<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/NCT03825445</url>
  </required_header>
  <id_info>
    <org_study_id>H2016/205</org_study_id>
    <nct_id>NCT03825445</nct_id>
  </id_info>
  <brief_title>GnRH Agonist Versus hCG Trigger in Ovulation Induction With Intrauterine Insemination.</brief_title>
  <official_title>GnRH Agonist Versus hCG Trigger in Ovulation Induction With Intrauterine Insemination: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hue University of Medicine and Pharmacy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hue University of Medicine and Pharmacy</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>
      This study aims to compare clinical pregnancy rates (CPR) in patients who are administered&#xD;
      either Gonadotropin-releasing hormone agonists (GnRHa) or human chorionic gonadotropin (hCG)&#xD;
      for ovulation trigger in intrauterine insemination (IUI) cycles. A prospective randomized&#xD;
      comparative study was conducted at Hue University Hospital in Vietnam. Total of 197 infertile&#xD;
      women were randomly assigned to receive either GnRHa trigger (n=98 cycles) or hCG trigger (n=&#xD;
      99 cycles) for ovulation trigger. Patients returned for ultrasound monitoring 24 hours after&#xD;
      IUI to confirm ovulation. A clinical pregnancy was defined as the presence of gestational sac&#xD;
      with fetal cardiac activity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design A prospective randomized comparative study was conducted at Hue University&#xD;
      Hospital in Vietnam from April 2016 to June 2017 in 197 infertile women undergoing IUI. The&#xD;
      study was approved by the Ethics Committee at Hue University of Medicine and Pharmacy.&#xD;
&#xD;
      Study population A total of 217 women were recruited into the sample at the first stage.&#xD;
      Inclusion criteria were women with bilateral tubal patency, at least one follicle ≥ 18mm in&#xD;
      diameter on the day of trigger, and men with more than five millions total motile sperm after&#xD;
      preparation. Only the first cycles of IUI were studied and there were 197 infertile women who&#xD;
      obtained at least 1 mature follicle at the first cycle were included in analysis. Patients&#xD;
      were randomly assigned to receive either GnRHa trigger (n=98 cycles) or hCG trigger (n= 99&#xD;
      cycles) for ovulation trigger.&#xD;
&#xD;
      Intervention All patients included in the study were subjected to complete history and&#xD;
      physical. Patients with a history of abnormal menstrual cycles (amenorrhea, oligomenorrhea)&#xD;
      underwent ovarian stimulation. Stimulation was started on cycle day eight with 75 IU Menogon&#xD;
      (Ferring Pharm Co, Switzerland) daily. Ultrasound monitoring was required after every 2-3&#xD;
      days of stimulation and adjustments to dose and duration were tailed according the patient's&#xD;
      response. Ovulation was triggered when at least one and no more than 3 follicles reached&#xD;
      ≥18mm in diameter. Patients were then randomly assigned to receive either two doses of GnRH-a&#xD;
      (Fertipeptil 0.1mg x 2 vial; Ferring Pharm Co, Switzerland) or hCG (Pregnyl 5000IU; Organon&#xD;
      Pharm Co, Nertheland) for ovulation trigger.&#xD;
&#xD;
      IUI was then performed with sperm preparation by radiant centrifugation 36 hours after the&#xD;
      trigger. Luteal phase support with progesterone 200mg daily (Utrogestan; Besins Health Care&#xD;
      Com, Belgium) was started in the day of IUI.&#xD;
&#xD;
      Assessment of outcomes Patients returned for ultrasound monitoring 24 hours after IUI to&#xD;
      confirm ovulation which is determined by the accumulation of free fluid in peritoneum at&#xD;
      Douglas sac and disappearance of the previous mature follicles.&#xD;
&#xD;
      Serum β-human chorionic gonadotropin (βhCG) was collected 14 days after insemination. A&#xD;
      biochemical pregnancy was defined by βhCG concentration &gt; 25 mIU/ml (Shapphire 350; Cork Com,&#xD;
      Ireland). Two weeks after a positive βhCG test, the patient returned for an ultrasound&#xD;
      appointment. A clinical pregnancy was defined as the presence of gestational sac with fetal&#xD;
      cardiac activity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2016</start_date>
  <completion_date type="Actual">June 30, 2017</completion_date>
  <primary_completion_date type="Actual">June 30, 2017</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>
    <intervention_model_description>A prospective randomized comparative study was conducted at Hue University Hospital in Vietnam. Total of 197 infertile women were randomly assigned to receive either GnRHa trigger (n=98 cycles) or hCG trigger (n= 99 cycles) for ovulation trigger. Patients returned for ultrasound monitoring 24 hours after IUI to confirm ovulation.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Odd even rule</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The effectiveness of GnRHa versus hCG in ovulation induction</measure>
