<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/NCT03292770</url>
  </required_header>
  <id_info>
    <org_study_id>SMD-CAT-2017-01</org_study_id>
    <nct_id>NCT03292770</nct_id>
  </id_info>
  <brief_title>Mucus Removal Before Embryo Transfer</brief_title>
  <acronym>MUCRET</acronym>
  <official_title>EFFICACY STUDY OF THE UTILIZATION OF A FLUSHING CATHETER FOR REMOVAL OF CERVICAL MUCUS BEFORE AN EMBRYO TRANSFER: A RANDOMIZED PILOT 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite these revolutionary changes in the laboratory, little has changed with the process of&#xD;
      embryo transfer (ET). A study to prospectively evaluate the role of cervical mucus removal&#xD;
      prior to embryo transfer on pregnancy rates in ART will be undertaken.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ET involves placing the embryo(s) obtained before assisted reproduction technology (ART) into&#xD;
      the uterus via a catheter advanced through the cervical canal. Yet this is the final, and in&#xD;
      some respects the most critical, process in the sequential events that encompass an ART&#xD;
      cycle. If an embryo cannot be delivered to the uterine cavity atraumatically and in a&#xD;
      location for optimal implantation, the steps of ovarian hyperstimulation, oocyte retrieval,&#xD;
      embryo culture, and embryo selection will have no benefit. Contamination of the catheter with&#xD;
      blood may be a marker for difficult ET and has also been linked to poor ET outcomes. When&#xD;
      retrospectively assessing outcomes, Goudas et al. (1) demonstrated a clinical pregnancy rate&#xD;
      of 50% with no blood, and this rate fell by half when a small amount of blood was noted on&#xD;
      the catheter tip. Pregnancy rates fell even further, to 10%, when there was a significant&#xD;
      amount of blood (1). Similarly, in a preliminary study, blood or mucus on the tip was&#xD;
      associated with a significantly lower pregnancy outcome (2). Blood and mucus were associated&#xD;
      with an increased risk for unsuccessful transfers with odds ratios of 1.9 and 1.8,&#xD;
      respectively. Although all these data suggest a possible role of cervical mucus in embryo&#xD;
      transfer, there is no clinical evidence on the effect of removal of cervical mucus on the&#xD;
      outcome of IVF/ICSI. In view of this uncertainty, a study to prospectively evaluate the role&#xD;
      of cervical mucus removal prior to embryo transfer on pregnancy rates in ART will be&#xD;
      undertaken. It is hypothesized that removal of cervical mucus will achieve higher clinical&#xD;
      pregnancy rates.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 20, 2017</start_date>
  <completion_date type="Actual">May 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 30, 2018</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>
    <intervention_model_description>All participants will be randomized by an intention to treat approach. All other components of the IVF/ICSI cycle including stimulation medications, monitoring protocols, etc. will be at the discretion of the participant's primary physician; while this information will be documented it will not constitute criteria for enrolment. The group allocation will take place the day of the embryo transfer. The clinician will randomize all included patients into one of the two study groups using an open computer-generated list.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>All included patients will be blinded of the procedure.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Pregnancy Rate</measure>
    <time_frame>20 days after embryo transfer</time_frame>
    <description>Defined as the proportion of patients with a gestational sac seen 20 days after embryo transfer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biochemical Pregnancy Rate</measure>
    <time_frame>9 days after embryo transfer</time_frame>
    <description>Defined as the proportion of patients with ≥25 mIU/L of serum βhCG 9 days after embryo transfer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early Pregnancy Loss Rate</measure>
    <time_frame>20 days after embryo transfer</time_frame>
    <description>Defined as the proportion of patients with a pregnancy loss following a positive pregnancy test and/or a detectable gestational sac</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1118</enrollment>
  <condition>Infertility</condition>
  <condition>Embryo Transfer</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Embryo transfer will be performed as per clinic's routine protocol, where cervical mucus is gently removed with a cotton swab. No manipulation of the cervical canal is executed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Flushing Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A catheter will be used to perform a flushing of the cervical canal with culture media. The Flushing Catheter has a flared proximal end that is designed to affix to a standard Luer slip syringe and a pre-curved distal closed end, with a biseled opening on the side, 2mm from the tip, in which liquid flushes towards the outside of the cervical canal.&#xD;
Device: Cook Flushing Catheter J-IUIC-352200 (3.5fr 20cm flushing catheter with positioner closed end) (CEE approval).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Flushing Catheter</intervention_name>
    <description>A catheter will be used to performed a flushing of the cervical canal with culture media.</description>
    <arm_group_label>Flushing Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  IVF or OD patients with supernumerary embryos (oocyte's age will be considered as&#xD;
             patient's age).&#xD;
&#xD;
          -  Normal transvaginal ultrasound at screening, without evidence of clinically&#xD;
             significant abnormality consistent with finding adequate for ART with respect to&#xD;
             uterus and adnexa&#xD;
&#xD;
          -  Single embryo transfer&#xD;
&#xD;
          -  Embryo transfer at the blastocyst stage&#xD;
&#xD;
          -  Embryo with a morphological classification of ≥3BB&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preimplantation genetic diagnosis and/or screening&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>N/A</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jorge Rodriguez-Purata, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario Dexeus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario Dexeus</name>
      <address>
        <city>Barcelona</city>
        <zip>08022</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>May 30, 2018</last_update_submitted>
  <last_update_submitted_qc>May 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2018</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>Dr. Jorge Rodriguez-Purata</investigator_title>
  </responsible_party>
  <keyword>Embryo Transfer</keyword>
  <keyword>Flushing catheter</keyword>
  <keyword>Pregnancy rate</keyword>
  <keyword>Frozen Embryo Tranfer</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>
  </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/NCT03292770
org study id: SMD-CAT-2017-01
nct id: NCT03292770
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Despite these revolutionary changes in the laboratory, little has changed with the process of
      embryo transfer (ET). A study to prospectively evaluate the role of cervical mucus removal
      prior to embryo transfer on pregnancy rates in ART will be undertaken.
