September 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Heilongjiang University of Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Xiaoke Wu</investigator_full_name>
    <investigator_title>Professor and Director of Obstetrics and Gynecology Department</investigator_title>
  </responsible_party>
  <keyword>In Vitro Fertilization</keyword>
  <keyword>Chinese Herbal Medicine</keyword>
  <keyword>Acupuncture</keyword>
  <keyword>Live Birth</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Subject's privacy is protected undoubtedly at the time of the informed consent signing</ipd_description>
  </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/NCT04407871
org study id: IVFAct
nct id: NCT04407871
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The most successful treatment for infertility is in vitro fertilization (IVF), but less than
      10% of infertile couples undergo IVF because of the high cost and relatively low success
      rate. Many patients have tried complementary and alternative medical treatments as an
      adjuvant therapy to improve their IVF success. Acupuncture given 2-4 times around the day of
      embryo transfer has not been shown to improve the IVF live birth rate. Chinese Herbal
      Medicine (CHM) may improve the IVF pregnancy rates, but the evidence so far is inconclusive
      because of high risks of bias in these studies.

      The objective of this multi-centre double blind randomized trial is to evaluate the efficacy
      of acupuncture with or without CHM on the live birth of IVF. The randomization process will
      be coordinated through a central mechanism. A total of 2,728 subjects will be randomized in
      1:1:1:1 ratio in to one of the four treatment arms: 1) acupuncture and CHM, 2) acupuncture
      and placebo CHM, 3) control acupuncture and CHM or 4) control acupuncture and placebo CHM.
      Women will receive acupuncture or control acupuncture three times a week 4 weeks prior to IVF
      during ovarian stimulation, and before and after the embryo transfer. They will also take CHM
      or placebo CHM daily 4 weeks prior to IVF till a negative pregnancy test or till 8 weeks of
      gestation if pregnant.
The objective of this multi-centre double blind randomized trial is to evaluate the efficacy
      of acupuncture with or without CHM on the live birth of IVF. The randomization process will
      be coordinated through a central mechanism. A total of 2,728 subjects will be randomized in
      1:1:1:1 ratio in to one of the four treatment arms: 1) acupuncture and CHM, 2) acupuncture
      and placebo CHM, 3) control acupuncture and CHM or 4) control acupuncture and placebo CHM.
      Women will receive acupuncture or control acupuncture three times a week 4 weeks prior to IVF
      during ovarian stimulation, and before and after the embryo transfer. They will also take CHM
      or placebo CHM daily 4 weeks prior to IVF till a negative pregnancy test or till 8 weeks of
      gestation if pregnant.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Live birth
time frame: ≥20 weeks of gestation
description: Live birth defined as a delivery ≥20weeks gestation per transfer in the stimulated IVF cycles or in the first frozen-thawed embryo transfer cycle in those with elective freezing of all embryos
measure: Embryo quality: embryo scoring standard
time frame: On the third day after egg retrieval and before embryo transfer
description: Embryo quality is judged by embryo scoring standard
measure: Miscarriage rate
time frame: ≤42 weeks of gestation
description: Cumulative miscarriage rate
measure: Implantation rate
time frame: 2 weeks after embryo transfer
description: Cumulative implantation rate
measure: Positive serum human chorionic gonadotropin (hCG) level
time frame: 2 weeks after embryo transfer
description: Positive serum hCG level 2 weeks after embryo transfer
measure: Ongoing pregnancy rate
time frame: ≥8 weeks
description: Cumulative ongoing pregnancy rate
measure: Multiple pregnancy rate
time frame: ≥2 weeks after embryo transfer
description: Cumulative multiple pregnancy rate
measure: Ectopic pregnancy rate
time frame: ≥2 weeks after embryo transfer
description: Cumulative ectopic pregnancy rate
measure: Cumulative live birth rate
time frame: within 6 months after randomization
description: Cumulative live birth rate
measure: Changes in markers of stress, anxiety
time frame: ≤8 weeks of gestation
description: To elucidate the anxiety level as measured with serum cortisol concentration and Stait-Trait Anxiety Inventory (STAI)
measure: Health related quality of life(HRQoL)
time frame: ≤8 weeks of gestation
description: To determine women's health related quality of life (HRQoL) by short-form 36 (SF36)
measure: Patient acceptability: acupuncture trust score
time frame: On the day of embryo transfer
description: Patient acceptability of acupuncture to be measured by acupuncture trust score
measure: Side effects
time frame: ≤ 8 weeks of gestation
description: Side effects
measure: Congenital abnormalities
time frame: at 6 weeks postpartum
description: Judging by prenatal ultrasound and postnatal physical examination
measure: Pregnancy complications
time frame: ≤42 weeks of gestation
description: Complications of Pregnancy
arm group label: acupuncture and CHM
arm group type: Experimental
description: Women will receive acupuncture three times a week 4 weeks prior to ovarian stimulation for IVF and during ovarian stimulation, and before and after embryo transfer (ET). They will also take CHM daily 4 weeks prior to IVF till the day of serum hCG testing. If the hCG testing is positive and a viable pregnancy is confirmed by transvaginal ultrasound, CHM will be continued till 8 weeks of gestation. If the hCG testing is negative or spontaneous miscarriage is confirmed, the drug treatment will be stopped.
