<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/NCT03039049</url>
  </required_header>
  <id_info>
    <org_study_id>02053779</org_study_id>
    <nct_id>NCT03039049</nct_id>
  </id_info>
  <brief_title>GNRH Agonist Trigger and Modified Luteal Phase Adding a Bolus of GnRHa at the Time of Implantation: a RCT</brief_title>
  <official_title>GnRH Agonist Trigger and Modified Luteal Phase Support, Adding a Mid-luteal Bolus of GnRHa: a Randomised Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Ibn Rochd</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Ibn Rochd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose:The aim of this project is to prospectively determine whether a single dose of&#xD;
      GnRH-agonist administered at the time of implantation increases or not the reproductive&#xD;
      outcome in patients undergoing in vitro fertilization ( IVF)/ intracytoplasmatic sperm&#xD;
      injection(ICSI) triggered by a GnRH-agonist followed by a small bolus of human chorionic&#xD;
      gonadotropin (hCG 1500 IU) the day of oocyte retrieval.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It has been reported in previous publications that the ovarian hyperstimulation syndrome&#xD;
      (OHSS) was eliminated when GnRH agonist was used to trigger ovulation and the delivery rate&#xD;
      has improved after modified luteal support especially when a small bolus of hCG is used on&#xD;
      the day of oocyte retrieval. (OMEGA/HCG 1500 IU).&#xD;
&#xD;
      However, a risk difference of 7% in delivery rates is still in favor of HCG trigger. Thus,&#xD;
      further modifications in the luteal phase supplementation are required in order to optimise&#xD;
      the reproductive outcome after GnRH-agonist triggering.&#xD;
&#xD;
      Recently, many papers showed, that independently of the GnRH analogue used to prevent the&#xD;
      premature LH surge, the addition of GnRH-agonist during the luteal phase seems to be&#xD;
      beneficial in terms of pregnancy. Nevertheless, their use in practice is not yet admitted&#xD;
      because of controversial results in terms of efficacy and safety particularly on the&#xD;
      conceptus.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>Phase 3</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>implantation rate</measure>
    <time_frame>Time Frame: 5 weeks after IVF/ICSI</time_frame>
    <description>number of gestational sacs per number of embryos transferred</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>positive pregnancy test</measure>
    <time_frame>Time Frame: 2 weeks after IVF/ICSI</time_frame>
    <description>confirmed by beta-hCG 14 days post embryo transfer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ongoing pregnancy</measure>
    <time_frame>Time Frame: 12 weeks after IVF/ICSI</time_frame>
    <description>presence of foetal heart beat at 12 weeks of gestation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delivery rate</measure>
    <time_frame>Time Frame: 26 weeks after IVF/ICSI</time_frame>
    <description>birth of baby beyond 26 weeks of gestation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early pregnancy loss</measure>
    <time_frame>Time Frame: miscarriage before 5 weeks of gestation</time_frame>
    <description>loss of embryo before 5 weeks of gestation, chemical pregnancy and extra-uterine pregnancy</description>
  </secondary_outcome>
  <other_outcome>
    <measure>ovarian hyperstimulation syndrome OHSS</measure>
    <time_frame>Time Frame: from date of triggering until 2 weeks after pregnancy test]</time_frame>
    <description>early and late onset Ovarian hyper stimulation syndrome</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">328</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>GnRH agonist</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Triptorelin 0.1mg Triptorelin 0.1 mg administered subcutaneously 6 days after ovum pick-up (OPU) in IVF/ICSI cycles triggered by triptorelin 0.2 mg.&#xD;
Other Names:&#xD;
• Decapeptyl 0.1 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triptorelin 0.1 mg</intervention_name>
    <description>a single dose of Triptorelin 0.1 mg subcutaneously administered 6 days after oocyte retrieval.</description>
    <arm_group_label>GnRH agonist</arm_group_label>
    <other_name>Decapeptyl 0.1 mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Female age &lt; 40 years No uterine (fibroids, mullerian malformations), ovarian (&#xD;
        endometrioma) or adnexa (hydrosalpinx) abnormalities• Baseline FSH and LH &lt; 12&#xD;
        IU/l.Patients with at least one embryo at transfer time&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Very high risk of OHSS (&gt; 30 follicles &gt; 12 mm the day of ovulation triggering). •&#xD;
             Reduced ovarian reserve&#xD;
&#xD;
               -  Fertilization failure&#xD;
&#xD;
               -  Severe endocrinopathy&#xD;
&#xD;
