<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/NCT03830723</url>
  </required_header>
  <id_info>
    <org_study_id>ovord</org_study_id>
    <nct_id>NCT03830723</nct_id>
  </id_info>
  <brief_title>Personalized Insemination Treatment Study</brief_title>
  <acronym>PITS</acronym>
  <official_title>Effect of Personalized Dosages of Rekovelle on the Number of Mature Follicles Reached in Intra-uterine Insemination</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinique Ovo</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinique Ovo</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>
      This study is intended for women undergoing their first cycle of 3 intrauterine&#xD;
      inseminations. All 3 inseminations will be personalized by using algorithms to determine the&#xD;
      dose of study medication.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study medication dosage for the first insemination cycle will be based on the woman's age as&#xD;
      well as her Anti-Mullerian Hormone (AMH) levels.&#xD;
&#xD;
      Study medication dosage for the second and third insemination will depend on ovarian response&#xD;
      (number of follicles) during previous insemination cycle and woman's age&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 9, 2020</start_date>
  <completion_date type="Actual">September 27, 2021</completion_date>
  <primary_completion_date type="Actual">January 20, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>open-label, prospective, dose-finding, single centre pilot study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ovarian response</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluate the dose-response Relationship of Rekovelle with respect to ovarian response in participants undergoing controlled ovarian stimulation for intrauterine insemination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pregnancy rate</measure>
    <time_frame>1 year</time_frame>
    <description>Evaluate pregnancy rate 6-8 weeks after insemination by ultrasound</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Infertility</condition>
  <condition>Intrauterine Insemination</condition>
  <condition>Reproduction</condition>
  <arm_group>
    <arm_group_label>Rekovelle (Follitropin delta)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All participants will receive a prescription for study medication Rekovelle (follitropin delta)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Follitropin delta</intervention_name>
    <description>Study medication doses during all 3 insemination will be personalized using a suggested algorithm</description>
    <arm_group_label>Rekovelle (Follitropin delta)</arm_group_label>
    <other_name>Rekovelle</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women having consented to the study&#xD;
&#xD;
          -  Women followed at fertility center&#xD;
&#xD;
          -  First IUI cycle&#xD;
&#xD;
          -  Women between the ages of 18 to 42 inclusively at time of consent form signature&#xD;
&#xD;
          -  AMH &lt; 35 pmol/L (4.9 ng/mL) in participants' file in the last 24 months&#xD;
&#xD;
          -  At least one permeable Fallopian tube confirmed by laparoscopy, hysterosalpingography&#xD;
             (HSG), hysterosalpingosonography (HSSG) or one pregnancy in the last 3 years&#xD;
&#xD;
          -  Insemination with either partner or donor sperm&#xD;
&#xD;
          -  Male partner semen analysis considered adequate for IUI in accordance to the centre's&#xD;
             standard practice&#xD;
&#xD;
          -  Menstrual cycles from 26 to 39 days&#xD;
&#xD;
          -  Presence of both ovaries&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to consent&#xD;
&#xD;
          -  Body weight &gt;100 kg&#xD;
&#xD;
          -  AMH ≥35 pmol/L (4.9 ng/mL) in participants' file in the last 24 months&#xD;
&#xD;
          -  Severe malformation (unicornuate or bicornuate uterus) or uterine anomaly including&#xD;
             fibroids ≥ 5 cm&#xD;
&#xD;
          -  Uncontrolled thyroid or adrenal dysfunction&#xD;
&#xD;
          -  Pituitary tumour&#xD;
&#xD;
          -  Persistent ovarian cysts or enlargement not due to PCOS (Polycystic ovary syndrome) &gt;&#xD;
             3 cm&#xD;
&#xD;
          -  Anovulatory women&#xD;
&#xD;
          -  Use of contraceptives in the last 3 months prior to start of stimulation&#xD;
&#xD;
          -  Diagnosis of hydrosalpinx&#xD;
&#xD;
          -  Malignancies&#xD;
&#xD;
          -  Breast pathology incompatible with gonadotropin stimulation&#xD;
&#xD;
          -  Hypersensitivity to follitropin delta or to any ingredient in the formulation&#xD;
&#xD;
          -  Addition of other infertility medication that can influence follicle stimulation and&#xD;
             maturation such as growth hormone (GH)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Fertile women undergoing intrauterine insemination</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacques Kadoch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinique Ovo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinique Ovo</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4P 2S4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>September 8, 2022</last_update_submitted>
  <last_update_submitted_qc>September 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2022</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>Infertility</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Follicle Stimulating Hormone</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/NCT03830723
org study id: ovord
nct id: NCT03830723
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is intended for women undergoing their first cycle of 3 intrauterine
      inseminations. All 3 inseminations will be personalized by using algorithms to determine the
      dose of study medication.
Study medication dosage for the first insemination cycle will be based on the woman's age as
      well as her Anti-Mullerian Hormone (AMH) levels.

      Study medication dosage for the second and third insemination will depend on ovarian response
      (number of follicles) during previous insemination cycle and woman's age
allocation: N/A
intervention model: Single Group Assignment
intervention model description: open-label, prospective, dose-finding, single centre pilot study.
primary purpose: Treatment
masking: None (Open Label)
measure: Ovarian response
time frame: 1 year
description: Evaluate the dose-response Relationship of Rekovelle with respect to ovarian response in participants undergoing controlled ovarian stimulation for intrauterine insemination
measure: Pregnancy rate
time frame: 1 year
description: Evaluate pregnancy rate 6-8 weeks after insemination by ultrasound
arm group label: Rekovelle (Follitropin delta)
arm group type: Other
description: All participants will receive a prescription for study medication Rekovelle (follitropin delta)
intervention type: Drug
intervention name: Follitropin delta
description: Study medication doses during all 3 insemination will be personalized using a suggested algorithm
arm group label: Rekovelle (Follitropin delta)
other name: Rekovelle
criteria: 
gender: Female
gender based: Yes
gender description: Fertile women undergoing intrauterine insemination
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jacques Kadoch, MD
role: Principal Investigator
affiliation: Clinique Ovo
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Infertility
mesh term: Follicle Stimulating Hormone
sharing ipd: No