<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/NCT03833869</url>
  </required_header>
  <id_info>
    <org_study_id>0020-19-WOMC</org_study_id>
    <nct_id>NCT03833869</nct_id>
  </id_info>
  <brief_title>Assisted Hatching in Frozen Blastocysts</brief_title>
  <official_title>The Effect of Assisted Hatching on Implantation Rate in Frozen Blastocyst Transfer - a Prospective Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wolfson Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wolfson Medical Center</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>
      The current study aims to assess the effect of assisted hatching on the implantation rate of&#xD;
      frozen blastocytes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Zona Pellucida protects the ovum from the penetration of multiple sperm, and from&#xD;
      mechanical and physiological damage until the fertilized ovum reaches the uterus.&#xD;
      Subsequently, spontaneous hatching occurs, and enables the embryo to attach to the&#xD;
      endometrium. The technique of assisted hatching was originally investigated as a means to&#xD;
      improve implantation in cases of zona hardening, and is commonly performed in 3-day embryos.&#xD;
      In the current study, the investigators aim to investigate the effect of assisted hatching on&#xD;
      5-day frozen embryos.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">March 2020</completion_date>
  <primary_completion_date type="Anticipated">March 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Implantation rate</measure>
    <time_frame>Five to six weeks following embryo transfer</time_frame>
    <description>Number of gestational sacs demonstrated on ultrasound divided by the number of embryos transferred (expressed as percentage)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Chemical pregnancy</measure>
    <time_frame>Five to six weeks following embryo transfer</time_frame>
    <description>Increase and subsequent decrease in beta HCG levels with no evidence of gestational sac on ultrasound</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early spontaneous abortion</measure>
    <time_frame>Up to 15 weeks from embryo transfer</time_frame>
    <description>Spontaneous abortion of pregnancy during the first trimester of pregnancy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>ART</condition>
  <arm_group>
    <arm_group_label>Assisted hatching</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Five-day frozen embryos will undergo assisted hatching prior to embryo transfer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Five-day frozen embryos will not undergo any additional procedures prior to embryo transfer</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Assisted hatching</intervention_name>
    <description>Controlled hatching of the zona pellucida in the laboratory prior to embryo transfer</description>
    <arm_group_label>Assisted hatching</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In-vitro fertilization patients at the investigators' institution, intended to undergo&#xD;
             a transfer of a frozen five-day embryo (blastocyte)&#xD;
&#xD;
          -  18 to 39 years old&#xD;
&#xD;
          -  First to third treatment cycle&#xD;
&#xD;
          -  Patient has previously had a maximum of four embryos transferred.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Over 40 years old&#xD;
&#xD;
          -  Congenital or acquired uterine malformations&#xD;
&#xD;
          -  Hydrosalpinx&#xD;
&#xD;
          -  Chronic autoimmune diseases&#xD;
&#xD;
          -  Embryo intended to be undergo preimplantation genetic diagnosis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hadas Ganer Herman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Edith Wolfson Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hadas Ganer Herman, MD</last_name>
    <phone>9720526206696</phone>
    <email>hadassganer@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Edith Wolfson Medical Center</name>
      <address>
        <city>H̱olon</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hadas Ganer Herman, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>June 6, 2019</last_update_submitted>
  <last_update_submitted_qc>June 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wolfson Medical Center</investigator_affiliation>
    <investigator_full_name>Hadas Ganer Herman</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03833869
org study id: 0020-19-WOMC
nct id: NCT03833869
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The current study aims to assess the effect of assisted hatching on the implantation rate of
      frozen blastocytes.
The Zona Pellucida protects the ovum from the penetration of multiple sperm, and from
      mechanical and physiological damage until the fertilized ovum reaches the uterus.
      Subsequently, spontaneous hatching occurs, and enables the embryo to attach to the
      endometrium. The technique of assisted hatching was originally investigated as a means to
      improve implantation in cases of zona hardening, and is commonly performed in 3-day embryos.
      In the current study, the investigators aim to investigate the effect of assisted hatching on
      5-day frozen embryos.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Implantation rate
time frame: Five to six weeks following embryo transfer
description: Number of gestational sacs demonstrated on ultrasound divided by the number of embryos transferred (expressed as percentage)
measure: Chemical pregnancy
time frame: Five to six weeks following embryo transfer
description: Increase and subsequent decrease in beta HCG levels with no evidence of gestational sac on ultrasound
measure: Early spontaneous abortion
time frame: Up to 15 weeks from embryo transfer
description: Spontaneous abortion of pregnancy during the first trimester of pregnancy
arm group label: Assisted hatching
arm group type: Experimental
description: Five-day frozen embryos will undergo assisted hatching prior to embryo transfer
arm group label: Control
arm group type: No Intervention
description: Five-day frozen embryos will not undergo any additional procedures prior to embryo transfer
intervention type: Procedure
intervention name: Assisted hatching
description: Controlled hatching of the zona pellucida in the laboratory prior to embryo transfer
arm group label: Assisted hatching
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 39 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hadas Ganer Herman, MD
role: Principal Investigator
affiliation: Edith Wolfson Medical Center
last name: Hadas Ganer Herman, MD
phone: 9720526206696
email: hadassganer@yahoo.com
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Wolfson Medical Center
investigator full name: Hadas Ganer Herman
investigator title: Principal Investigator