<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/NCT03006523</url>
  </required_header>
  <id_info>
    <org_study_id>SMD-DEX-2016-03</org_study_id>
    <nct_id>NCT03006523</nct_id>
  </id_info>
  <brief_title>0.2 ml vs. 0.5 Inseminated Volume in Donor Intrauterine Insemination Cycles: A Prospective RCT</brief_title>
  <official_title>Impact of Inseminated Volume and Live Birth Rates After Intrauterine Insemination (IUI) With Donor Sperm (dIUI): A Prospective Randomized COntrolled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Universitari Dexeus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Universitari Dexeus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To prospectively determine the most appropriate inseminated volume in donor IUI cycles. It is&#xD;
      hypothesized that if the procedure is performed with 0.5 mL instead of 0.2, higher clinical&#xD;
      pregnancy rates will be achieved by promoting higher sperm densities in the fallopian tubes&#xD;
      at the time of ovulation by decreasing the amount of sperm cells lost during preparation and&#xD;
      handling.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective RCT will be performed, including patients undergoing dIUI under ovulation&#xD;
      induction. The trial is established to compare two inseminated volumes, 0.2 ml (control&#xD;
      group) and 0.5 mL (study group), and will be conducted at the Reproductive Medicine Service&#xD;
      of the Dexeus Women's Health Center. The Institutional Review Board has approved the research&#xD;
      project and an informed consent will be obtained from all patients participating to the&#xD;
      study.&#xD;
&#xD;
      All patients will undergo a full infertility investigation including hormonal evaluation&#xD;
      between day 2 and day 5 of the cycle and confirmation of patency of the Fallopian tubes.&#xD;
      Patients eligible for the study are between 18 and 40 years old, with regular menstrual&#xD;
      cycles (21 - 35 days). Indications for the use of donor sperm are male factor infertility due&#xD;
      to azoospermia or severe oligoasthenoteratozoospermia (requiring donor sperm), the presence&#xD;
      of a heritable genetic disorder in the male partner, a single-parent request or same-sex&#xD;
      couples' partners undergoing IUI. Exclusion criteria are the presence of tubal factor&#xD;
      infertility, ≥grade III endometriosis, more than 3 previous dIUI cycles, or patients in whom&#xD;
      ≥3 follicles &gt;14mm are observed during the cycle. The randomization procedure will take place&#xD;
      the day the donor IUI procedure. The randomization will be performed on the IUI cycle level.&#xD;
      Randomization into one of the two groups will be performed using an open computer-generated&#xD;
      list.&#xD;
&#xD;
      IUI will be performed with a Wallace® catheter depositing 0.2 or 0.5 ml of the sperm sample&#xD;
      at the uterine fundus. All IUIs will be performed between 12 p.m. and 4 pm. After the&#xD;
      procedure, 10 min of bed rest will be prescribed. Inseminations will be performed every day&#xD;
      of the week, including weekends.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Live birth rate</measure>
    <time_frame>Ten months after insemination procedure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Miscarriage rate</measure>
    <time_frame>Any pregnancy loss before week 20</time_frame>
    <description>Miscarriage was defined as a loss following a positive pregnancy test and/or detectable GS</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">293</enrollment>
  <condition>Infertility</condition>
  <condition>Infertility, Male</condition>
  <condition>Same-Sex Marriage</condition>
  <condition>Parent, Single</condition>
  <arm_group>
    <arm_group_label>Intrauterine Insemination with 200 µl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The sperm sample will be concentrated by centrifugation to a volume of 200 µl</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intrauterine Insemination with 500 µl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The sperm sample will be concentrated by centrifugation to a volume of 500 µl.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intrauterine insemination</intervention_name>
    <description>IUI will be performed with a Wallace® insemination 2 Catheter (Cooper Surgical, Trumbull, CT, USA) depositing 0.2 or 0.5 ml of the sperm sample at the uterine fundus. All IUIs will be performed between 12 p.m. and 4 p.m. After the procedure, 10 min of bed rest will be prescribed. Inseminations will be performed every day of the week, including weekends.</description>