               -  Azoospermia&#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>Abdelhamid Benmachiche, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ibn roch infertility centre, cité boussouf, Constantine Algeria</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ibnrochd Clinic</name>
      <address>
        <city>Constantine</city>
        <zip>25000</zip>
        <country>Algeria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ibnrochd IVF center</name>
      <address>
        <city>Constantine</city>
        <zip>25000</zip>
        <country>Algeria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Algeria</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>July 5, 2017</last_update_submitted>
  <last_update_submitted_qc>July 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire Ibn Rochd</investigator_affiliation>
    <investigator_full_name>benmachiche abdelhamid</investigator_full_name>
    <investigator_title>Dr benmachiche abdelhamid, private infertility centre, Ibn rochd, constantine, Algeria</investigator_title>
  </responsible_party>
  <keyword>GnRH agonist trigger</keyword>
  <keyword>IVF</keyword>
  <keyword>Luteal phase support</keyword>
  <keyword>Mid-luteal GnRH agonist</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triptorelin Pamoate</mesh_term>
  </intervention_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/NCT03039049
org study id: 02053779
nct id: NCT03039049
lead sponsor: 
has dmc: Yes
Purpose:The aim of this project is to prospectively determine whether a single dose of
      GnRH-agonist administered at the time of implantation increases or not the reproductive
      outcome in patients undergoing in vitro fertilization ( IVF)/ intracytoplasmatic sperm
      injection(ICSI) triggered by a GnRH-agonist followed by a small bolus of human chorionic
      gonadotropin (hCG 1500 IU) the day of oocyte retrieval.
It has been reported in previous publications that the ovarian hyperstimulation syndrome
      (OHSS) was eliminated when GnRH agonist was used to trigger ovulation and the delivery rate
      has improved after modified luteal support especially when a small bolus of hCG is used on
      the day of oocyte retrieval. (OMEGA/HCG 1500 IU).

      However, a risk difference of 7% in delivery rates is still in favor of HCG trigger. Thus,
      further modifications in the luteal phase supplementation are required in order to optimise
      the reproductive outcome after GnRH-agonist triggering.

      Recently, many papers showed, that independently of the GnRH analogue used to prevent the
      premature LH surge, the addition of GnRH-agonist during the luteal phase seems to be
      beneficial in terms of pregnancy. Nevertheless, their use in practice is not yet admitted
      because of controversial results in terms of efficacy and safety particularly on the
      conceptus.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: implantation rate
time frame: Time Frame: 5 weeks after IVF/ICSI
description: number of gestational sacs per number of embryos transferred
measure: positive pregnancy test
time frame: Time Frame: 2 weeks after IVF/ICSI
description: confirmed by beta-hCG 14 days post embryo transfer
measure: Ongoing pregnancy
time frame: Time Frame: 12 weeks after IVF/ICSI
description: presence of foetal heart beat at 12 weeks of gestation
measure: Delivery rate
time frame: Time Frame: 26 weeks after IVF/ICSI
description: birth of baby beyond 26 weeks of gestation
measure: Early pregnancy loss
time frame: Time Frame: miscarriage before 5 weeks of gestation
description: loss of embryo before 5 weeks of gestation, chemical pregnancy and extra-uterine pregnancy
measure: ovarian hyperstimulation syndrome OHSS
time frame: Time Frame: from date of triggering until 2 weeks after pregnancy test]
description: early and late onset Ovarian hyper stimulation syndrome
arm group label: GnRH agonist
arm group type: Experimental
description: Drug: Triptorelin 0.1mg Triptorelin 0.1 mg administered subcutaneously 6 days after ovum pick-up (OPU) in IVF/ICSI cycles triggered by triptorelin 0.2 mg.
Other Names:
• Decapeptyl 0.1 mg
arm group label: Control
arm group type: No Intervention
description: No intervention
intervention type: Drug
intervention name: Triptorelin 0.1 mg
description: a single dose of Triptorelin 0.1 mg subcutaneously administered 6 days after oocyte retrieval.
arm group label: GnRH agonist
other name: Decapeptyl 0.1 mg
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Abdelhamid Benmachiche, M.D
role: Principal Investigator
affiliation: Ibn roch infertility centre, cité boussouf, Constantine Algeria
facility: 
facility: 
country: Algeria
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Universitaire Ibn Rochd
investigator full name: benmachiche abdelhamid
investigator title: Dr benmachiche abdelhamid, private infertility centre, Ibn rochd, constantine, Algeria
mesh term: Infertility
mesh term: Triptorelin Pamoate
sharing ipd: No