<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/NCT01695096</url>
  </required_header>
  <id_info>
    <org_study_id>ibnsinaH</org_study_id>
    <secondary_id>ibnsinaH</secondary_id>
    <nct_id>NCT01695096</nct_id>
  </id_info>
  <brief_title>High Versus Free Humidity Incubators; A Randomized Clinical Trial</brief_title>
  <official_title>High Versus Free Humidity Incubators; A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ibn Sina Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ganna Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ibn Sina Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare Top quality embryos either day3 or day 5, Pregnancy rate and most importantly&#xD;
      ongoing pregnancy rate between high humidity incubators and humidity free incubators&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When the IVF started the majority of incubators designed to support high humidity because the&#xD;
      designers and IVF specialists believed that the humidity will maintain stable ph and Temp.&#xD;
&#xD;
      Recent reports suggest that humidity is recommended and the others suggest no difference So&#xD;
      we decide to go for this RCT. Nevertheless; high humidity is maintained in vivo (uterus and&#xD;
      fallopian tubes) due to the fluid content and stable body temperatures at 37°C. David&#xD;
      McCulloch reported 15% reduction of the miscarriage rate after changing the humidity from 76%&#xD;
      to 100% (Textbook of Assisted Reproductive Techniques: Laboratory Perspectives, Fourth&#xD;
      Edition). Some embryologists claim that the humidity free incubators may increase the chance&#xD;
      of chemical pregnancy and early fetal loss (Private center IbnSina IVF, Sohag, Egypt.&#xD;
      unpublished data). This observations are never tested in a well designed randomized clinical&#xD;
      trial (RCT) to eliminate the probability of chance and to reach a solid evidence.&#xD;
&#xD;
      The question that should be asked : is high humidity culture should be applied or there is no&#xD;
      difference between dry and high humidity culture conditions?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ongoing pregnancy rate</measure>
    <time_frame>18 months</time_frame>
    <description>assessing the ongoing pregnancy rate and its difference between the 2 study arms.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">284</enrollment>
  <condition>Ongoing Pregnancy Rate</condition>
  <arm_group>
    <arm_group_label>The Embryos will be cultured on a humidity free incubator</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We will set the humidity level to 0.0% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The Embryos will be cultured on a &gt;95% humidity incubator</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>We will set the humidity level to &gt; 95% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The Embryos will be cultured on a humidity free incubator</intervention_name>
    <description>We will set the humidity level to 0.0% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results.</description>
    <arm_group_label>The Embryos will be cultured on a humidity free incubator</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The Embryos will be cultured on a &gt;95% humidity incubator</intervention_name>
    <description>We will set the humidity level to 95% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results.</description>
    <arm_group_label>The Embryos will be cultured on a &gt;95% humidity incubator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &lt; 33 years, BMI&lt;30,&#xD;
&#xD;
          -  Normo Responder(&gt;8 MII)&#xD;
&#xD;
          -  Fresh Cycle&#xD;
&#xD;
          -  Ist attempt&#xD;
&#xD;
          -  Normal or mild oligoasthenoteratozoospermia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Testicular sperm&#xD;
&#xD;
          -  &lt; 8 MII collected&#xD;
&#xD;
          -  difficult transfer cycle&#xD;
&#xD;
          -  Endometriotic patients&#xD;
&#xD;
          -  Poor Endometrium &lt; 8mm diameter at Ovum Pickup&#xD;
&#xD;
          -  any other medical diseases&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>33 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Muhammad F. Abdel-Raheem, Lab Director</last_name>
    <role>Principal Investigator</role>
    <affiliation>IBNSINA IVF Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Muhammad El Hady, Lab Director</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ganna Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed Y. Abdel-Rahman, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>IBNSINA IVF center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gannah IVF unit, Gannah Hospital</name>
      <address>
        <city>Giza</city>
        <zip>12345</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IbnSina IVF unit, IbnSina Hospital, El Areef Square</name>
      <address>
        <city>Sohag</city>
        <zip>12345</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <link>
    <url>http://www.facebook.com/groups/314911565200565/</url>
    <description>Facebook group for Gannah hospital, site doing the study</description>
  </link>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>June 28, 2016</last_update_submitted>
  <last_update_submitted_qc>June 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ibn Sina Hospital</investigator_affiliation>
    <investigator_full_name>Muhammad Fawzy</investigator_full_name>
    <investigator_title>IVF Laboratory Director</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/NCT01695096
org study id: ibnsinaH
secondary id: ibnsinaH
nct id: NCT01695096
lead sponsor: 
collaborator: 
has dmc: Yes
To compare Top quality embryos either day3 or day 5, Pregnancy rate and most importantly
      ongoing pregnancy rate between high humidity incubators and humidity free incubators
When the IVF started the majority of incubators designed to support high humidity because the
      designers and IVF specialists believed that the humidity will maintain stable ph and Temp.

      Recent reports suggest that humidity is recommended and the others suggest no difference So
      we decide to go for this RCT. Nevertheless; high humidity is maintained in vivo (uterus and
      fallopian tubes) due to the fluid content and stable body temperatures at 37°C. David
      McCulloch reported 15% reduction of the miscarriage rate after changing the humidity from 76%
      to 100% (Textbook of Assisted Reproductive Techniques: Laboratory Perspectives, Fourth
      Edition). Some embryologists claim that the humidity free incubators may increase the chance
      of chemical pregnancy and early fetal loss (Private center IbnSina IVF, Sohag, Egypt.
      unpublished data). This observations are never tested in a well designed randomized clinical
      trial (RCT) to eliminate the probability of chance and to reach a solid evidence.

      The question that should be asked : is high humidity culture should be applied or there is no
      difference between dry and high humidity culture conditions?
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
measure: Ongoing pregnancy rate
time frame: 18 months
description: assessing the ongoing pregnancy rate and its difference between the 2 study arms.
arm group label: The Embryos will be cultured on a humidity free incubator
arm group type: Experimental
description: We will set the humidity level to 0.0% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results.
arm group label: The Embryos will be cultured on a >95% humidity incubator
arm group type: Placebo Comparator
description: We will set the humidity level to > 95% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results.
intervention type: Other
intervention name: The Embryos will be cultured on a humidity free incubator
description: We will set the humidity level to 0.0% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results.
arm group label: The Embryos will be cultured on a humidity free incubator
intervention type: Other
intervention name: The Embryos will be cultured on a >95% humidity incubator
description: We will set the humidity level to 95% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results.
arm group label: The Embryos will be cultured on a >95% humidity incubator
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 33 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Muhammad F. Abdel-Raheem, Lab Director
role: Principal Investigator
affiliation: IBNSINA IVF Center
last name: Muhammad El Hady, Lab Director
role: Principal Investigator
affiliation: Ganna Hospital
last name: Mohamed Y. Abdel-Rahman, M.D.
role: Study Director
affiliation: IBNSINA IVF center
facility: 
facility: 
country: Egypt
url: http://www.facebook.com/groups/314911565200565/
description: Facebook group for Gannah hospital, site doing the study
responsible party type: Principal Investigator
investigator affiliation: Ibn Sina Hospital
investigator full name: Muhammad Fawzy
investigator title: IVF Laboratory Director