    <time_frame>14 months</time_frame>
    <description>To compare the ovulation rate of patients who were triggered with GnRHa versus hCG in patients undergoing either natural cycle or controlled ovarian stimulation with gonadotropins and IUI.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The effectiveness of GnRHa versus hCG in pregnancy rate</measure>
    <time_frame>14 months</time_frame>
    <description>To compare the pregnancy rate of patients who were triggered with GnRHa versus hCG in patients undergoing either natural cycle or controlled ovarian stimulation with gonadotropins and IUI.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">197</enrollment>
  <condition>Ovulation Induction</condition>
  <arm_group>
    <arm_group_label>GnRHa trigger</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infertile patients underwent ovarian stimulation, started on cycle day eight with 75 IU Menogon (Ferring Pharm Co, Switzerland) daily. Ultrasound monitoring was required after every 2-3 days of stimulation and adjustments to dose and duration were tailed according the patient's response. Ovulation was triggered when at least one and no more than 3 follicles reached ≥18mm in diameter. Patients were then randomly assigned to receive two doses of GnRH-a (Fertipeptil 0.1mg x 2 vial; Ferring Pharm Co, Switzerland) for ovulation trigger.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hCG trigger</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infertile patients underwent ovarian stimulation, started on cycle day eight with 75 IU Menogon (Ferring Pharm Co, Switzerland) daily. Ultrasound monitoring was required after every 2-3 days of stimulation and adjustments to dose and duration were tailed according the patient's response. Ovulation was triggered when at least one and no more than 3 follicles reached ≥18mm in diameter. Patients were then randomly assigned to receive hCG (Pregnyl 5000IU; Organon Pharm Co, Nertheland) for ovulation trigger.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GnRHa (Fertipeptil 0.1mg)</intervention_name>
    <description>Two doses of GnRH-a (Fertipeptil 0.1mg x 2 vial) for ovulation trigger after ovarian stimulation for IUI.</description>
    <arm_group_label>GnRHa trigger</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>hCG (Pregnyl 5000IU)</intervention_name>
    <description>hCG (Pregnyl 5000IU) for ovulation trigger after ovarian stimulation for IUI.</description>
    <arm_group_label>hCG trigger</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infertile women who were indicated for IUI cycles&#xD;
&#xD;
          -  bilateral tubal patency&#xD;
&#xD;
          -  at least one follicle ≥ 18mm in diameter on the day of trigger, and&#xD;
&#xD;
          -  men with more than five millions total motile sperm after preparation.&#xD;
&#xD;
          -  Only the first cycles of IUI were studied&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No mature follicle&#xD;
&#xD;
          -  Disagree to be enrolled&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Infertile women with ovulation stimulation</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Minh Tam Le, Prof.MD.PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hue University of Medicine and Pharmacy, Hue University</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 30, 2019</last_update_submitted>
  <last_update_submitted_qc>January 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GnRH agonist trigger</keyword>
  <keyword>hCG trigger</keyword>
  <keyword>ovulation induction</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chorionic Gonadotropin</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/NCT03825445
org study id: H2016/205
nct id: NCT03825445
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study aims to compare clinical pregnancy rates (CPR) in patients who are administered
      either Gonadotropin-releasing hormone agonists (GnRHa) or human chorionic gonadotropin (hCG)
      for ovulation trigger in intrauterine insemination (IUI) cycles. A prospective randomized
      comparative study was conducted at Hue University Hospital in Vietnam. Total of 197 infertile
      women were randomly assigned to receive either GnRHa trigger (n=98 cycles) or hCG trigger (n=
      99 cycles) for ovulation trigger. Patients returned for ultrasound monitoring 24 hours after
      IUI to confirm ovulation. A clinical pregnancy was defined as the presence of gestational sac
      with fetal cardiac activity.
Study design A prospective randomized comparative study was conducted at Hue University
      Hospital in Vietnam from April 2016 to June 2017 in 197 infertile women undergoing IUI. The
      study was approved by the Ethics Committee at Hue University of Medicine and Pharmacy.

