<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/NCT03307720</url>
  </required_header>
  <id_info>
    <org_study_id>AGONIST TRIGGER</org_study_id>
    <nct_id>NCT03307720</nct_id>
  </id_info>
  <brief_title>Agonist Versus Classical HCG Trigger (Poor Responders, Normoresponders and High Responders)</brief_title>
  <official_title>Agonist Trigger Versus Classical HCG Trigger in Controlled Ovarian Stimulation Among Three Different Subsets of Patients (Poor Responders, Normoresponders and High Responders)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ginegorama S.L.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ginegorama S.L.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Agonist triggering in controlled ovarian stimulation protocols is being used during last&#xD;
      years (among high responder patients to avoid OHSS).&#xD;
&#xD;
      Indeed, agonist triggering is more physiologic than HCG triggering. Investigators propose to&#xD;
      compare the effectiveness of both types of trigger among three different subsets of patients:&#xD;
&#xD;
        1. Poor responders.&#xD;
&#xD;
        2. Normo-responders&#xD;
&#xD;
        3. High responders Comparing both the number and the quality of achieved oocytes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the last years, ovulation triggering in controlled ovarian stimulation protocols has&#xD;
      been used specially to avoid hyperstimulation syndromes (OHSS). Indeed, the substitution of&#xD;
      the classical HCG triggering by the agonist one, reduces almost to zero the risk of OHSS.&#xD;
&#xD;
      On the other hand poor responder patients to ovarian stimulation represent a challenge in&#xD;
      assisted reproduction. Defining poor responders is not easy, but we can define them as those&#xD;
      patients with less than 4 eggs obtained after oocyte retrieval.&#xD;
&#xD;
      Different strategies have been proposed to overcome this problem. In other words, to obtain&#xD;
      more oocytes. These include an increase in FSH doses, an increase in FSH action by adding&#xD;
      sensitizers agents.&#xD;
&#xD;
      Among the possible strategies, investigators propose the agonist triggering. HCG (classical)&#xD;
      triggering represents the use of a LH-like product (with a prolonged action). The&#xD;
      administration of a GnRH agonist provoke the production and liberation of both FSH and LH.&#xD;
      Thus, the pro-ovulatory action is more physiologic , and possibly, more effective.&#xD;
&#xD;
      So, the use of a triggering protocol that nowadays is being used among high responders (thus&#xD;
      reducing the OHSS risk) is proposed for both poor responder and normo-responder patients&#xD;
      trying to achieve more oocytes, and specifically more mature oocytes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 18, 2017</start_date>
  <completion_date type="Anticipated">May 2018</completion_date>
  <primary_completion_date type="Anticipated">February 2018</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>IVF patients enrolled either to HCG or agonist trigger ovulation induction</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mature oocytes</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Number of mature oocytes achieved after oocyte retrieval.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relation mature oocytes/punctured oocytes</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Relation between the number of mature oocytes and the follicles.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fertilized oocytes</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Number of fertilized oocytes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation fertilized oocytes/achieved Mature oocytes</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Relation between the number of fertilized oocytes and the mature oocytes achieved.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of blastocysts developed</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Number of blastocysts developed in each arm of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancelled cycles</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>Percentage of cancelled cycles</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Ovulation Induction</condition>
  <condition>In Vitro Fertilization (IVF)</condition>
  <condition>Infertility, Female</condition>
  <condition>Oocytes</condition>
  <arm_group>
    <arm_group_label>Poor responders. Classical trigger</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval.&#xD;
Women scheduled for IVF treatment with 4 or less antral follicles in ultrasound assessment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Poor responders. Agonist trigger</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval)&#xD;
