<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/NCT03263299</url>
  </required_header>
  <id_info>
    <org_study_id>8</org_study_id>
    <nct_id>NCT03263299</nct_id>
  </id_info>
  <brief_title>Value of Cabergoline and Low Dose Aspirin in Poor Responders Undergoing ICSI-ET With GnRH Agonist Flare-Up-Protocol</brief_title>
  <official_title>Value of Cabergoline and Low Dose Aspirin in Poor Responders Undergoing ICSI-ET Using Microdose GnRH Agonist Flare-Up-Protocol</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ovarian stimulation will be done using the Microdose flare-up regimen. The patient will&#xD;
      receive diluted doses of the GnRH agonist leuprolide acetate 40 µg, given subcutaneously&#xD;
      twice daily. Two days later, stimulation will be initiated by intramuscular (IM) injections&#xD;
      of HMG (Merional, IBSA, Germany) in a dose of 300 IU/day.&#xD;
&#xD;
      Follicular monitoring began from the ninth day of the cycle by serial vaginal ultrasonography&#xD;
      and measurement of serum E2 levels. IM injections of 10000 IU HCG (Choriomon; IBSA, Germany)&#xD;
      will be injected when at least 2 follicles 18 mm were observed on ultrasonography.&#xD;
&#xD;
      Oocytes willbe retrieved 36 hours after hCG injection using a 17-gauge aspiration needle&#xD;
      under transvaginal ultrasound guidance. The pelvis is evaluated with ultrasound to ensure&#xD;
      that there is no internal bleeding.&#xD;
&#xD;
      After fertilization was confirmed when two polar bodies and two pronuclear were observed&#xD;
      18-20 hours after insemination, one to three grade A embryos were transferred at day 3&#xD;
      fertilization.&#xD;
&#xD;
      The luteal phase support will be initiated from the day of oocyte retrieval for all patients&#xD;
      with (Cyclogest 400 mg, Actavis pharmaceutical, UK) vaginal suppositories per day till the&#xD;
      day of serum pregnancy test was done.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ovarian stimulation was done using the Microdose flare-up regimen. The patient received&#xD;
      diluted doses of the GnRH agonist leuprolide acetate 40 µg, given subcutaneously twice daily.&#xD;
      Two days later, stimulation is initiated by intramuscular (IM) injections of HMG (Merional,&#xD;
      IBSA, Germany) in a dose of 300 IU/day.&#xD;
&#xD;
      Follicular monitoring began from the ninth day of the cycle by serial vaginal ultrasonography&#xD;
      and measurement of serum E2 levels. IM injections of 10000 IU HCG (Choriomon; IBSA, Germany)&#xD;
      were injected when at least 2 follicles 18 mm were observed on ultrasonography.&#xD;
&#xD;
      Oocytes were retrieved 36 hours after hCG injection using a 17-gauge aspiration needle under&#xD;
      transvaginal ultrasound guidance. The pelvis is evaluated with ultrasound to ensure that&#xD;
      there is no internal bleeding.&#xD;
&#xD;
      After fertilization was confirmed when two polar bodies and two pronuclear were observed&#xD;
      18-20 hours after insemination, one to three grade A embryos were transferred at day 3&#xD;
      fertilization.&#xD;
&#xD;
      The luteal phase support was initiated from the day of oocyte retrieval for all patients with&#xD;
      (Cyclogest 400 mg, Actavis pharmaceutical, UK) vaginal suppositories per day till the day of&#xD;
      serum pregnancy test was done.&#xD;
&#xD;
      Serum β-hCG was performed 14 days after the embryo transfer to confirm chemical pregnancy.&#xD;
      Clinical pregnancy was confirmed when there was an evidence of gestational sac, embryo and&#xD;
      fetal heart activity at time of transvaginal ultrasound evaluation by the 6th week.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2017</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">August 2018</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical pregnancy</measure>
    <time_frame>4 weeks after embryo transfer</time_frame>
    <description>Intrauterine gestational sac detection by transvaginal ultrasound</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Invitro Fertilization</condition>
  <arm_group>