arm group label: acupuncture and placebo CHM
arm group type: Placebo Comparator
description: Women will receive acupuncture three times a week 4 weeks prior to ovarian stimulation for IVF and during ovarian stimulation, and before and after ET. They will also take placebo CHM daily 4 weeks prior to IVF till the day of serum hCG testing. If the hCG testing is positive and a viable pregnancy is confirmed by transvaginal ultrasound, placebo CHM will be continued till 8 weeks of gestation. If the hCG testing is negative or spontaneous miscarriage is confirmed, the drug treatment will be stopped.
arm group label: control acupuncture and CHM
arm group type: Placebo Comparator
description: Women will receive control acupuncture three times a week 4 weeks prior to ovarian stimulation for IVF and during ovarian stimulation, and before and after ET. They will also take CHM daily 4 weeks prior to IVF till the day of serum hCG testing. If the hCG testing is positive and a viable pregnancy is confirmed by transvaginal ultrasound, CHM will be continued till 8 weeks of gestation. If the hCG testing is negative or spontaneous miscarriage is confirmed, the drug treatment will be stopped.
arm group label: control acupuncture and placebo CHM
arm group type: Placebo Comparator
description: Women will receive control acupuncture three times a week 4 weeks prior to ovarian stimulation for IVF and during ovarian stimulation, and before and after ET. They will also take placebo CHM daily 4 weeks prior to IVF till the day of serum hCG testing. If the hCG testing is positive and a viable pregnancy is confirmed by transvaginal ultrasound, placebo CHM will be continued till 8 weeks of gestation. If the hCG testing is negative or spontaneous miscarriage is confirmed, the drug treatment will be stopped.
intervention type: Other
intervention name: Acupuncture and Chinese Herbal Medicine
description: 1) acupuncture and CHM, 2) acupuncture and placebo CHM, 3) control acupuncture and CHM or 4) control acupuncture and placebo CHM by an interactive online computer program in a central office. Using a 1:1:1:1 treatment ratio, there will be 682 women assigned to each treatment group.
arm group label: acupuncture and CHM
arm group label: acupuncture and placebo CHM
arm group label: control acupuncture and CHM
arm group label: control acupuncture and placebo CHM
criteria: 
gender: Female
gender based: Yes
gender description: Undergoing IVF
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: Xiaoke Wu, Ph.D
role: Study Chair
affiliation: First Affiliated Hospital in Heilongjiang University of Chinese Medicine
last name: Xiaoke Wu, Ph.D
phone: 13796025599
email: xiaokewu2002@vip.sina.com
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country: China
responsible party type: Principal Investigator
investigator affiliation: Heilongjiang University of Chinese Medicine
investigator full name: Xiaoke Wu
investigator title: Professor and Director of Obstetrics and Gynecology Department
sharing ipd: No
ipd description: Subject's privacy is protected undoubtedly at the time of the informed consent signing