Women scheduled for IVF treatment with 4 or less antral follicles in ultrasound assessment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normo responders. Classical trigger</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval.&#xD;
Women scheduled for IVF treatment with more than 4 and less than 16 antral follicles in ultrasound assessment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normo responders. Agonist trigger</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval)&#xD;
Women scheduled for IVF treatment with more than 4 and less than 16 antral follicles in ultrasound assessment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High responders. Classical trigger</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval.&#xD;
Women scheduled for IVF treatment with more than 15 antral follicles in ultrasound assessment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High responders. Agonist trigger</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval)&#xD;
Women scheduled for IVF treatment with more than 15 antral follicles in ultrasound assessment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gonadotropin Releasing Hormone Agonists (GNRH-A)</intervention_name>
    <description>Administration of a gonadotropin releasing hormone agonist (GnRH-a) (0,2 ml) subcutaneously, 36 hours before ovum pick-up in IVF treatments.</description>
    <arm_group_label>High responders. Agonist trigger</arm_group_label>
    <arm_group_label>Normo responders. Agonist trigger</arm_group_label>
    <arm_group_label>Poor responders. Agonist trigger</arm_group_label>
    <other_name>Agonist trigger</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Human chorionic gonadotropin</intervention_name>
    <description>Administration of Human chorionic gonadotropin (HCG) 250 IU subcutaneously , 36 hours before ovum pick-up in IVF treatments.</description>
    <arm_group_label>High responders. Classical trigger</arm_group_label>
    <arm_group_label>Normo responders. Classical trigger</arm_group_label>
    <arm_group_label>Poor responders. Classical trigger</arm_group_label>
    <other_name>HCG trigger</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women scheduled for IVF treatment.&#xD;
&#xD;
          -  First ovarian stimulation&#xD;
&#xD;
          -  Two ovaries present&#xD;
&#xD;
          -  No previous ovarian surgery&#xD;
&#xD;
          -  No contraindication for any of the assigned treatments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous ovarian surgery.&#xD;
&#xD;
          -  Previous IVF treatments.&#xD;
&#xD;
          -  Absence of one ovary&#xD;
&#xD;
          -  Presence of an endometrioma&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>48 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gorka Barrenetxea, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko Unibertsitatea</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jon Iker Arambarri, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko Unibertsitatea</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gorka Barrenetxea, PhD</last_name>
    <phone>00 34 605711484</phone>
    <email>gbarrenetxea@reproduccionbilbao.es</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amaia Garcia, PhD</last_name>
    <email>agarcia@reproduccionbilbao.es</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Reproduccion Bilbao Assisted Reproduction Center</name>
      <address>
        <city>Bilbao</city>
        <state>Bizkaia</state>
        <zip>48014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 30, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>December 8, 2017</last_update_submitted>
  <last_update_submitted_qc>December 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ginegorama S.L.</investigator_affiliation>
    <investigator_full_name>Gorka Barrenetxea</investigator_full_name>
    <investigator_title>Professor of Gynecology &amp; Obstetrics Universidad del País Vasco/Euskal Herriko Unibertsitatea. Medical Director of Reproducción Bilbao</investigator_title>
  </responsible_party>
  <keyword>agonist trigger</keyword>
  <keyword>Ovulation induction</keyword>
  <keyword>Controlled ovarian stimulation (COS)</keyword>
  <keyword>Poor responder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chorionic Gonadotropin</mesh_term>
    <mesh_term>Hormones</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/NCT03307720
org study id: AGONIST TRIGGER
nct id: NCT03307720
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Agonist triggering in controlled ovarian stimulation protocols is being used during last
      years (among high responder patients to avoid OHSS).

