<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/NCT03823235</url>
  </required_header>
  <id_info>
    <org_study_id>IbnSina-Humidity</org_study_id>
    <nct_id>NCT03823235</nct_id>
  </id_info>
  <brief_title>Humidified Culture and Live Birth After ICSI</brief_title>
  <official_title>Humidified Incubator Effect on Live Birth Rate After ICSI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ibn Sina Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Banoon IVF Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Quena IVF Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Amshag IVF Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ibn Sina Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Humidity for human embryo culture has been raised as essential with advantageous effect on&#xD;
      clinical pregnancy and ongoing pregnancy after ICSI compared with a dry incubator. Whether&#xD;
      the deleterious effect of dry culture would have an extended effect reaches the live birth&#xD;
      rate needs to be examined. This RCT is to examine the effect of dry and humidified culture on&#xD;
      live birth rates after ICSI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">March 27, 2020</completion_date>
  <primary_completion_date type="Actual">March 27, 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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Live birth rate</measure>
    <time_frame>30 weeks</time_frame>
    <description>Viable neonate after 30 weeks of gestation per initiated cycle</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cumulative live birth rate</measure>
    <time_frame>One year</time_frame>
    <description>Viable neonate after 30 weeks of gestation after one fresh and/or one frozen-warmed transfer per initiated cycle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ongoing pregnancy rate</measure>
    <time_frame>12 weeks of gestation</time_frame>
    <description>Continued pregnancy after 12 weeks of gestation per initiated cycle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative ongoing pregnancy rate</measure>
    <time_frame>12 weeks of gestation</time_frame>
    <description>Continued pregnancy after 12 weeks of gestation per initiated cycle within one year of randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>7 weeks of gestation</time_frame>
    <description>Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative clinical pregnancy rate</measure>
    <time_frame>7 weeks of gestation</time_frame>
    <description>Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle within one year of randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implantation rate</measure>
    <time_frame>7 weeks of gestation</time_frame>
    <description>Number of sacs with a heartbeat per number of embryo transferred</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative implantation rate</measure>
    <time_frame>7 weeks of gestation</time_frame>
    <description>Number of sacs with a heartbeat per number of embryo transferred within one year of randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ongoing implantation rate</measure>
    <time_frame>12 weeks of gestation</time_frame>
    <description>Number of sacs with a heartbeat per number of embryo transferred</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative ongoing implantation rate</measure>
    <time_frame>12 weeks of gestation</time_frame>
    <description>Number of sacs with a heartbeat per number of embryo transferred within one year of randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preterm birth rate</measure>
    <time_frame>37 weeks</time_frame>
    <description>number of babies born before 37 weeks of gestation per total birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Very preterm birth</measure>
    <time_frame>32 weeks</time_frame>
    <description>number of babies born before 32 weeks of gestation per total birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low birth weight rate</measure>
    <time_frame>40 weeks of gestation</time_frame>
    <description>number of babies with &lt; 2500 gm per total birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fertilization rate</measure>
    <time_frame>6 days of culture</time_frame>
    <description>fertilized oocytes with two pronuclei per Metaphase II injected</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cleavage rate</measure>
    <time_frame>6 days of culture</time_frame>
    <description>Cleaved embryo per fertilized oocyte</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of high-quality day-3 embryos</measure>
    <time_frame>6 days of culture</time_frame>
    <description>Embryos with seven or eight blastomeres of appropriate-size, and &lt; 10% fragmentation by volume per fertilized oocyte</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blastocyst formation rate</measure>
    <time_frame>6 days of culture</time_frame>
    <description>Formed blastocyst on day 5/6 from fertilized oocytes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of high-quality blastocyst</measure>
    <time_frame>6 days of culture</time_frame>
    <description>Blastocysts ≥ 3.1.1 grade per fertilized oocyte</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of utilizable blastocyst</measure>
    <time_frame>6 days of culture</time_frame>
    <description>Transferred and cryopreserved blastocysts from fertilized oocytes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1837</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Culture of human embryo in non-humidified incubator</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Embryo culture after in vitro fertilization in incubator with no humidity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Culture of human embryo in humidified incubator</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Embryo culture after in vitro fertilization in incubator with humidity</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Human embryo culture</intervention_name>