    <arm_group_label>cabergoline group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>received cabergoline in addition to aspirin. Cabergoline was administered in a dose of 1 mg/week in two divided doses which was terminated after embryo transfer. Aspirin was administered in daily dose of 80 mg initiated at the start of down-regulation with luteal leuprolide</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aspirin group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Aspirin was administered in daily dose of 80 mg initiated at the start of down-regulation with luteal leuprolide</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GnRH Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Microdose flare-up regimen. The patient received diluted doses of the GnRH agonist leuprolide acetate 40 µg, given subcutaneously twice daily. Two days later, stimulation is initiated by intramuscular (IM) injections of HMG (Merional, IBSA, Germany) in a dose of 300 IU/day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>cabergoline</intervention_name>
    <description>Cabergoline was administered in a dose of 1 mg/week in two divided doses which was terminated after embryo transfer</description>
    <arm_group_label>cabergoline group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <description>Aspirin was administered in daily dose of 80 mg initiated at the start of down-regulation with luteal leuprolide</description>
    <arm_group_label>Aspirin group</arm_group_label>
    <arm_group_label>cabergoline group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GnRH agonist</intervention_name>
    <description>Microdose flare-up regimen. The patient received diluted doses of the GnRH agonist leuprolide acetate 40 µg, given subcutaneously twice daily. Two days later, stimulation is initiated by intramuscular (IM) injections of HMG (Merional, IBSA, Germany) in a dose of 300 IU/day.</description>
    <arm_group_label>Aspirin group</arm_group_label>
    <arm_group_label>GnRH Group</arm_group_label>
    <arm_group_label>cabergoline group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with a history of one or more failed IVF cycles with three or less retrieved&#xD;
             oocytes&#xD;
&#xD;
          2. No age limitation&#xD;
&#xD;
          3. Patients with an inadequate ovarian response in previous cycle&#xD;
&#xD;
          4. Low estradiol (E2) levels in response to ovarian stimulation in previous cycle&#xD;
&#xD;
          5. Lower number of retrieved oocytes in previous trials.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe male factor (azospermia)&#xD;
&#xD;
          2. Hydrosalpinx&#xD;
&#xD;
          3. History of endometriosis&#xD;
&#xD;
          4. Endocrine or metabolic disorders&#xD;
&#xD;
          5. Follicle stimulating hormone (FSH) level &gt; 15 mIU.&#xD;
&#xD;
          6. Antimullerian hormone (AMH)&lt; 0.5 ng/ml&#xD;
&#xD;
          7. Any uterine causes of infertility e.g. septate uterus&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Maged, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>kasr Alainy medical school</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed Maged, MD</last_name>
    <phone>01005227404</phone>
    <email>prof.ahmedmaged@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ayman Hany, MD</last_name>
    <email>aymanobgyn@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kasr Alainy medical school</name>
      <address>
        <city>Cairo</city>
        <zip>12151</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Maged</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Cabergoline</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/NCT03263299
org study id: 8
nct id: NCT03263299
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Ovarian stimulation will be done using the Microdose flare-up regimen. The patient will
      receive diluted doses of the GnRH agonist leuprolide acetate 40 µg, given subcutaneously
      twice daily. Two days later, stimulation will be initiated by intramuscular (IM) injections
      of HMG (Merional, IBSA, Germany) in a dose of 300 IU/day.