    <arm_group_label>Intrauterine Insemination with 200 µl</arm_group_label>
    <arm_group_label>Intrauterine Insemination with 500 µl</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients will undergo a full infertility investigation including hormonal&#xD;
             evaluation between day 2 and day 5 of the cycle and confirmation of patency of the&#xD;
             Fallopian tubes.&#xD;
&#xD;
          -  Patients eligible for the study are between 18 and 40 years old and with regular&#xD;
             menstrual cycles (21 - 35 days). Indications for the use of donor sperm are severe&#xD;
             male factor infertility requiring donor sperm, the presence of a heritable genetic&#xD;
             disorder in the male partner, a single-parent request or same-sex couples' partners&#xD;
             undergoing IUI.&#xD;
&#xD;
          -  Exclusion criteria are the presence of tubal factor infertility, grade III-IV&#xD;
             endometriosis, more than 3 previous failed dIUI cycles, or patients in whom ≥3&#xD;
             follicles &gt;14mm are observed during the IUI cycle. Patients will be included in the&#xD;
             study only once. The randomization will be performed on the IUI cycle level. The group&#xD;
             allocation will take place the day the dIUI and the biologist will randomized all&#xD;
             included patients into one of the two groups using an open computer-generated list.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jorge Rodriguez-Purata, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Universitari Dexeus</affiliation>
  </overall_official>
  <reference>
    <citation>Veltman-Verhulst SM, Cohlen BJ, Hughes E, Heineman MJ. Intra-uterine insemination for unexplained subfertility. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD001838. doi: 10.1002/14651858.CD001838.pub4.</citation>
    <PMID>22972053</PMID>
  </reference>
  <reference>
    <citation>Cohlen BJ, Vandekerckhove P, te Velde ER, Habbema JD. Timed intercourse versus intra-uterine insemination with or without ovarian hyperstimulation for subfertility in men. Cochrane Database Syst Rev. 2000;(2):CD000360. doi: 10.1002/14651858.CD000360.</citation>
    <PMID>10796711</PMID>
  </reference>
  <reference>
    <citation>Goverde AJ, McDonnell J, Vermeiden JP, Schats R, Rutten FF, Schoemaker J. Intrauterine insemination or in-vitro fertilisation in idiopathic subfertility and male subfertility: a randomised trial and cost-effectiveness analysis. Lancet. 2000 Jan 1;355(9197):13-8. doi: 10.1016/S0140-6736(99)04002-7.</citation>
    <PMID>10615885</PMID>
  </reference>
  <reference>
    <citation>ESHRE Capri Workshop Group. Intrauterine insemination. Hum Reprod Update. 2009 May-Jun;15(3):265-77. doi: 10.1093/humupd/dmp003. Epub 2009 Feb 23.</citation>
    <PMID>19240042</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>January 2, 2017</last_update_submitted>
  <last_update_submitted_qc>January 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institut Universitari Dexeus</investigator_affiliation>
    <investigator_full_name>Jorge Rodriguez-Purata</investigator_full_name>
    <investigator_title>Attending Physician of IVF Center</investigator_title>
  </responsible_party>
  <keyword>donor intrauterine insemination</keyword>
  <keyword>insemination volume</keyword>
  <keyword>Live Birth Rates</keyword>
  <keyword>donor sperm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Male</mesh_term>
  </condition_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/NCT03006523
org study id: SMD-DEX-2016-03
nct id: NCT03006523
lead sponsor: 
has dmc: No
To prospectively determine the most appropriate inseminated volume in donor IUI cycles. It is
      hypothesized that if the procedure is performed with 0.5 mL instead of 0.2, higher clinical
      pregnancy rates will be achieved by promoting higher sperm densities in the fallopian tubes
      at the time of ovulation by decreasing the amount of sperm cells lost during preparation and
      handling.
A prospective RCT will be performed, including patients undergoing dIUI under ovulation
      induction. The trial is established to compare two inseminated volumes, 0.2 ml (control
      group) and 0.5 mL (study group), and will be conducted at the Reproductive Medicine Service
      of the Dexeus Women's Health Center. The Institutional Review Board has approved the research
      project and an informed consent will be obtained from all patients participating to the
      study.