      Study population A total of 217 women were recruited into the sample at the first stage.
      Inclusion criteria were women with bilateral tubal patency, at least one follicle ≥ 18mm in
      diameter on the day of trigger, and men with more than five millions total motile sperm after
      preparation. Only the first cycles of IUI were studied and there were 197 infertile women who
      obtained at least 1 mature follicle at the first cycle were included in analysis. Patients
      were randomly assigned to receive either GnRHa trigger (n=98 cycles) or hCG trigger (n= 99
      cycles) for ovulation trigger.

      Intervention All patients included in the study were subjected to complete history and
      physical. Patients with a history of abnormal menstrual cycles (amenorrhea, oligomenorrhea)
      underwent ovarian stimulation. Stimulation was started on cycle day eight with 75 IU Menogon
      (Ferring Pharm Co, Switzerland) daily. Ultrasound monitoring was required after every 2-3
      days of stimulation and adjustments to dose and duration were tailed according the patient's
      response. Ovulation was triggered when at least one and no more than 3 follicles reached
      ≥18mm in diameter. Patients were then randomly assigned to receive either two doses of GnRH-a
      (Fertipeptil 0.1mg x 2 vial; Ferring Pharm Co, Switzerland) or hCG (Pregnyl 5000IU; Organon
      Pharm Co, Nertheland) for ovulation trigger.

      IUI was then performed with sperm preparation by radiant centrifugation 36 hours after the
      trigger. Luteal phase support with progesterone 200mg daily (Utrogestan; Besins Health Care
      Com, Belgium) was started in the day of IUI.

      Assessment of outcomes Patients returned for ultrasound monitoring 24 hours after IUI to
      confirm ovulation which is determined by the accumulation of free fluid in peritoneum at
      Douglas sac and disappearance of the previous mature follicles.

      Serum β-human chorionic gonadotropin (βhCG) was collected 14 days after insemination. A
      biochemical pregnancy was defined by βhCG concentration > 25 mIU/ml (Shapphire 350; Cork Com,
      Ireland). Two weeks after a positive βhCG test, the patient returned for an ultrasound
      appointment. A clinical pregnancy was defined as the presence of gestational sac with fetal
      cardiac activity.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A prospective randomized comparative study was conducted at Hue University Hospital in Vietnam. Total of 197 infertile women were randomly assigned to receive either GnRHa trigger (n=98 cycles) or hCG trigger (n= 99 cycles) for ovulation trigger. Patients returned for ultrasound monitoring 24 hours after IUI to confirm ovulation.
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Odd even rule
measure: The effectiveness of GnRHa versus hCG in ovulation induction
time frame: 14 months
description: To compare the ovulation rate of patients who were triggered with GnRHa versus hCG in patients undergoing either natural cycle or controlled ovarian stimulation with gonadotropins and IUI.
measure: The effectiveness of GnRHa versus hCG in pregnancy rate
time frame: 14 months
description: To compare the pregnancy rate of patients who were triggered with GnRHa versus hCG in patients undergoing either natural cycle or controlled ovarian stimulation with gonadotropins and IUI.
arm group label: GnRHa trigger
arm group type: Experimental
description: Infertile patients underwent ovarian stimulation, started on cycle day eight with 75 IU Menogon (Ferring Pharm Co, Switzerland) daily. Ultrasound monitoring was required after every 2-3 days of stimulation and adjustments to dose and duration were tailed according the patient's response. Ovulation was triggered when at least one and no more than 3 follicles reached ≥18mm in diameter. Patients were then randomly assigned to receive two doses of GnRH-a (Fertipeptil 0.1mg x 2 vial; Ferring Pharm Co, Switzerland) for ovulation trigger.
arm group label: hCG trigger
arm group type: Experimental
description: Infertile patients underwent ovarian stimulation, started on cycle day eight with 75 IU Menogon (Ferring Pharm Co, Switzerland) daily. Ultrasound monitoring was required after every 2-3 days of stimulation and adjustments to dose and duration were tailed according the patient's response. Ovulation was triggered when at least one and no more than 3 follicles reached ≥18mm in diameter. Patients were then randomly assigned to receive hCG (Pregnyl 5000IU; Organon Pharm Co, Nertheland) for ovulation trigger.
intervention type: Drug
intervention name: GnRHa (Fertipeptil 0.1mg)
description: Two doses of GnRH-a (Fertipeptil 0.1mg x 2 vial) for ovulation trigger after ovarian stimulation for IUI.
arm group label: GnRHa trigger
intervention type: Drug
intervention name: hCG (Pregnyl 5000IU)
description: hCG (Pregnyl 5000IU) for ovulation trigger after ovarian stimulation for IUI.
arm group label: hCG trigger
criteria: 
gender: Female
gender based: Yes
gender description: Infertile women with ovulation stimulation
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Minh Tam Le, Prof.MD.PhD
role: Study Director
affiliation: Hue University of Medicine and Pharmacy, Hue University
responsible party type: Sponsor
mesh term: Chorionic Gonadotropin