    <description>humidifed or dry incubator</description>
    <arm_group_label>Culture of human embryo in non-humidified incubator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women undergoing a first or second ICSI attempts&#xD;
&#xD;
          -  Primary or secondary infertility with a BMI of &lt; 31 kg/m2&#xD;
&#xD;
          -  Duration of infertility of ≥ 18 months and normal baseline ultrasonography&#xD;
&#xD;
          -  18 to 40 years of age&#xD;
&#xD;
          -  Tubal factor, male factor, polycystic ovary, unexplained infertility or combined&#xD;
             factors&#xD;
&#xD;
          -  Tubal factors&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Surgically-retrieved, frozen-thawed and pinpoint sperm or globozoospermia&#xD;
&#xD;
          -  Thin endometrium&#xD;
&#xD;
          -  Uterine anomaly and adhesion&#xD;
&#xD;
          -  Adenomyosis&#xD;
&#xD;
          -  Submucous myoma&#xD;
&#xD;
          -  Endometriosis&#xD;
&#xD;
          -  Severe medical condition&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Banon Assiut</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qena Fertility Center</name>
      <address>
        <city>Qena</city>
        <zip>123456</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IbnSina IVF Center</name>
      <address>
        <city>Sohag</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>June 9, 2020</last_update_submitted>
  <last_update_submitted_qc>June 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</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>Lab Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <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/NCT03823235
org study id: IbnSina-Humidity
nct id: NCT03823235
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Humidity for human embryo culture has been raised as essential with advantageous effect on
      clinical pregnancy and ongoing pregnancy after ICSI compared with a dry incubator. Whether
      the deleterious effect of dry culture would have an extended effect reaches the live birth
      rate needs to be examined. This RCT is to examine the effect of dry and humidified culture on
      live birth rates after ICSI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Live birth rate
time frame: 30 weeks
description: Viable neonate after 30 weeks of gestation per initiated cycle
measure: Cumulative live birth rate
time frame: One year
description: Viable neonate after 30 weeks of gestation after one fresh and/or one frozen-warmed transfer per initiated cycle
measure: Ongoing pregnancy rate
time frame: 12 weeks of gestation
description: Continued pregnancy after 12 weeks of gestation per initiated cycle
measure: Cumulative ongoing pregnancy rate
time frame: 12 weeks of gestation
description: Continued pregnancy after 12 weeks of gestation per initiated cycle within one year of randomization
measure: Clinical pregnancy rate
time frame: 7 weeks of gestation
description: Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle
measure: Cumulative clinical pregnancy rate
time frame: 7 weeks of gestation
description: Ultrasound detect heartbeat after 7 weeks of gestation per initiated cycle within one year of randomization
measure: Implantation rate
time frame: 7 weeks of gestation
description: Number of sacs with a heartbeat per number of embryo transferred
measure: Cumulative implantation rate
time frame: 7 weeks of gestation
description: Number of sacs with a heartbeat per number of embryo transferred within one year of randomization
measure: Ongoing implantation rate
time frame: 12 weeks of gestation
description: Number of sacs with a heartbeat per number of embryo transferred
measure: Cumulative ongoing implantation rate
time frame: 12 weeks of gestation
description: Number of sacs with a heartbeat per number of embryo transferred within one year of randomization
measure: Preterm birth rate
time frame: 37 weeks
description: number of babies born before 37 weeks of gestation per total birth
measure: Very preterm birth
time frame: 32 weeks
description: number of babies born before 32 weeks of gestation per total birth
measure: Low birth weight rate
time frame: 40 weeks of gestation
description: number of babies with < 2500 gm per total birth
measure: Fertilization rate
time frame: 6 days of culture
description: fertilized oocytes with two pronuclei per Metaphase II injected
measure: Cleavage rate
time frame: 6 days of culture
description: Cleaved embryo per fertilized oocyte
measure: Rate of high-quality day-3 embryos
time frame: 6 days of culture
description: Embryos with seven or eight blastomeres of appropriate-size, and < 10% fragmentation by volume per fertilized oocyte
measure: Blastocyst formation rate
time frame: 6 days of culture
description: Formed blastocyst on day 5/6 from fertilized oocytes
measure: Rate of high-quality blastocyst
time frame: 6 days of culture
description: Blastocysts ≥ 3.1.1 grade per fertilized oocyte
measure: Rate of utilizable blastocyst
time frame: 6 days of culture
description: Transferred and cryopreserved blastocysts from fertilized oocytes
arm group label: Culture of human embryo in non-humidified incubator
arm group type: Experimental
description: Embryo culture after in vitro fertilization in incubator with no humidity
arm group label: Culture of human embryo in humidified incubator
arm group type: No Intervention
description: Embryo culture after in vitro fertilization in incubator with humidity
intervention type: Other
intervention name: Human embryo culture
description: humidifed or dry incubator
arm group label: Culture of human embryo in non-humidified incubator
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
facility: 
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ibn Sina Hospital
investigator full name: Muhammad Fawzy
investigator title: Lab Director
mesh term: Infertility
sharing ipd: No