      All patients will undergo a full infertility investigation including hormonal evaluation
      between day 2 and day 5 of the cycle and confirmation of patency of the Fallopian tubes.
      Patients eligible for the study are between 18 and 40 years old, with regular menstrual
      cycles (21 - 35 days). Indications for the use of donor sperm are male factor infertility due
      to azoospermia or severe oligoasthenoteratozoospermia (requiring donor sperm), the presence
      of a heritable genetic disorder in the male partner, a single-parent request or same-sex
      couples' partners undergoing IUI. Exclusion criteria are the presence of tubal factor
      infertility, ≥grade III endometriosis, more than 3 previous dIUI cycles, or patients in whom
      ≥3 follicles >14mm are observed during the cycle. The randomization procedure will take place
      the day the donor IUI procedure. The randomization will be performed on the IUI cycle level.
      Randomization into one of the two groups will be performed using an open computer-generated
      list.

      IUI will be performed with a Wallace® catheter depositing 0.2 or 0.5 ml of the sperm sample
      at the uterine fundus. All IUIs will be performed between 12 p.m. and 4 pm. After the
      procedure, 10 min of bed rest will be prescribed. Inseminations will be performed every day
      of the week, including weekends.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Live birth rate
time frame: Ten months after insemination procedure
measure: Miscarriage rate
time frame: Any pregnancy loss before week 20
description: Miscarriage was defined as a loss following a positive pregnancy test and/or detectable GS
arm group label: Intrauterine Insemination with 200 µl
arm group type: Active Comparator
description: The sperm sample will be concentrated by centrifugation to a volume of 200 µl
arm group label: Intrauterine Insemination with 500 µl
arm group type: Experimental
description: The sperm sample will be concentrated by centrifugation to a volume of 500 µl.
intervention type: Procedure
intervention name: Intrauterine insemination
description: IUI will be performed with a Wallace® insemination 2 Catheter (Cooper Surgical, Trumbull, CT, USA) depositing 0.2 or 0.5 ml of the sperm sample at the uterine fundus. All IUIs will be performed between 12 p.m. and 4 p.m. After the procedure, 10 min of bed rest will be prescribed. Inseminations will be performed every day of the week, including weekends.
arm group label: Intrauterine Insemination with 200 µl
arm group label: Intrauterine Insemination with 500 µl
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Jorge Rodriguez-Purata, MD
role: Principal Investigator
affiliation: Institut Universitari Dexeus
citation: Veltman-Verhulst SM, Cohlen BJ, Hughes E, Heineman MJ. Intra-uterine insemination for unexplained subfertility. Cochrane Database Syst Rev. 2012 Sep 12;(9):CD001838. doi: 10.1002/14651858.CD001838.pub4.
PMID: 22972053
citation: Cohlen BJ, Vandekerckhove P, te Velde ER, Habbema JD. Timed intercourse versus intra-uterine insemination with or without ovarian hyperstimulation for subfertility in men. Cochrane Database Syst Rev. 2000;(2):CD000360. doi: 10.1002/14651858.CD000360.
PMID: 10796711
citation: Goverde AJ, McDonnell J, Vermeiden JP, Schats R, Rutten FF, Schoemaker J. Intrauterine insemination or in-vitro fertilisation in idiopathic subfertility and male subfertility: a randomised trial and cost-effectiveness analysis. Lancet. 2000 Jan 1;355(9197):13-8. doi: 10.1016/S0140-6736(99)04002-7.
PMID: 10615885
citation: ESHRE Capri Workshop Group. Intrauterine insemination. Hum Reprod Update. 2009 May-Jun;15(3):265-77. doi: 10.1093/humupd/dmp003. Epub 2009 Feb 23.
PMID: 19240042
responsible party type: Principal Investigator
investigator affiliation: Institut Universitari Dexeus
investigator full name: Jorge Rodriguez-Purata
investigator title: Attending Physician of IVF Center
mesh term: Infertility
mesh term: Infertility, Male
sharing ipd: No