<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/NCT03810001</url>
  </required_header>
  <id_info>
    <org_study_id>201801</org_study_id>
    <nct_id>NCT03810001</nct_id>
  </id_info>
  <brief_title>Mechanical Stimulation Improve the Fertilization in ICSI Cycle</brief_title>
  <official_title>Use of Mechanical Stimulation to Active Oocytes Can Improve the Fertilization in Intracytoplasmic Sperm Injection Cycle</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tang-Du Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tang-Du Hospital</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>
      Most fertilization failures after ICSI are caused by failure of oocyte activation defects.&#xD;
      But, to date, there is no effective method to overcome this obstacle. To investigate the&#xD;
      effect of mechanical stimulation on fertilization failures, investigators plan to recruit&#xD;
      women undergoing ICSI treatment cycles. The retrieved sibling oocytes from the patients were&#xD;
      randomly divided into two groups. The control group conducted the standard ICSI procedure,&#xD;
      while the experimental group conducted the modified ICSI procedure.Consequently, the&#xD;
      fertilization rate, 2PN (two pronuclei) rate, 1PN rate, oocyte degradation rate,and&#xD;
      exploitable embryos on D3 were recorded to evaluate ICSI cycle outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Normal fertilization is the critical for the success of ICSI. To investigate the effect of&#xD;
      mechanical stimulation on fertilization, investigators plan to recruit women undergoing ICSI&#xD;
      treatment cycles. Exclusion criteria: Patients older than 40 years, the maturation oocytes&#xD;
      less than 6. The retrieved sibling oocytes from the patient were randomly divided into two&#xD;
      groups. The control group conducted the standard ICSI procedure, while the experimental group&#xD;
      conducted the modified ICSI procedure. The modified ICSI procedure involved a&#xD;
      micromanipulation mechanical stimulation between insertion of the microinjection needle into&#xD;
      the oocyte and expulsion of the spermatozoon from the needle to the ooplasm, without&#xD;
      additional reagents treatment. Consequently, the fertilization rate, 2PN rate, 1PN rate,&#xD;
      oocyte degradation rate, and exploitable embryos on D3 were recorded. The investigators aim&#xD;
      to evaluate whether the mechanical stimulation can be used to improve the normal&#xD;
      fertilization and embryo quality in ICSI cycles.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 11, 2018</start_date>
  <completion_date type="Anticipated">December 25, 2019</completion_date>
  <primary_completion_date type="Anticipated">November 20, 2019</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Normal fertilization rate</measure>
    <time_frame>6 months</time_frame>
    <description>2PN (two pronuclei and two polar bodies) rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility and Efficacy of Mechanical Stimulation</measure>
    <time_frame>6 months</time_frame>
    <description>Incidence of mechanical stimulation adverse events assessed by abnormally fertilization rate and oocytes degradation rate. Efficacy assessed by the exploitable embryo rate.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Fertilization</condition>
  <arm_group>
    <arm_group_label>standard ICSI procedure</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>a single spermatozoon was injected into the ooplasm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>modified ICSI procedure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>slight mechanical stimulation before standard ICSI procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mechanical Stimulation</intervention_name>
    <description>micromanipulation technique before insertion of the microinjection needle into the oocyte and expulsion of the spermatozoon</description>
    <arm_group_label>modified ICSI procedure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  oocytes number ≥ 8;&#xD;
&#xD;
          -  women undergoing intracytoplasmic sperm injection cycle.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  maturation oocytes number less than 6.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>li bo</last_name>
    <role>Study Chair</role>
    <affiliation>Reproductive Medicine Center, Tangdu Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>wang ming</last_name>
    <phone>8613259809290</phone>
    <email>wangmingbio@snnu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Tangdu Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710038</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>wang ming</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>September 24, 2019</last_update_submitted>
  <last_update_submitted_qc>September 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>oocyte activation</keyword>
  <keyword>intracytoplasmic sperm injection(ICSI)</keyword>
  <keyword>mechanical stimulation</keyword>
  <keyword>2PN rate</keyword>
  <!-- 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/NCT03810001
org study id: 201801
nct id: NCT03810001
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Most fertilization failures after ICSI are caused by failure of oocyte activation defects.
      But, to date, there is no effective method to overcome this obstacle. To investigate the
      effect of mechanical stimulation on fertilization failures, investigators plan to recruit
      women undergoing ICSI treatment cycles. The retrieved sibling oocytes from the patients were
      randomly divided into two groups. The control group conducted the standard ICSI procedure,
      while the experimental group conducted the modified ICSI procedure.Consequently, the
      fertilization rate, 2PN (two pronuclei) rate, 1PN rate, oocyte degradation rate,and
      exploitable embryos on D3 were recorded to evaluate ICSI cycle outcomes.
Normal fertilization is the critical for the success of ICSI. To investigate the effect of
      mechanical stimulation on fertilization, investigators plan to recruit women undergoing ICSI
      treatment cycles. Exclusion criteria: Patients older than 40 years, the maturation oocytes
      less than 6. The retrieved sibling oocytes from the patient were randomly divided into two
      groups. The control group conducted the standard ICSI procedure, while the experimental group
      conducted the modified ICSI procedure. The modified ICSI procedure involved a
      micromanipulation mechanical stimulation between insertion of the microinjection needle into
      the oocyte and expulsion of the spermatozoon from the needle to the ooplasm, without
      additional reagents treatment. Consequently, the fertilization rate, 2PN rate, 1PN rate,
      oocyte degradation rate, and exploitable embryos on D3 were recorded. The investigators aim
      to evaluate whether the mechanical stimulation can be used to improve the normal
      fertilization and embryo quality in ICSI cycles.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Normal fertilization rate
time frame: 6 months
description: 2PN (two pronuclei and two polar bodies) rate
measure: Feasibility and Efficacy of Mechanical Stimulation
time frame: 6 months
description: Incidence of mechanical stimulation adverse events assessed by abnormally fertilization rate and oocytes degradation rate. Efficacy assessed by the exploitable embryo rate.
arm group label: standard ICSI procedure
arm group type: No Intervention
description: a single spermatozoon was injected into the ooplasm
arm group label: modified ICSI procedure
arm group type: Experimental
description: slight mechanical stimulation before standard ICSI procedure
intervention type: Behavioral
intervention name: Mechanical Stimulation
description: micromanipulation technique before insertion of the microinjection needle into the oocyte and expulsion of the spermatozoon
arm group label: modified ICSI procedure
criteria: 
gender: Female
minimum age: 22 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: li bo
role: Study Chair
affiliation: Reproductive Medicine Center, Tangdu Hospital
last name: wang ming
phone: 8613259809290
email: wangmingbio@snnu.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor