<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/NCT03810040</url>
  </required_header>
  <id_info>
    <org_study_id>123456</org_study_id>
    <nct_id>NCT03810040</nct_id>
  </id_info>
  <brief_title>Effect of Degranulation Needle With Different Diameters on the Rate Good Embryo in IVF</brief_title>
  <official_title>Effect of Degranulation Needle on the Rate Good Embryo in IVF</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>
      Good-quality embryos are critical for the success of in vitro fertilization (IVF). But, to&#xD;
      date, there is no report of the effect of different diameters denuding pipette on the embryos&#xD;
      quality. To investigate the effect of denuding pipette in IVF outcomes, we plan to recruit&#xD;
      women undergoing IVF treatment cycles and classified them into two groups according to the&#xD;
      different diameters. Consequently, the rate of fertilization, zygotes cleaved, top quality&#xD;
      embryos on D3, and blastocysts obtained were recorded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Good-quality embryos are critical for the success of in vitro fertilization (IVF). But, to&#xD;
      date, there is no report of the effect of different diameters denuding pipette on the embryos&#xD;
      quality. To investigate the effect of denuding pipette in IVF outcomes, we plan to recruit&#xD;
      women undergoing IVF treatment cycles and classified them into two groups according to the&#xD;
      different diameters. The participants were divided into two group. Odd-numbered days the&#xD;
      zygotes were degranulated with the 140 microns needles. Even-numbered days the zygotes were&#xD;
      degranulated with the 150 microns needles. Consequently, the rate of fertilization, zygotes&#xD;
      cleaved, top quality embryos on D3, and blastocysts obtained were recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">November 2019</completion_date>
  <primary_completion_date type="Anticipated">May 2019</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>quality of embryo</measure>
    <time_frame>one year</time_frame>
    <description>embryo quality assessed by good embryo rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical outcome - clinical prengancy rate</measure>
    <time_frame>three years</time_frame>
    <description>clinical prengancy rate</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Embryo</condition>
  <arm_group>
    <arm_group_label>Odd-numbered days</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Once odd-numbered days the zytoges of IVF cycle were collected. The 140 microns denuding pipette was used.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Even-numbered days</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once even-numbered days the zytoges of IVF cycle were collected. The 150 microns denuding pipette was used.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>140 microns denuding pipette</intervention_name>
    <description>the degranulated needle size was 140 microns</description>
    <arm_group_label>Odd-numbered days</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>150 microns denuding pipette</intervention_name>
    <description>the degranulated needle size was 150 microns</description>
    <arm_group_label>Even-numbered days</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first cyele of IVF treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  oocyte number less than 4&#xD;
&#xD;
          -  oocyte number over than 25&#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>jin ni</last_name>
    <role>Study Director</role>
    <affiliation>Tang-Du 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>
    <contact>
      <last_name>wang ming</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 5, 2018</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>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Embryos quality</keyword>
  <keyword>In vitro fertilization</keyword>
  <keyword>Denuding pipette</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03810040
org study id: 123456
nct id: NCT03810040
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Good-quality embryos are critical for the success of in vitro fertilization (IVF). But, to
      date, there is no report of the effect of different diameters denuding pipette on the embryos
      quality. To investigate the effect of denuding pipette in IVF outcomes, we plan to recruit
      women undergoing IVF treatment cycles and classified them into two groups according to the
      different diameters. Consequently, the rate of fertilization, zygotes cleaved, top quality
      embryos on D3, and blastocysts obtained were recorded.
Good-quality embryos are critical for the success of in vitro fertilization (IVF). But, to
      date, there is no report of the effect of different diameters denuding pipette on the embryos
      quality. To investigate the effect of denuding pipette in IVF outcomes, we plan to recruit
      women undergoing IVF treatment cycles and classified them into two groups according to the
      different diameters. The participants were divided into two group. Odd-numbered days the
      zygotes were degranulated with the 140 microns needles. Even-numbered days the zygotes were
      degranulated with the 150 microns needles. Consequently, the rate of fertilization, zygotes
      cleaved, top quality embryos on D3, and blastocysts obtained were recorded.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: quality of embryo
time frame: one year
description: embryo quality assessed by good embryo rate
measure: clinical outcome - clinical prengancy rate
time frame: three years
description: clinical prengancy rate
arm group label: Odd-numbered days
arm group type: Active Comparator
description: Once odd-numbered days the zytoges of IVF cycle were collected. The 140 microns denuding pipette was used.
arm group label: Even-numbered days
arm group type: Experimental
description: Once even-numbered days the zytoges of IVF cycle were collected. The 150 microns denuding pipette was used.
intervention type: Device
intervention name: 140 microns denuding pipette
description: the degranulated needle size was 140 microns
arm group label: Odd-numbered days
intervention type: Device
intervention name: 150 microns denuding pipette
description: the degranulated needle size was 150 microns
arm group label: Even-numbered days
criteria: 
gender: Female
minimum age: 22 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: jin ni
role: Study Director
affiliation: Tang-Du Hospital
last name: wang ming
phone: 8613259809290
email: wangmingbio@snnu.edu.cn
facility: 
contact: 
country: China
responsible party type: Sponsor
sharing ipd: No