<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/NCT03810157</url>
  </required_header>
  <id_info>
    <org_study_id>1215</org_study_id>
    <nct_id>NCT03810157</nct_id>
  </id_info>
  <brief_title>Does LAH May Improve the Pregnancy Outcomes?</brief_title>
  <official_title>Does Laser-assisted Hatching(LAH) May Improve the Pregnancy Outcomes in Human?</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>
      A defect in the hatching stage is considered an important cause of implantation failure.&#xD;
      Therefore, assisted hatching (AH), which involves artificial disruption of the zona&#xD;
      pellucida, has been proposed as a method for improving the capacity of the embryo to implant.&#xD;
      But the advantage of using laser to facilitate the hatching process of embryos in ART&#xD;
      practice is debatable, and an optimum strategy for performing LAH remains elusive. Therefore,&#xD;
      the aim of this study was to evaluate the effects of laser-assisted hatching(LAH) on clinical&#xD;
      outcomes. Patients were randomly divided into control and LAH groups. The zona pellucida was&#xD;
      thinned or drilled with a diode laser. Relevant parameters are recorded to evaluate the&#xD;
      validity of LAH in ART.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hatching is a very important process for successful implantation involving the breaking of&#xD;
      the embryo out of the zona pellucida at the blastocyst stage. Inadequate hatching of the&#xD;
      blastocyst might lead to implantation failure in ART. Currently, a variety of AH techniques&#xD;
      have been used including zona thinning and the opening or complete removal of the zona by&#xD;
      laser. But the advantage of using laser to facilitate the hatching process of embryos in ART&#xD;
      practice is debatable, and an optimum strategy for performing LAH remains elusive. Therefore,&#xD;
      the investigator aim to discuss the effectiveness of LAH in ART.&#xD;
&#xD;
      In this study, patients were randomly divided into control and LAH groups. A quarter of zona&#xD;
      pellucida of the cleavage-stage embryo was thinned to 6.6 μm. All operation was performed in&#xD;
      the empty region without contact to the blastomere in order to minimize the blastomere&#xD;
      damage. The ZP of blastocyst was drilled with laser, the ZP opening 20% of its initial&#xD;
      length. The operation was performed in the opposite region of ICM in order to minimize the&#xD;
      damage. In the control group, embryos were transplanted without LAH. The rate of clinical&#xD;
      pregnancy, live-birth, miscarriage, multiple gestation were evaluated. This research intends&#xD;
      to discuss whether LAH can improve the clinical outcomes in ART, and further choice the&#xD;
      appropriate LAH action site.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 26, 2018</start_date>
  <completion_date type="Anticipated">November 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 1, 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>Efficacy of LAH in ART</measure>
    <time_frame>6 months</time_frame>
    <description>Assess the clinical pregnancy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of LAH in ART</measure>
    <time_frame>1 year</time_frame>
    <description>Incidence of LAH adverse events was assessed by miscarriage rate and multiple gestation rate.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Pregnancy Outcomes</condition>
  <arm_group>
    <arm_group_label>Laser-assisted hatching system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Embryos were exposed to a dose of laser energy focused outside the zona pellucida by aser-assisted hatching system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Nothing is done.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laser-assisted hatching system</intervention_name>
    <description>The ZP was thinned or drilled with the Laser-assisted hatching system. The laser pulse was 0.296 ms. Laser aperture was 8μm.</description>
    <arm_group_label>Laser-assisted hatching system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing IVF/ICSI-ET cycle；&#xD;
&#xD;
          -  The zone pellucida of the cleavage-stage embryo is thicker than 8 μm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Number of embryos transferred per cycle &gt;2;&#xD;
&#xD;
          -  The transferred embryos including fresh and frozen cycle in the same cycle;&#xD;
&#xD;
          -  Embryos developed from the frozen-thawed oocytes.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bo Li</last_name>
    <role>Study Chair</role>
    <affiliation>Tang-Du Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ming Wang</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>Ming Wang</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 14, 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>June 24, 2019</last_update_submitted>
  <last_update_submitted_qc>June 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>laser-assisted hatching (LAH)</keyword>
  <keyword>zona pellucida</keyword>
  <keyword>cryopreservation</keyword>
  <keyword>pregnancy outcomes</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/NCT03810157
org study id: 1215
nct id: NCT03810157
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A defect in the hatching stage is considered an important cause of implantation failure.
      Therefore, assisted hatching (AH), which involves artificial disruption of the zona
      pellucida, has been proposed as a method for improving the capacity of the embryo to implant.
      But the advantage of using laser to facilitate the hatching process of embryos in ART
      practice is debatable, and an optimum strategy for performing LAH remains elusive. Therefore,
      the aim of this study was to evaluate the effects of laser-assisted hatching(LAH) on clinical
      outcomes. Patients were randomly divided into control and LAH groups. The zona pellucida was
      thinned or drilled with a diode laser. Relevant parameters are recorded to evaluate the
      validity of LAH in ART.
Hatching is a very important process for successful implantation involving the breaking of
      the embryo out of the zona pellucida at the blastocyst stage. Inadequate hatching of the
      blastocyst might lead to implantation failure in ART. Currently, a variety of AH techniques
      have been used including zona thinning and the opening or complete removal of the zona by
      laser. But the advantage of using laser to facilitate the hatching process of embryos in ART
      practice is debatable, and an optimum strategy for performing LAH remains elusive. Therefore,
      the investigator aim to discuss the effectiveness of LAH in ART.

      In this study, patients were randomly divided into control and LAH groups. A quarter of zona
      pellucida of the cleavage-stage embryo was thinned to 6.6 μm. All operation was performed in
      the empty region without contact to the blastomere in order to minimize the blastomere
      damage. The ZP of blastocyst was drilled with laser, the ZP opening 20% of its initial
      length. The operation was performed in the opposite region of ICM in order to minimize the
      damage. In the control group, embryos were transplanted without LAH. The rate of clinical
      pregnancy, live-birth, miscarriage, multiple gestation were evaluated. This research intends
      to discuss whether LAH can improve the clinical outcomes in ART, and further choice the
      appropriate LAH action site.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Efficacy of LAH in ART
time frame: 6 months
description: Assess the clinical pregnancy
measure: Feasibility of LAH in ART
time frame: 1 year
description: Incidence of LAH adverse events was assessed by miscarriage rate and multiple gestation rate.
arm group label: Laser-assisted hatching system
arm group type: Experimental
description: Embryos were exposed to a dose of laser energy focused outside the zona pellucida by aser-assisted hatching system.
arm group label: Control group
arm group type: No Intervention
description: Nothing is done.
intervention type: Device
intervention name: Laser-assisted hatching system
description: The ZP was thinned or drilled with the Laser-assisted hatching system. The laser pulse was 0.296 ms. Laser aperture was 8μm.
arm group label: Laser-assisted hatching system
criteria: 
gender: Female
minimum age: 22 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bo Li
role: Study Chair
affiliation: Tang-Du Hospital
last name: Ming Wang
phone: 8613259809290
email: wangmingbio@snnu.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor