<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/NCT01706900</url>
  </required_header>
  <id_info>
    <org_study_id>IbnSina Hospital</org_study_id>
    <nct_id>NCT01706900</nct_id>
  </id_info>
  <brief_title>Incubator Temperature for Culturing Human Embryos</brief_title>
  <official_title>Incubator Temperature for Culturing Human Embryos</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ibn Sina Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ibn Sina Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Incubator temperature is one of the most precious variables in IVF labs. When the IVF&#xD;
      started, almost all incubator temperatures were set at 37 degrees which mimic in vivo&#xD;
      conditions. Some authors speculated that gametes and early embryos might need low&#xD;
      temperatures that provide quieter metabolism. We decide to compare Embryo culture at 37&#xD;
      degree or slightly lower 36.5 degree and extensively investigate to find which is better to&#xD;
      crucially introduce a solid evidence through this RCT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Since the first IVF birth in 1978, the field of assisted reproductive technology has evolved&#xD;
      dramatically. The evolution includes both the ovarian stimulation protocols and the&#xD;
      laboratory techniques. Optimization of the laboratory procedures is of great interest to the&#xD;
      scientists in the field of IVF.&#xD;
&#xD;
      Incubator temperature is one of the most precious variables in IVF labs. When the IVF&#xD;
      started, almost all incubator temperatures were set at 37 degrees which mimic in vivo&#xD;
      conditions.&#xD;
&#xD;
      Some authors speculated that gametes and early embryos might need low temperatures that&#xD;
      provide quieter metabolism. another group found increase in pregnancy rate for embryos&#xD;
      cultured below 37 degree compared to those cultured at 37 degree. Nevertheless; the majority&#xD;
      of embryologists still consider culture at 37 degrees is the back bone for the incubators.&#xD;
&#xD;
      The paucity of well designed studies makes it difficult to achieve a satisfactory answer&#xD;
      whether lower temperature will improve the pregnancy rate. This encourage us to study the&#xD;
      effect of lower temperature (36.5 degrees) on the pregnancy rate compared to conventional&#xD;
      temperature (37 degrees).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 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>Fetal heart beat rate</measure>
    <time_frame>3 months</time_frame>
    <description>Compare the fetal heart beat rate between the 2 study arms in the first 3 months following Embryo Transfer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pregnancy rate</measure>
    <time_frame>one month</time_frame>
    <description>Measure the pregnancy rate between the 2 study arms in the following one month after Embryo Transfer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Top quality embryos Day3</measure>
    <time_frame>one week</time_frame>
    <description>Measure the top quality embryos day3 between the 2 study arms in the following week after ICSI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blastocyst formation rate</measure>
    <time_frame>one week</time_frame>
    <description>Measure the blastocyst formation rate between the 2 study arms in the following week after ICSI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Top quality blastocyst</measure>
    <time_frame>one week</time_frame>
    <description>Measure the top quality blastocyst rate between the 2 study arms in the following week after ICSI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implantation rate</measure>
    <time_frame>one month</time_frame>
    <description>Measure the implantation rate between the 2 study arms in the following first month after Embryo Transfer</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cleavage rate on day 3</measure>
    <time_frame>one month</time_frame>
    <description>We will measure the rate of embryo cleavage on day3 between the 2 study arms</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Embryo Culture</condition>
  <arm_group>
    <arm_group_label>Incubator Temp 37 degree</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>We will set incubator Temp to 37 degree as the routine embryo culture Temp since 1978 as the placebo arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Incubator Temp set to 36.5 degree</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>We will set incubator Temp to 36.5 so we can assess the outcome and compare the results with the placebo group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Incubator Temp set to 36.5 degree</intervention_name>
    <description>We will set incubator Temp to 36.5 so we can assess the outcome and compare the results with the placebo group.</description>
    <arm_group_label>Incubator Temp set to 36.5 degree</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Incubator Temp 37 degree</intervention_name>
    <description>We will set incubator Temp to 37 degree as the routine embryo culture Temp since 1978 as the placebo arm.</description>
    <arm_group_label>Incubator Temp 37 degree</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged ≤ 33 years&#xD;
&#xD;
          -  BMI ≤ 33&#xD;
&#xD;
          -  Normal responder ( ≥ 8 MII )&#xD;
&#xD;
          -  Fresh cycle&#xD;
&#xD;
          -  First attempt (or with previous successful attempt)&#xD;
&#xD;
          -  Normal or mild oligoasthenoteratozoospermia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Testicular sperm&#xD;
&#xD;
          -  &lt; 8 MIII collected&#xD;
&#xD;
          -  Difficult transfer cycle&#xD;
&#xD;
          -  endometriotic patients&#xD;
&#xD;
          -  Poor Endometrium &lt; 8mm diameter at OPU&#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>Mohamed Y. Abdel-Rahman, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>IbnSina IVF center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hesham A. Kasem, Gynaecologist</last_name>
    <role>Principal Investigator</role>
    <affiliation>IbnSina IVF Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IbnSina IVF Center, IbnSina Hospital</name>
      <address>
        <city>Sohag</city>
        <zip>12345</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 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/NCT01706900
org study id: IbnSina Hospital
nct id: NCT01706900
lead sponsor: 
has dmc: Yes
Incubator temperature is one of the most precious variables in IVF labs. When the IVF
      started, almost all incubator temperatures were set at 37 degrees which mimic in vivo
      conditions. Some authors speculated that gametes and early embryos might need low
      temperatures that provide quieter metabolism. We decide to compare Embryo culture at 37
      degree or slightly lower 36.5 degree and extensively investigate to find which is better to
      crucially introduce a solid evidence through this RCT.
Since the first IVF birth in 1978, the field of assisted reproductive technology has evolved
      dramatically. The evolution includes both the ovarian stimulation protocols and the
      laboratory techniques. Optimization of the laboratory procedures is of great interest to the
      scientists in the field of IVF.

