<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/NCT01703728</url>
  </required_header>
  <id_info>
    <org_study_id>000012</org_study_id>
    <nct_id>NCT01703728</nct_id>
  </id_info>
  <brief_title>Controlled Ovarian Stimulation by HP-hMG for IVF / ICSI Cycles: Study on Ovarian Hyper Stimulation Syndrome in a Cohort of Women From 18 to 36 Years Old.</brief_title>
  <acronym>SHOview</acronym>
  <official_title>SHOview Observational Study. Controlled Ovarian Stimulation by HP-hMG for IVF / ICSI Cycles: Study on Ovarian Hyper Stimulation Syndrome in a Cohort of Women From 18 to 36 Years Old.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ferring Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ferring Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ovarian hyper stimulation syndrome (OHSS) is a potentially serious complication of ovarian&#xD;
      stimulation in IVF (In Vitro Fertilisation). The main objective of this study is to describe&#xD;
      the incidence of moderate or severe forms of OHSS in women between 18 and 36 years of age&#xD;
      treated with HP-hMG.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of moderate/severe OHSS</measure>
    <time_frame>2-12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of each form of OHSS: mild, moderate and severe</measure>
    <time_frame>2-13 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of moderate and of severe OHSS among patients treated by a GnRH agonist or antagonist desensitization protocol</measure>
    <time_frame>2-13 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OHSS clinical features description according to the Royal College of Obstetricians and Gynaecologists classification</measure>
    <time_frame>2-13 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients' baseline characteristics</measure>
    <time_frame>At baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dosage adjustment, modification of the treatment, coasting and cycle cancellation, no hCG administration and embryo transfer cancellation</measure>
    <time_frame>Up to 3 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description and duration of hospitalisation, treatments prescribed</measure>
    <time_frame>2-13 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency and reasons for stimulation arrest and no embryo transfer decision</measure>
    <time_frame>2-4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of oocytes retrieved, number of mature oocytes, fertilization rate, embryo quality, embryo freezing, number and quality of transferred embryos</measure>
    <time_frame>2-3 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of serious and not serious adverse events</measure>
    <time_frame>2-13 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of patient's compliance to the prescribed treatment</measure>
    <time_frame>2-4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical pregnancy rate, spontaneous miscarriage and ongoing pregnancy rate</measure>
    <time_frame>4-13 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">455</enrollment>
  <condition>Ovarian Hyperstimulation Syndrome (OHSS)</condition>
  <arm_group>
    <arm_group_label>Highly purified menotropin (HP-hMG) treatment</arm_group_label>
    <description>Cohort of women from 18 to 36 years old treated by HP-hMG for controlled ovarian stimulation (COS) for a first or second cycle of IVF / ICSI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Highly purified menotropin (HP- hMG) treatment</intervention_name>
    <description>No intervention: patients treated by highly purified menotropin for COS according to physicians' current practice</description>
    <arm_group_label>Highly purified menotropin (HP-hMG) treatment</arm_group_label>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      No biological samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women from 18 to 36 years old treated by HP-hMG for controlled ovarian stimulation (COS)&#xD;
        for a first or second cycle of IVF / ICSI.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who present infertility of more than one year and are candidates for a first or&#xD;
             second IVF cycle with or without ICSI for whom HP-hMG is prescribed for COS.&#xD;
&#xD;
          -  Absence of infertility treatment during the last 3 months before enrolment.&#xD;
&#xD;
          -  Age: from 18 to 36 years old.&#xD;
&#xD;
          -  BMI between 18 and 30 kg / m².&#xD;
&#xD;
          -  Presence of both ovaries accessible to puncture and absence of ovarian or uterine&#xD;
             abnormalities.&#xD;
&#xD;
          -  Male or female infertility.&#xD;
&#xD;
          -  Ovarian stimulation by HP-hMG with pituitary desensitization by a GnRH agonist or&#xD;
             antagonist.&#xD;
&#xD;
          -  Normal ovarian reserve according to physician habitual evaluation.&#xD;
&#xD;
          -  Consent to participate of the no-interventional study and signature of the patients'&#xD;
             information sheet.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of a chronic disease, cancer or endocrine disease that could potentially&#xD;
             influence the results of the stimulation or that represents a contraindication for&#xD;
             ovarian stimulation.&#xD;
&#xD;
          -  Known endometriosis grade III or IV.&#xD;
&#xD;
          -  Contraindication to the use of gonadotropins or current pregnancy diagnosed by the&#xD;
             clinician.&#xD;
&#xD;
          -  Recurrent miscarriages, known genetic disease of one of the partners or indication of&#xD;
             a preimplantation genetic diagnosis (PGD).&#xD;
&#xD;
          -  Smoking over than 10 cigarettes / day.´&#xD;
&#xD;
          -  Participation in an interventional study at the time of inclusion.&#xD;
&#xD;
          -  Known poor ovarian response in a previous cycle of stimulation (number of oocyte&#xD;