      Follicular monitoring began from the ninth day of the cycle by serial vaginal ultrasonography
      and measurement of serum E2 levels. IM injections of 10000 IU HCG (Choriomon; IBSA, Germany)
      will be injected when at least 2 follicles 18 mm were observed on ultrasonography.

      Oocytes willbe retrieved 36 hours after hCG injection using a 17-gauge aspiration needle
      under transvaginal ultrasound guidance. The pelvis is evaluated with ultrasound to ensure
      that there is no internal bleeding.

      After fertilization was confirmed when two polar bodies and two pronuclear were observed
      18-20 hours after insemination, one to three grade A embryos were transferred at day 3
      fertilization.

      The luteal phase support will be initiated from the day of oocyte retrieval for all patients
      with (Cyclogest 400 mg, Actavis pharmaceutical, UK) vaginal suppositories per day till the
      day of serum pregnancy test was done.
Ovarian stimulation was done using the Microdose flare-up regimen. The patient received
      diluted doses of the GnRH agonist leuprolide acetate 40 µg, given subcutaneously twice daily.
      Two days later, stimulation is initiated by intramuscular (IM) injections of HMG (Merional,
      IBSA, Germany) in a dose of 300 IU/day.

      Follicular monitoring began from the ninth day of the cycle by serial vaginal ultrasonography
      and measurement of serum E2 levels. IM injections of 10000 IU HCG (Choriomon; IBSA, Germany)
      were injected when at least 2 follicles 18 mm were observed on ultrasonography.

      Oocytes were retrieved 36 hours after hCG injection using a 17-gauge aspiration needle under
      transvaginal ultrasound guidance. The pelvis is evaluated with ultrasound to ensure that
      there is no internal bleeding.

      After fertilization was confirmed when two polar bodies and two pronuclear were observed
      18-20 hours after insemination, one to three grade A embryos were transferred at day 3
      fertilization.

      The luteal phase support was initiated from the day of oocyte retrieval for all patients with
      (Cyclogest 400 mg, Actavis pharmaceutical, UK) vaginal suppositories per day till the day of
      serum pregnancy test was done.

      Serum β-hCG was performed 14 days after the embryo transfer to confirm chemical pregnancy.
      Clinical pregnancy was confirmed when there was an evidence of gestational sac, embryo and
      fetal heart activity at time of transvaginal ultrasound evaluation by the 6th week.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: clinical pregnancy
time frame: 4 weeks after embryo transfer
description: Intrauterine gestational sac detection by transvaginal ultrasound
arm group label: cabergoline group
arm group type: Active Comparator
description: received cabergoline in addition to aspirin. Cabergoline was administered in a dose of 1 mg/week in two divided doses which was terminated after embryo transfer. Aspirin was administered in daily dose of 80 mg initiated at the start of down-regulation with luteal leuprolide
arm group label: Aspirin group
arm group type: Active Comparator
description: Aspirin was administered in daily dose of 80 mg initiated at the start of down-regulation with luteal leuprolide
arm group label: GnRH Group
arm group type: Active Comparator
description: Microdose flare-up regimen. The patient received diluted doses of the GnRH agonist leuprolide acetate 40 µg, given subcutaneously twice daily. Two days later, stimulation is initiated by intramuscular (IM) injections of HMG (Merional, IBSA, Germany) in a dose of 300 IU/day.
intervention type: Drug
intervention name: cabergoline
description: Cabergoline was administered in a dose of 1 mg/week in two divided doses which was terminated after embryo transfer
arm group label: cabergoline group
intervention type: Drug
intervention name: Aspirin
description: Aspirin was administered in daily dose of 80 mg initiated at the start of down-regulation with luteal leuprolide
arm group label: Aspirin group
arm group label: cabergoline group
intervention type: Drug
intervention name: GnRH agonist
description: Microdose flare-up regimen. The patient received diluted doses of the GnRH agonist leuprolide acetate 40 µg, given subcutaneously twice daily. Two days later, stimulation is initiated by intramuscular (IM) injections of HMG (Merional, IBSA, Germany) in a dose of 300 IU/day.
arm group label: Aspirin group
arm group label: GnRH Group
arm group label: cabergoline group
criteria: 
gender: Female
gender based: Yes
minimum age: 20 Years
maximum age: 39 Years
healthy volunteers: No
last name: Ahmed Maged, MD
role: Principal Investigator
affiliation: kasr Alainy medical school
last name: Ahmed Maged, MD
phone: 01005227404
email: prof.ahmedmaged@gmail.com
last name: Ayman Hany, MD
email: aymanobgyn@gmail.com
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Maged
investigator title: Professor
mesh term: Aspirin
mesh term: Cabergoline