      Indeed, agonist triggering is more physiologic than HCG triggering. Investigators propose to
      compare the effectiveness of both types of trigger among three different subsets of patients:

        1. Poor responders.

        2. Normo-responders

        3. High responders Comparing both the number and the quality of achieved oocytes.
During the last years, ovulation triggering in controlled ovarian stimulation protocols has
      been used specially to avoid hyperstimulation syndromes (OHSS). Indeed, the substitution of
      the classical HCG triggering by the agonist one, reduces almost to zero the risk of OHSS.

      On the other hand poor responder patients to ovarian stimulation represent a challenge in
      assisted reproduction. Defining poor responders is not easy, but we can define them as those
      patients with less than 4 eggs obtained after oocyte retrieval.

      Different strategies have been proposed to overcome this problem. In other words, to obtain
      more oocytes. These include an increase in FSH doses, an increase in FSH action by adding
      sensitizers agents.

      Among the possible strategies, investigators propose the agonist triggering. HCG (classical)
      triggering represents the use of a LH-like product (with a prolonged action). The
      administration of a GnRH agonist provoke the production and liberation of both FSH and LH.
      Thus, the pro-ovulatory action is more physiologic , and possibly, more effective.

      So, the use of a triggering protocol that nowadays is being used among high responders (thus
      reducing the OHSS risk) is proposed for both poor responder and normo-responder patients
      trying to achieve more oocytes, and specifically more mature oocytes.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: IVF patients enrolled either to HCG or agonist trigger ovulation induction
primary purpose: Treatment
masking: None (Open Label)
measure: Mature oocytes
time frame: Up to 24 weeks
description: Number of mature oocytes achieved after oocyte retrieval.
measure: Relation mature oocytes/punctured oocytes
time frame: Up to 24 weeks
description: Relation between the number of mature oocytes and the follicles.
measure: Fertilized oocytes
time frame: Up to 24 weeks
description: Number of fertilized oocytes
measure: Relation fertilized oocytes/achieved Mature oocytes
time frame: Up to 24 weeks
description: Relation between the number of fertilized oocytes and the mature oocytes achieved.
measure: Number of blastocysts developed
time frame: Up to 24 weeks
description: Number of blastocysts developed in each arm of the study.
measure: Cancelled cycles
time frame: Up to 24 weeks
description: Percentage of cancelled cycles
arm group label: Poor responders. Classical trigger
arm group type: Active Comparator
description: Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval.
Women scheduled for IVF treatment with 4 or less antral follicles in ultrasound assessment.
arm group label: Poor responders. Agonist trigger
arm group type: Experimental
description: Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval)
Women scheduled for IVF treatment with 4 or less antral follicles in ultrasound assessment.
arm group label: Normo responders. Classical trigger
arm group type: Active Comparator
description: Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval.
Women scheduled for IVF treatment with more than 4 and less than 16 antral follicles in ultrasound assessment.
arm group label: Normo responders. Agonist trigger
arm group type: Experimental
description: Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval)
Women scheduled for IVF treatment with more than 4 and less than 16 antral follicles in ultrasound assessment.
arm group label: High responders. Classical trigger
arm group type: Active Comparator
description: Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval.
Women scheduled for IVF treatment with more than 15 antral follicles in ultrasound assessment.
arm group label: High responders. Agonist trigger
arm group type: Experimental
description: Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval)
Women scheduled for IVF treatment with more than 15 antral follicles in ultrasound assessment.
intervention type: Drug
intervention name: Gonadotropin Releasing Hormone Agonists (GNRH-A)
description: Administration of a gonadotropin releasing hormone agonist (GnRH-a) (0,2 ml) subcutaneously, 36 hours before ovum pick-up in IVF treatments.
arm group label: High responders. Agonist trigger
arm group label: Normo responders. Agonist trigger
arm group label: Poor responders. Agonist trigger
other name: Agonist trigger
intervention type: Drug
intervention name: Human chorionic gonadotropin
description: Administration of Human chorionic gonadotropin (HCG) 250 IU subcutaneously , 36 hours before ovum pick-up in IVF treatments.
arm group label: High responders. Classical trigger
arm group label: Normo responders. Classical trigger
arm group label: Poor responders. Classical trigger
other name: HCG trigger
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 48 Years
healthy volunteers: No
last name: Gorka Barrenetxea, PhD
role: Principal Investigator
affiliation: Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko Unibertsitatea
last name: Jon Iker Arambarri, MD
role: Study Chair
affiliation: Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko Unibertsitatea
last name: Gorka Barrenetxea, PhD
phone: 00 34 605711484
email: gbarrenetxea@reproduccionbilbao.es
last name: Amaia Garcia, PhD
email: agarcia@reproduccionbilbao.es
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Ginegorama S.L.
investigator full name: Gorka Barrenetxea
investigator title: Professor of Gynecology & Obstetrics Universidad del País Vasco/Euskal Herriko Unibertsitatea. Medical Director of Reproducción Bilbao
mesh term: Infertility
mesh term: Infertility, Female
mesh term: Chorionic Gonadotropin
mesh term: Hormones
sharing ipd: No