<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/NCT03837223</url>
  </required_header>
  <id_info>
    <org_study_id>trigger</org_study_id>
    <nct_id>NCT03837223</nct_id>
  </id_info>
  <brief_title>RESCUE PROTOCOL AND FRESH EMBRYO TRANSFER</brief_title>
  <official_title>RESCUE PROTOCOL AND FRESH EMBRYO TRANSFER AFTER TRIGGER WITH ANALOGS OF GNRH: THE HUMANITAS PROTOCOL</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Clinico Humanitas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Clinico Humanitas</source>
  <oversight_info>
    <has_dmc>No</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>
      Ovarian Hyperstimulation Syndrome (OHSS) is one of the most dangerous complications of&#xD;
      Assisted Reproductive Technologies (ART) cycles. The use in clinical practice of the GnRH&#xD;
      antagonist has made it possible to perform the trigger with GnRH analogues reducing the risk&#xD;
      of OHSS. The trigger with analogue increases the Abortion Rate (AR) and reduces the Ongoing&#xD;
      Pregnancy Rate (OPR), because the luteal phase in these cycles is particularly deficient. To&#xD;
      reduce this occurrence several studies have focused on the importance of support of the&#xD;
      luteal phase. The aims of study is to evaluate OPR and AR in patients at intermediate risk of&#xD;
      OHSS (&lt;18 recovered oocytes) which performed GnRH trigger and rescue protocol.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2013</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>ongoing pregnancy rate (OPR)</measure>
    <time_frame>2013-2018</time_frame>
    <description>presence of gestational sac and fetal hearts beats showed on unltrasonography 7/8 weeks after embryo transfer</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">271</enrollment>
  <condition>GnRH Trigger and Rescue Protocol</condition>
  <arm_group>
    <arm_group_label>patients underwent &quot;rescue protocols&quot; and fresh embryotransfer</arm_group_label>
    <description>they were patients with good prognosis with a mean age of 34.13 ± 4.42 years, with a good ovarian reserve</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GnRH agonist</intervention_name>
    <description>In High Responder patients (HR) (more than 18 follicles with diameter ≥ 12mm at ovulation induction), the trigger was obtained with triptorelin 0.2 mg sc. In this cohort if less of 18 oocytes were retrieved, patients were considered at intermediate risk of OHSS and fresh transfer was performed. An adequate support of the luteal phase was initiated: HCG 1500 IU / sc the day of the pick up + estradiol 4 mg + vaginal progesterone 400 mg daily (Rescue protocol).</description>
    <arm_group_label>patients underwent &quot;rescue protocols&quot; and fresh embryotransfer</arm_group_label>
    <other_name>GnRH trigger</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        In HR patients (AMH&gt; 3.5 ng / ml, AFC&gt; 15 follicles and if more than 18 follicles with&#xD;
        diam. 12mm to induction) the trigger was obtained with triptorelin 0.2 mg / sc. In patients&#xD;
        considered to be at intermediate risk of OHSS a rescue protocol has been implemented (HCG&#xD;
        1500 IU / sc the day of the pick up + estradiol 4 mg + vaginal progesterone 400 mg daily)&#xD;
        and fresh embryo transfer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        AMH ( antimullerian hormone) &gt; 3.5 ng / ml, AFC (antral follicles count) &gt; 15 follicles and&#xD;
        if more than 18 follicles with diam. 12mm to induction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        high risk of OHSS ( ovarian hyperstimulation syndrome)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <results_reference>
    <citation>Kupka MS, Ferraretti AP, de Mouzon J, Erb K, D'Hooghe T, Castilla JA, Calhaz-Jorge C, De Geyter C, Goossens V; European IVF-Monitoring Consortium, for the European Society of Human Reproduction and Embryology. Assisted reproductive technology in Europe, 2010: results generated from European registers by ESHREdagger. Hum Reprod. 2014 Oct 10;29(10):2099-113. doi: 10.1093/humrep/deu175. Epub 2014 Jul 27.</citation>
