<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/NCT04465045</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL20_0084</org_study_id>
    <nct_id>NCT04465045</nct_id>
  </id_info>
  <brief_title>Unexplained Infertility Treated by Hysteroscopy-laparoscopy</brief_title>
  <official_title>Unexplained Infertility Treated by Hysteroscopy-laparoscopy : Predictive Factors of Pregnancy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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>
      Retrospective study, including patients from january 2013 to december 2018, who were&#xD;
      diagnosed with unexplained infertility : spontaneously ovulating women with normal pelvic&#xD;
      ultrasound scan, patent tubes on hysterosalpingography and normal pelvic exam or pelvic MRI&#xD;
      normal. Semen analyses were normal according to the World Health Organization criteria.&#xD;
      Couples were referred for diagnostic laparoscopy and hysteroscopy. They were then addressed&#xD;
      for spontaneous fertility or ART to conceive. The investigators would like to see how many&#xD;
      surgeries were useful to assess a diagnostic, and if operating allows a satisfying pregnancy&#xD;
      rate. The investigators would like to assess how many diagnosis was done after surgery and&#xD;
      how many pregnancy were obtained. The investigators search other prognostic factors than age&#xD;
      or parity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">September 30, 2020</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</measure>
    <time_frame>1 day</time_frame>
    <description>pregnancy with an hearbeat on a pelvic ultrasound scan</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with miscarriage</measure>
    <time_frame>1 day</time_frame>
    <description>Number of Participants with miscarriage : positive pregnancy blood test, resulting in bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>live birth rate</measure>
    <time_frame>1 day</time_frame>
    <description>live birth rate : birth of a viable foetus after 24 SA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with fœtal losses</measure>
    <time_frame>1 day</time_frame>
    <description>Number of Participants with Foetal losses : loss of a non viable foetus, before 24 SA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with ectopic pregnancy</measure>
    <time_frame>1 day</time_frame>
    <description>Number of Participants with ectopic pregnancy: tubal pregnancy highly suspected by blood test or seen on a pelvic ultrasound scan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with surgical complications</measure>
    <time_frame>1 day</time_frame>
    <description>Number of Participants withSurgical complications : during surgery, and a few days after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with type of surgery</measure>
    <time_frame>1 day</time_frame>
    <description>Number of Participants with type of surgery: tubal surgeries, adhesiolysis, endometriosis surgeries, hysteroscopic gestures.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">250</enrollment>
  <condition>Unexplained Infertility</condition>
  <arm_group>
    <arm_group_label>Unique cohort</arm_group_label>
    <description>All women, 18 to 43 years, operated from laparoscopy-hysteroscopy for unexplained infertility in montpellier university hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopy-hysteroscopy</intervention_name>
    <description>Under general anesthesia, we start by a first look in laparoscopy, to look for endometriosis mainly, tubal infertility, ovarian cysts or any abnormalities that may not have been suspected on the first exam. Then we check tubal patency after a look at the uterine cavity by hysteroscopy. Then we treat everything possible to treat to improve fertility, spontaneous or with ART.</description>
    <arm_group_label>Unique cohort</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      some endometrial biopsy&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        In Montpellier University center only, France : from january 2013 to december 2018&#xD;
        unexplained infertile couple, trying to conceive for more than one year and operated by&#xD;
        laparoscopy-hysteroscopy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  18-43y&#xD;
&#xD;
          -  unexplained infertility&#xD;
&#xD;
          -  operated from laparoscopy-hysteroscopy at montpellier university hospital&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  an IMR that diagnoses formelly an endometriosis, or endometriosic ovarian cysts&#xD;
&#xD;
          -  any non respect to inclusion criterias&#xD;
&#xD;
          -  non respect of our definition of unexplained infertility (such as bilateral tubal&#xD;
             issue on hysterosalpingograms)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>43 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claire Vincens, doctor of medecine</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Uhmontpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>December 28, 2020</last_update_submitted>
  <last_update_submitted_qc>December 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ovulation</keyword>
  <keyword>semen analysis</keyword>
  <keyword>tubal patency</keyword>
  <keyword>pelvic ultrasound scan</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>NC</ipd_description>
  </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/NCT04465045
org study id: RECHMPL20_0084
nct id: NCT04465045
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Retrospective study, including patients from january 2013 to december 2018, who were
      diagnosed with unexplained infertility : spontaneously ovulating women with normal pelvic
      ultrasound scan, patent tubes on hysterosalpingography and normal pelvic exam or pelvic MRI
      normal. Semen analyses were normal according to the World Health Organization criteria.
      Couples were referred for diagnostic laparoscopy and hysteroscopy. They were then addressed
      for spontaneous fertility or ART to conceive. The investigators would like to see how many
      surgeries were useful to assess a diagnostic, and if operating allows a satisfying pregnancy
      rate. The investigators would like to assess how many diagnosis was done after surgery and
      how many pregnancy were obtained. The investigators search other prognostic factors than age
      or parity.
observational model: Cohort
time perspective: Retrospective
measure: clinical pregnancy rate
time frame: 1 day
description: pregnancy with an hearbeat on a pelvic ultrasound scan
measure: Number of Participants with miscarriage
time frame: 1 day
description: Number of Participants with miscarriage : positive pregnancy blood test, resulting in bleeding
measure: live birth rate
time frame: 1 day
description: live birth rate : birth of a viable foetus after 24 SA
measure: Number of Participants with fœtal losses
time frame: 1 day
description: Number of Participants with Foetal losses : loss of a non viable foetus, before 24 SA
measure: Number of Participants with ectopic pregnancy
time frame: 1 day
description: Number of Participants with ectopic pregnancy: tubal pregnancy highly suspected by blood test or seen on a pelvic ultrasound scan
measure: Number of Participants with surgical complications
time frame: 1 day
description: Number of Participants withSurgical complications : during surgery, and a few days after surgery
measure: Number of Participants with type of surgery
time frame: 1 day
description: Number of Participants with type of surgery: tubal surgeries, adhesiolysis, endometriosis surgeries, hysteroscopic gestures.
arm group label: Unique cohort
description: All women, 18 to 43 years, operated from laparoscopy-hysteroscopy for unexplained infertility in montpellier university hospital
intervention type: Procedure
intervention name: Laparoscopy-hysteroscopy
description: Under general anesthesia, we start by a first look in laparoscopy, to look for endometriosis mainly, tubal infertility, ovarian cysts or any abnormalities that may not have been suspected on the first exam. Then we check tubal patency after a look at the uterine cavity by hysteroscopy. Then we treat everything possible to treat to improve fertility, spontaneous or with ART.
arm group label: Unique cohort
some endometrial biopsy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 43 Years
healthy volunteers: No
last name: Claire Vincens, doctor of medecine
role: Study Director
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Infertility
sharing ipd: Undecided
ipd description: NC