ET involves placing the embryo(s) obtained before assisted reproduction technology (ART) into
      the uterus via a catheter advanced through the cervical canal. Yet this is the final, and in
      some respects the most critical, process in the sequential events that encompass an ART
      cycle. If an embryo cannot be delivered to the uterine cavity atraumatically and in a
      location for optimal implantation, the steps of ovarian hyperstimulation, oocyte retrieval,
      embryo culture, and embryo selection will have no benefit. Contamination of the catheter with
      blood may be a marker for difficult ET and has also been linked to poor ET outcomes. When
      retrospectively assessing outcomes, Goudas et al. (1) demonstrated a clinical pregnancy rate
      of 50% with no blood, and this rate fell by half when a small amount of blood was noted on
      the catheter tip. Pregnancy rates fell even further, to 10%, when there was a significant
      amount of blood (1). Similarly, in a preliminary study, blood or mucus on the tip was
      associated with a significantly lower pregnancy outcome (2). Blood and mucus were associated
      with an increased risk for unsuccessful transfers with odds ratios of 1.9 and 1.8,
      respectively. Although all these data suggest a possible role of cervical mucus in embryo
      transfer, there is no clinical evidence on the effect of removal of cervical mucus on the
      outcome of IVF/ICSI. In view of this uncertainty, a study to prospectively evaluate the role
      of cervical mucus removal prior to embryo transfer on pregnancy rates in ART will be
      undertaken. It is hypothesized that removal of cervical mucus will achieve higher clinical
      pregnancy rates.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: All participants will be randomized by an intention to treat approach. All other components of the IVF/ICSI cycle including stimulation medications, monitoring protocols, etc. will be at the discretion of the participant's primary physician; while this information will be documented it will not constitute criteria for enrolment. The group allocation will take place the day of the embryo transfer. The clinician will randomize all included patients into one of the two study groups using an open computer-generated list.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: All included patients will be blinded of the procedure.
measure: Clinical Pregnancy Rate
time frame: 20 days after embryo transfer
description: Defined as the proportion of patients with a gestational sac seen 20 days after embryo transfer
measure: Biochemical Pregnancy Rate
time frame: 9 days after embryo transfer
description: Defined as the proportion of patients with ≥25 mIU/L of serum βhCG 9 days after embryo transfer
measure: Early Pregnancy Loss Rate
time frame: 20 days after embryo transfer
description: Defined as the proportion of patients with a pregnancy loss following a positive pregnancy test and/or a detectable gestational sac
arm group label: Control Group
arm group type: No Intervention
description: Embryo transfer will be performed as per clinic's routine protocol, where cervical mucus is gently removed with a cotton swab. No manipulation of the cervical canal is executed.
arm group label: Flushing Group
arm group type: Experimental
description: A catheter will be used to perform a flushing of the cervical canal with culture media. The Flushing Catheter has a flared proximal end that is designed to affix to a standard Luer slip syringe and a pre-curved distal closed end, with a biseled opening on the side, 2mm from the tip, in which liquid flushes towards the outside of the cervical canal.
Device: Cook Flushing Catheter J-IUIC-352200 (3.5fr 20cm flushing catheter with positioner closed end) (CEE approval).
intervention type: Device
intervention name: Flushing Catheter
description: A catheter will be used to performed a flushing of the cervical canal with culture media.
arm group label: Flushing Group
criteria: 
gender: Female
gender based: Yes
minimum age: N/A
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jorge Rodriguez-Purata, MD
role: Principal Investigator
affiliation: Hospital Universitario Dexeus
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Institut Universitari Dexeus
investigator full name: Jorge Rodriguez-Purata
investigator title: Dr. Jorge Rodriguez-Purata
mesh term: Infertility
sharing ipd: Undecided