    <PMID>25069504</PMID>
  </results_reference>
  <results_reference>
    <citation>Humaidan P, Kol S, Papanikolaou EG; Copenhagen GnRH Agonist Triggering Workshop Group. GnRH agonist for triggering of final oocyte maturation: time for a change of practice? Hum Reprod Update. 2011 Jul-Aug;17(4):510-24. doi: 10.1093/humupd/dmr008. Epub 2011 Mar 30.</citation>
    <PMID>21450755</PMID>
  </results_reference>
  <results_reference>
    <citation>Fatemi HM, Garcia-Velasco J. Avoiding ovarian hyperstimulation syndrome with the use of gonadotropin-releasing hormone agonist trigger. Fertil Steril. 2015 Apr;103(4):870-3. doi: 10.1016/j.fertnstert.2015.02.004. Epub 2015 Feb 24.</citation>
    <PMID>25724740</PMID>
  </results_reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 8, 2019</last_update_submitted>
  <last_update_submitted_qc>February 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03837223
org study id: trigger
nct id: NCT03837223
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Ovarian Hyperstimulation Syndrome (OHSS) is one of the most dangerous complications of
      Assisted Reproductive Technologies (ART) cycles. The use in clinical practice of the GnRH
      antagonist has made it possible to perform the trigger with GnRH analogues reducing the risk
      of OHSS. The trigger with analogue increases the Abortion Rate (AR) and reduces the Ongoing
      Pregnancy Rate (OPR), because the luteal phase in these cycles is particularly deficient. To
      reduce this occurrence several studies have focused on the importance of support of the
      luteal phase. The aims of study is to evaluate OPR and AR in patients at intermediate risk of
      OHSS (<18 recovered oocytes) which performed GnRH trigger and rescue protocol.
observational model: Cohort
time perspective: Retrospective
measure: ongoing pregnancy rate (OPR)
time frame: 2013-2018
description: presence of gestational sac and fetal hearts beats showed on unltrasonography 7/8 weeks after embryo transfer
arm group label: patients underwent "rescue protocols" and fresh embryotransfer
description: they were patients with good prognosis with a mean age of 34.13 ± 4.42 years, with a good ovarian reserve
intervention type: Drug
intervention name: GnRH agonist
description: In High Responder patients (HR) (more than 18 follicles with diameter ≥ 12mm at ovulation induction), the trigger was obtained with triptorelin 0.2 mg sc. In this cohort if less of 18 oocytes were retrieved, patients were considered at intermediate risk of OHSS and fresh transfer was performed. An adequate support of the luteal phase was initiated: HCG 1500 IU / sc the day of the pick up + estradiol 4 mg + vaginal progesterone 400 mg daily (Rescue protocol).
arm group label: patients underwent "rescue protocols" and fresh embryotransfer
other name: GnRH trigger
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 38 Years
healthy volunteers: No
citation: Kupka MS, Ferraretti AP, de Mouzon J, Erb K, D'Hooghe T, Castilla JA, Calhaz-Jorge C, De Geyter C, Goossens V; European IVF-Monitoring Consortium, for the European Society of Human Reproduction and Embryology. Assisted reproductive technology in Europe, 2010: results generated from European registers by ESHREdagger. Hum Reprod. 2014 Oct 10;29(10):2099-113. doi: 10.1093/humrep/deu175. Epub 2014 Jul 27.
PMID: 25069504
citation: Humaidan P, Kol S, Papanikolaou EG; Copenhagen GnRH Agonist Triggering Workshop Group. GnRH agonist for triggering of final oocyte maturation: time for a change of practice? Hum Reprod Update. 2011 Jul-Aug;17(4):510-24. doi: 10.1093/humupd/dmr008. Epub 2011 Mar 30.
PMID: 21450755
citation: Fatemi HM, Garcia-Velasco J. Avoiding ovarian hyperstimulation syndrome with the use of gonadotropin-releasing hormone agonist trigger. Fertil Steril. 2015 Apr;103(4):870-3. doi: 10.1016/j.fertnstert.2015.02.004. Epub 2015 Feb 24.
PMID: 25724740
responsible party type: Sponsor
sharing ipd: No