<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/NCT01674283</url>
  </required_header>
  <id_info>
    <org_study_id>OVO-12-08</org_study_id>
    <nct_id>NCT01674283</nct_id>
  </id_info>
  <brief_title>Effect of Glucagon on Uterine Contractility at the Time of Embryo Transfer in in Vitro Fertilization</brief_title>
  <official_title>Effect of Glucagon on Uterine Contractility at the Time of Embryo Transfer in in Vitro Fertilization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinique Ovo</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinique Ovo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The success of in vitro fertilization is based mainly on uterine implantation embryo. An&#xD;
      excessive uterine contractility may interfere with implantation by a movement of the embryo&#xD;
      in the uterus. The inhibition of the uterine contractility may have a positive effect on&#xD;
      success rate of in vitro fertilization. It is through parenteral injection of glucagon and&#xD;
      its spasmolytic effect on various smooth muscles and thereby on the uterine muscle, at the&#xD;
      time of embryo transfer, the investigators intend to improve the pregnancy rates obtained&#xD;
      after IVF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women will have a cycle of in vitro fertilization (IVF) and follow the standard protocol&#xD;
      established by the clinic ovo or the fertility clinic of CHUM. On the day of embryo transfer,&#xD;
      the investigators will administer 1 mg of Glucagon or placebo intramuscularly 10 minutes&#xD;
      before the embryo transfer. The uterine contractility will be measured by ultrasound before&#xD;
      and after injection to document the impact of Glucagon on it and we will proceed to embryo&#xD;
      transfer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Uterine contractility not possible to visualize with our ultrasound machines&#xD;
  </why_stopped>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <phase>Phase 4</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>Uterine muscle relaxation</measure>
    <time_frame>30 minutes</time_frame>
    <description>Determine if the intramuscular administration of 1mg of Glucagon 10 minutes before the embryo transfer is associated with a uterine muscle relaxation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Embryo implantation and pregnancy rate</measure>
    <time_frame>7 weeks</time_frame>
    <description>Determine if the intramuscular administration of 1mg of Glucagon 10 minutes before the embryo transfer is associated with higher implantation and pregnancy rates than during embryo transfer without glucagon.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Women With Fertility Disorder</condition>
  <arm_group>
    <arm_group_label>Glucagon</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The first recording is a transvaginal ultrasound in midsagittale position for the measurement of the basic uterine contractility 2 minutes before the injection of Glucagon.&#xD;
The second recording is doing the same way 10 minutes after the Glucagon injection, just before the embryo transfer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sodium chloride 0.9%</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The first recording is a transvaginal ultrasound in midsagittale position for the measurement of the basic uterine contractility 2 minutes before the injection of the placebo.&#xD;
The second recording is doing the same way 10 minutes after the placebo injection, just before the embryo transfer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glucagon</intervention_name>
    <arm_group_label>Glucagon</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>Sodium chloride 0.9%</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women doing fertility treatment at the clinic ovo or fertility clinic of CHUM&#xD;
&#xD;
          -  Less than 40 years old&#xD;
&#xD;
          -  Women with stimulate in vitro fertilization cycle&#xD;
&#xD;
          -  Women able to give her consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body mass index &gt; 35 kg/m2&#xD;
&#xD;
          -  Women with diabetes&#xD;
&#xD;
          -  Women with hypertensive disorders&#xD;
&#xD;
          -  Women with a blood pressure greater or equal to 140/90 mmHg at the randomization visit&#xD;
&#xD;
          -  Cons-indication to taking Glucagon:&#xD;
&#xD;
               -  Hypersensitivity to product&#xD;
&#xD;
               -  Pheochromocytoma or history of pheochromocytoma&#xD;
&#xD;
               -  Insulinoma&#xD;
&#xD;
               -  Taking a beta-blocker (drug interactions)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Himaya, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>clinique ovo and CHUM</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinique Ovo</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4P 2S4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <last_update_submitted>July 24, 2015</last_update_submitted>
  <last_update_submitted_qc>July 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glucagon</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01674283
org study id: OVO-12-08
nct id: NCT01674283
lead sponsor: 
has dmc: No
The success of in vitro fertilization is based mainly on uterine implantation embryo. An
      excessive uterine contractility may interfere with implantation by a movement of the embryo
      in the uterus. The inhibition of the uterine contractility may have a positive effect on
      success rate of in vitro fertilization. It is through parenteral injection of glucagon and
      its spasmolytic effect on various smooth muscles and thereby on the uterine muscle, at the
      time of embryo transfer, the investigators intend to improve the pregnancy rates obtained
      after IVF.
Women will have a cycle of in vitro fertilization (IVF) and follow the standard protocol
      established by the clinic ovo or the fertility clinic of CHUM. On the day of embryo transfer,
      the investigators will administer 1 mg of Glucagon or placebo intramuscularly 10 minutes
      before the embryo transfer. The uterine contractility will be measured by ultrasound before
      and after injection to document the impact of Glucagon on it and we will proceed to embryo
      transfer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Uterine muscle relaxation
time frame: 30 minutes
description: Determine if the intramuscular administration of 1mg of Glucagon 10 minutes before the embryo transfer is associated with a uterine muscle relaxation.
measure: Embryo implantation and pregnancy rate
time frame: 7 weeks
description: Determine if the intramuscular administration of 1mg of Glucagon 10 minutes before the embryo transfer is associated with higher implantation and pregnancy rates than during embryo transfer without glucagon.
arm group label: Glucagon
arm group type: Experimental
description: The first recording is a transvaginal ultrasound in midsagittale position for the measurement of the basic uterine contractility 2 minutes before the injection of Glucagon.
The second recording is doing the same way 10 minutes after the Glucagon injection, just before the embryo transfer.
arm group label: Sodium chloride 0.9%
arm group type: Placebo Comparator
description: The first recording is a transvaginal ultrasound in midsagittale position for the measurement of the basic uterine contractility 2 minutes before the injection of the placebo.
The second recording is doing the same way 10 minutes after the placebo injection, just before the embryo transfer.
intervention type: Drug
intervention name: Glucagon
arm group label: Glucagon
intervention type: Drug
intervention name: placebo
arm group label: Sodium chloride 0.9%
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Eric Himaya, Dr
role: Principal Investigator
affiliation: clinique ovo and CHUM
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Glucagon