<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/NCT02200952</url>
  </required_header>
  <id_info>
    <org_study_id>Luveris75UI</org_study_id>
    <nct_id>NCT02200952</nct_id>
  </id_info>
  <brief_title>Luteal Phase Supplementation With Recombinant LH After GnRh Agonist Oocytes Triggering in Women at Risk of OHSS</brief_title>
  <official_title>Luteal Phase Supplementation With Recombinant LH After GnRh Agonist Oocytes Triggering in Women at Risk of OHSS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Carlo Public Hospital, Potenza, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>San Carlo Public Hospital, Potenza, Italy</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to prove that luteal phase supplementation with recombinant LH&#xD;
      can solve the luteal phase deficiency after Gnrh agonist oocytes triggering in women at risk&#xD;
      of OHSS&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators enrolled patients, undergoing controlled ovarian stimulation for an&#xD;
      IVF/ICSI cycles, who on the day of oocytes triggering were at risk of OHSS.&#xD;
&#xD;
      These patients had an estradiol &gt; 4000 pg/ml and more than 24 follicles with a diameter&#xD;
      greater than 12 mm.&#xD;
&#xD;
      The investigators used 0,2 mg of triptorelin for the oocytes triggering and supplemented the&#xD;
      luteal phase with recombinant LH at a dose of 75 UI twice/day for 10 days and vaginal gel&#xD;
      progesterone and oral oestradiol for 14 days The investigators measured bhCG at 14 days from&#xD;
      the pick up. In case of positive bhCG we have defined the IVF/ICSI outcome: Pregnancy Rate&#xD;
      and Implantation Rate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2013</start_date>
  <completion_date type="Actual">June 30, 2014</completion_date>
  <primary_completion_date type="Actual">June 30, 2014</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>9 Months</target_duration>
  <primary_outcome>
    <measure>Pregnancy Rate and Implantation Rate</measure>
    <time_frame>From 14 days after the pick up to six weeks of gestation</time_frame>
    <description>We measured bhCG after 14 days from the pick up. In presence of a positive value of bhCG we evaluated IVF/ICSI outcome through the pregnancy rate and implantation rate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ealy and Late Ovarian Hyperstimulation Syndrome</measure>
    <time_frame>From 9 days after pick up to 12 weeks of gestation</time_frame>
    <description>We evaluated early and late ovarian hyperstimulation syndrome according the practice committee of ASRM 2008 and Current Clinical Guideline for OHSS of 2010</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Ovarian Hyperstimulation Syndrome</condition>
  <arm_group>
    <arm_group_label>Patients at risk of OHSS</arm_group_label>
    <description>Patients at risk of OHSS on the oocytes triggering day with an oestradiol &gt; 4000pg/ml or a number of follicles greater than 24 of a diameter greater than 12 mm</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>recombinant LH</intervention_name>
    <description>recombinant LH twice/day for 10 days from pick up</description>
    <arm_group_label>Patients at risk of OHSS</arm_group_label>
    <other_name>Luveris rLH by Merck Serono</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Infertile patients undergoing controlled ovarian hyperstimulation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with an oestradiol &gt; 4000 pg/ml on the oocytes triggering day&#xD;
&#xD;
          -  patient with more than 24 follicles of diameter greater than 12 mm on the oocytes&#xD;
             triggering day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with no risk of OHSS on the oocytes triggering day&#xD;
&#xD;
          -  patients with an oestradiol &lt; 4000 pg/ml on the oocytes triggering day&#xD;
&#xD;
          -  patient with less than 24 follicles of diameter greater than 12 mm on the oocytes&#xD;
             triggering day&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>43 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Assunta Iuliano, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Carlo Public Hospital, Potenza, Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Carlo Public Hospital</name>
      <address>
        <city>Potenza</city>
        <state>Basilicata</state>