             collected ≤ 3, and / or more than 2 previous IVF/ICSI cycles and / or abnormal result&#xD;
             in ovarian reserve test (AMH &lt; 1 ng/ml with Immunotech equipment or AMH&lt;0.7 ng/ml with&#xD;
             DSL equipment).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>36 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Development Support</last_name>
    <role>Study Director</role>
    <affiliation>Ferring Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cabinet Mirabeau Roy René (there may be other sites in this country)</name>
      <address>
        <city>Aix En Provence</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôtel Dieu</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique La Chataigneraie</name>
      <address>
        <city>Beaumont</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Pellegrin</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Léonard de Vinci</name>
      <address>
        <city>Chambray les tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI</name>
      <address>
        <city>Créteil</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Victor Jousselin</name>
      <address>
        <city>Dreux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Rhonalpin</name>
      <address>
        <city>Ecully</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet Médical Maréchal Leclerc</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Groupe Hospitalier du Havre - Hôpital Jacques Monod</name>
      <address>
        <city>Le Havre</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet Médical Lille avenue de Dunkerque</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Jeanne de Flandre</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Privé Natecia</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Marseille -Hôpital Conception</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Maternité de Metz</name>
      <address>
        <city>Metz</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabinet Médical de Prony</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital St Vincent de Paul</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Mutualiste La Sagesse</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Barriere P, Dewailly D, Duhamel A, Gayet V. [Ovarian hyperstimulation syndrome after stimulation with highly purified hMGfor in vitro fertilization: Observational study SHOview]. Gynecol Obstet Fertil Senol. 2017 May;45(5):283-290. doi: 10.1016/j.gofs.2017.03.004. Epub 2017 Apr 29. French.</citation>
    <PMID>28461237</PMID>
  </results_reference>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>May 29, 2017</last_update_submitted>
  <last_update_submitted_qc>May 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Hyperstimulation Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Menotropins</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/NCT01703728
org study id: 000012
nct id: NCT01703728
lead sponsor: 
has dmc: No
Ovarian hyper stimulation syndrome (OHSS) is a potentially serious complication of ovarian
      stimulation in IVF (In Vitro Fertilisation). The main objective of this study is to describe
      the incidence of moderate or severe forms of OHSS in women between 18 and 36 years of age
      treated with HP-hMG.
observational model: Cohort
time perspective: Prospective
measure: Incidence of moderate/severe OHSS
time frame: 2-12 weeks
measure: Incidence of each form of OHSS: mild, moderate and severe
time frame: 2-13 weeks
measure: Incidence of moderate and of severe OHSS among patients treated by a GnRH agonist or antagonist desensitization protocol
time frame: 2-13 weeks
measure: OHSS clinical features description according to the Royal College of Obstetricians and Gynaecologists classification
time frame: 2-13 weeks
measure: Patients' baseline characteristics
time frame: At baseline
measure: Dosage adjustment, modification of the treatment, coasting and cycle cancellation, no hCG administration and embryo transfer cancellation
time frame: Up to 3 weeks
measure: Description and duration of hospitalisation, treatments prescribed
time frame: 2-13 weeks
measure: Frequency and reasons for stimulation arrest and no embryo transfer decision
time frame: 2-4 weeks
measure: Number of oocytes retrieved, number of mature oocytes, fertilization rate, embryo quality, embryo freezing, number and quality of transferred embryos
time frame: 2-3 weeks
measure: Description of serious and not serious adverse events
time frame: 2-13 weeks
measure: Description of patient's compliance to the prescribed treatment
time frame: 2-4 weeks
measure: Clinical pregnancy rate, spontaneous miscarriage and ongoing pregnancy rate
time frame: 4-13 weeks
arm group label: Highly purified menotropin (HP-hMG) treatment
description: Cohort of women from 18 to 36 years old treated by HP-hMG for controlled ovarian stimulation (COS) for a first or second cycle of IVF / ICSI.
intervention type: Other
intervention name: Highly purified menotropin (HP- hMG) treatment
description: No intervention: patients treated by highly purified menotropin for COS according to physicians' current practice
arm group label: Highly purified menotropin (HP-hMG) treatment
No biological samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 36 Years
healthy volunteers: No
last name: Clinical Development Support
role: Study Director
affiliation: Ferring Pharmaceuticals
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country: France
citation: Barriere P, Dewailly D, Duhamel A, Gayet V. [Ovarian hyperstimulation syndrome after stimulation with highly purified hMGfor in vitro fertilization: Observational study SHOview]. Gynecol Obstet Fertil Senol. 2017 May;45(5):283-290. doi: 10.1016/j.gofs.2017.03.004. Epub 2017 Apr 29. French.
PMID: 28461237
responsible party type: Sponsor
mesh term: Ovarian Hyperstimulation Syndrome
mesh term: Syndrome
mesh term: Menotropins