      Incubator temperature is one of the most precious variables in IVF labs. When the IVF
      started, almost all incubator temperatures were set at 37 degrees which mimic in vivo
      conditions.

      Some authors speculated that gametes and early embryos might need low temperatures that
      provide quieter metabolism. another group found increase in pregnancy rate for embryos
      cultured below 37 degree compared to those cultured at 37 degree. Nevertheless; the majority
      of embryologists still consider culture at 37 degrees is the back bone for the incubators.

      The paucity of well designed studies makes it difficult to achieve a satisfactory answer
      whether lower temperature will improve the pregnancy rate. This encourage us to study the
      effect of lower temperature (36.5 degrees) on the pregnancy rate compared to conventional
      temperature (37 degrees).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
measure: Fetal heart beat rate
time frame: 3 months
description: Compare the fetal heart beat rate between the 2 study arms in the first 3 months following Embryo Transfer.
measure: Pregnancy rate
time frame: one month
description: Measure the pregnancy rate between the 2 study arms in the following one month after Embryo Transfer
measure: Top quality embryos Day3
time frame: one week
description: Measure the top quality embryos day3 between the 2 study arms in the following week after ICSI
measure: blastocyst formation rate
time frame: one week
description: Measure the blastocyst formation rate between the 2 study arms in the following week after ICSI
measure: Top quality blastocyst
time frame: one week
description: Measure the top quality blastocyst rate between the 2 study arms in the following week after ICSI
measure: Implantation rate
time frame: one month
description: Measure the implantation rate between the 2 study arms in the following first month after Embryo Transfer
measure: Cleavage rate on day 3
time frame: one month
description: We will measure the rate of embryo cleavage on day3 between the 2 study arms
arm group label: Incubator Temp 37 degree
arm group type: Placebo Comparator
description: We will set incubator Temp to 37 degree as the routine embryo culture Temp since 1978 as the placebo arm.
arm group label: Incubator Temp set to 36.5 degree
arm group type: Experimental
description: We will set incubator Temp to 36.5 so we can assess the outcome and compare the results with the placebo group.
intervention type: Other
intervention name: Incubator Temp set to 36.5 degree
description: We will set incubator Temp to 36.5 so we can assess the outcome and compare the results with the placebo group.
arm group label: Incubator Temp set to 36.5 degree
intervention type: Other
intervention name: Incubator Temp 37 degree
description: We will set incubator Temp to 37 degree as the routine embryo culture Temp since 1978 as the placebo arm.
arm group label: Incubator Temp 37 degree
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: Mohamed Y. Abdel-Rahman, M.D.
role: Principal Investigator
affiliation: IbnSina IVF center
last name: Hesham A. Kasem, Gynaecologist
role: Principal Investigator
affiliation: IbnSina IVF Center
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ibn Sina Hospital
investigator full name: Muhammad Fawzy
investigator title: IVF Laboratory Director