        <zip>85100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San carlo Public Hospital</name>
      <address>
        <city>Potenza</city>
        <state>Basilica</state>
        <zip>85100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Papanikolaou EG, Verpoest W, Fatemi H, Tarlatzis B, Devroey P, Tournaye H. A novel method of luteal supplementation with recombinant luteinizing hormone when a gonadotropin-releasing hormone agonist is used instead of human chorionic gonadotropin for ovulation triggering: a randomized prospective proof of concept study. Fertil Steril. 2011 Mar 1;95(3):1174-7. doi: 10.1016/j.fertnstert.2010.09.023. Epub 2010 Oct 27.</citation>
    <PMID>20979997</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>November 22, 2020</last_update_submitted>
  <last_update_submitted_qc>November 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Carlo Public Hospital, Potenza, Italy</investigator_affiliation>
    <investigator_full_name>Assunta Iuliano, MD</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>OHSS</keyword>
  <keyword>Oocytes triggering</keyword>
  <keyword>GnRh agonist triggering</keyword>
  <keyword>Luteal phase supplementation</keyword>
  <keyword>recombinant LH</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Hyperstimulation Syndrome</mesh_term>
  </condition_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/NCT02200952
org study id: Luveris75UI
nct id: NCT02200952
lead sponsor: 
has dmc: No
The purpose of this study is to prove that luteal phase supplementation with recombinant LH
      can solve the luteal phase deficiency after Gnrh agonist oocytes triggering in women at risk
      of OHSS
The investigators enrolled patients, undergoing controlled ovarian stimulation for an
      IVF/ICSI cycles, who on the day of oocytes triggering were at risk of OHSS.

      These patients had an estradiol > 4000 pg/ml and more than 24 follicles with a diameter
      greater than 12 mm.

      The investigators used 0,2 mg of triptorelin for the oocytes triggering and supplemented the
      luteal phase with recombinant LH at a dose of 75 UI twice/day for 10 days and vaginal gel
      progesterone and oral oestradiol for 14 days The investigators measured bhCG at 14 days from
      the pick up. In case of positive bhCG we have defined the IVF/ICSI outcome: Pregnancy Rate
      and Implantation Rate.
observational model: Other
time perspective: Prospective
measure: Pregnancy Rate and Implantation Rate
time frame: From 14 days after the pick up to six weeks of gestation
description: We measured bhCG after 14 days from the pick up. In presence of a positive value of bhCG we evaluated IVF/ICSI outcome through the pregnancy rate and implantation rate.
measure: Ealy and Late Ovarian Hyperstimulation Syndrome
time frame: From 9 days after pick up to 12 weeks of gestation
description: We evaluated early and late ovarian hyperstimulation syndrome according the practice committee of ASRM 2008 and Current Clinical Guideline for OHSS of 2010
arm group label: Patients at risk of OHSS
description: Patients at risk of OHSS on the oocytes triggering day with an oestradiol > 4000pg/ml or a number of follicles greater than 24 of a diameter greater than 12 mm
intervention type: Drug
intervention name: recombinant LH
description: recombinant LH twice/day for 10 days from pick up
arm group label: Patients at risk of OHSS
other name: Luveris rLH by Merck Serono
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 43 Years
healthy volunteers: No
last name: Assunta Iuliano, MD, PhD
role: Principal Investigator
affiliation: San Carlo Public Hospital, Potenza, Italy
facility: 
facility: 
country: Italy
citation: Papanikolaou EG, Verpoest W, Fatemi H, Tarlatzis B, Devroey P, Tournaye H. A novel method of luteal supplementation with recombinant luteinizing hormone when a gonadotropin-releasing hormone agonist is used instead of human chorionic gonadotropin for ovulation triggering: a randomized prospective proof of concept study. Fertil Steril. 2011 Mar 1;95(3):1174-7. doi: 10.1016/j.fertnstert.2010.09.023. Epub 2010 Oct 27.
PMID: 20979997
responsible party type: Principal Investigator
investigator affiliation: San Carlo Public Hospital, Potenza, Italy
investigator full name: Assunta Iuliano, MD
investigator title: MD, PhD
mesh term: Ovarian Hyperstimulation Syndrome