<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/NCT03836118</url>
  </required_header>
  <id_info>
    <org_study_id>7/18</org_study_id>
    <nct_id>NCT03836118</nct_id>
  </id_info>
  <brief_title>Intrauterine Insemination Predictor Factors</brief_title>
  <official_title>Retrospective Evaluation of Clinical Predictors of Pregnancy and Live-birth After Homologous Intrauterine Insemination</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>
      Multiple studies have reported on the impact of factors such as female age, duration of&#xD;
      infertility, type of infertility, hormone levels (i.e. AMH, FSH, estradiol, progesterone),&#xD;
      use of different ovarian stimulation protocols, timing/induction of ovulation, number of&#xD;
      pre-ovulatory follicles, endometrial thickness by the time of ovulation, sperm parameters&#xD;
      (i.e. concentration, progressive motility, morphology, total motile sperm count [TMSC],&#xD;
      inseminating motile count [IMC]) and sperm washing procedures. Also the influence of body&#xD;
      mass index and smoking on IUI outcome have been studied before. However, results on the&#xD;
      predictive value of these parameters remain highly contradictory. The aim of the study is to&#xD;
      examine the value of different variables in the prediction of IUI success to develop a&#xD;
      clinically useful predictive model of pregnancy and live birth.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 1997</start_date>
  <completion_date type="Actual">August 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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>clinical pregnancy rate (CPR)</measure>
    <time_frame>1997-2017</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>live-birth rate (LBR)</measure>
    <time_frame>1997 - 2017</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2970</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>IUI</arm_group_label>
    <description>all the IUI with controlled ovarian stimulation cycles in an academic tertiary ART center between January 1997 and December 2017</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Homologous intrauterine insemination (IUI)</intervention_name>
    <description>Patients were treated with HMG/rFSH according to classic protocols of therapy and monitoring. An injection of uHCG 5000 IU/ rHCG 250 mg was given to trigger ovulation. On the day of insemination, the semen sample was obtained through masturbation after a 2-5 day abstinence period and collected in a sterile cup. TMSC was determined by multiplying grade A or grade A + B sperm motility percentages by sperm volume and concentration. To evaluate sperm viability Eosin and Nigrosin (E&amp;N) staining was carried out according to WHO standards. Sperm capacitation was performed using density gradient centrifugation or swim-up procedure in order to remove seminal fluids and enhance sperm quality for IUI.&#xD;
IUI was performed a t36 hours post-HCG. A fraction of the washed motile spermatozoa was inserted up to the uterine fundus and expelled into the uterine cavity. Daily treatment with micronized progesterone was prescribed for 14 days after IUI. Serum ß-HCG was determined 14 days after IUI.</description>
    <arm_group_label>IUI</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The included couples were subjected to an infertility diagnostic work-up. The tests&#xD;
        included collecting medical history, physical examination, transvaginal ultrasound, serum&#xD;
        hormone assays between day 2 and 4 of the menstrual cycle, semen analysis, uterine cavity&#xD;
        and tubal patency evaluation with hysterosalpingography (HSG) or hysterosonosalpingography&#xD;
        (HSSG) and/or hysteroscopy and video laparoscopy. Assessment of vaginal infection with&#xD;
        cervico-vaginal swab and cultures&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  couples had been diagnosed with infertility according to WHO definition (failure to&#xD;
             achieve a clinical pregnancy after 12 months or more of regular unprotected sexual&#xD;
             intercourse)&#xD;
&#xD;
          -  at least one permeable tube&#xD;
&#xD;
          -  a motile sperm concentration post treatment of 1×106/mL on the day of the semen&#xD;
             analysis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Paolo Emanuele Levi Setti</name>
      <address>
        <city>Rozzano</city>
        <state>MI</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <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 11, 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 11, 2019</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>
  <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/NCT03836118
org study id: 7/18
nct id: NCT03836118
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Multiple studies have reported on the impact of factors such as female age, duration of
      infertility, type of infertility, hormone levels (i.e. AMH, FSH, estradiol, progesterone),
      use of different ovarian stimulation protocols, timing/induction of ovulation, number of
      pre-ovulatory follicles, endometrial thickness by the time of ovulation, sperm parameters
      (i.e. concentration, progressive motility, morphology, total motile sperm count [TMSC],
      inseminating motile count [IMC]) and sperm washing procedures. Also the influence of body
      mass index and smoking on IUI outcome have been studied before. However, results on the
      predictive value of these parameters remain highly contradictory. The aim of the study is to
      examine the value of different variables in the prediction of IUI success to develop a
      clinically useful predictive model of pregnancy and live birth.
observational model: Cohort
time perspective: Retrospective
measure: clinical pregnancy rate (CPR)
time frame: 1997-2017
measure: live-birth rate (LBR)
time frame: 1997 - 2017
arm group label: IUI
description: all the IUI with controlled ovarian stimulation cycles in an academic tertiary ART center between January 1997 and December 2017
intervention type: Procedure
intervention name: Homologous intrauterine insemination (IUI)
description: Patients were treated with HMG/rFSH according to classic protocols of therapy and monitoring. An injection of uHCG 5000 IU/ rHCG 250 mg was given to trigger ovulation. On the day of insemination, the semen sample was obtained through masturbation after a 2-5 day abstinence period and collected in a sterile cup. TMSC was determined by multiplying grade A or grade A + B sperm motility percentages by sperm volume and concentration. To evaluate sperm viability Eosin and Nigrosin (E&N) staining was carried out according to WHO standards. Sperm capacitation was performed using density gradient centrifugation or swim-up procedure in order to remove seminal fluids and enhance sperm quality for IUI.
IUI was performed a t36 hours post-HCG. A fraction of the washed motile spermatozoa was inserted up to the uterine fundus and expelled into the uterine cavity. Daily treatment with micronized progesterone was prescribed for 14 days after IUI. Serum ß-HCG was determined 14 days after IUI.
arm group label: IUI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Infertility
sharing ipd: No