<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/NCT02197832</url>
  </required_header>
  <id_info>
    <org_study_id>HKU-VL-FETEA</org_study_id>
    <nct_id>NCT02197832</nct_id>
  </id_info>
  <brief_title>A RCT on the Effect of Endometrial Injury on Improving Ongoing Pregnancy Rate in Subfertile Women Undergoing FET Cycles</brief_title>
  <official_title>A Randomized Controlled Trial on the Effect of Endometrial Injury on Improving Ongoing Pregnancy Rate in Subfertile Women Undergoing Frozen-thawed Embryo Transfer Treatment Cycles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomised controlled trial on the effect of endometrial injury in the cycle&#xD;
      preceding the frozen-thawed embryo transfer (FET) cycles. The study hypothesis is that&#xD;
      endometrial injury will increase the ongoing pregnancy rate in FET cycles.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Consecutive women attending subfertility clinic at Queen Mary Hospital, University of Hong&#xD;
      Kong who are scheduled for FET treatment will be recruited. Women who have normal uterine&#xD;
      cavity will be randomized into study and control groups in 1 to 1 ratio according to a&#xD;
      computer-generated randomization list.&#xD;
&#xD;
      For patients in the study group, in the cycle immediately preceding the scheduled FET&#xD;
      treatment, an endometrial biopsy would be arranged on day 21-23 of the menstrual cycles and&#xD;
      they will be instructed to use non-hormonal means of contraception during that cycle. For&#xD;
      patient in the control group, a similar procedure would be performed on the same timing&#xD;
      during the preceding cycles without entering the uterine cavity, ie endometrial biopsy&#xD;
      catheter entering the endocervical canal without entering the endometrial cavity. All&#xD;
      patients will then proceed to FET treatment in the next cycle as scheduled.&#xD;
&#xD;
      The FET would be carried out as per our protocol. In short, patients attend the clinic daily&#xD;
      from 18 days before the next expected period for the determination of serum E2 and&#xD;
      luteinising hormone (LH) concentrations until the LH surge, which was defined as the day on&#xD;
      which the LH level was above 20 IU/L and doubled the average of the LH levels over the past&#xD;
      three days. For patients with irregular menstrual cycles or no ovulation demonstrated during&#xD;
      natural cycle monitoring, clomiphene citrate (CC, Clomid, Merrell, Staines, U.K.) 50-100 mg&#xD;
      will be given daily for five days from Days 3-7. The cycle will be monitored by blood tests&#xD;
      from day 10 of the cycle as above. FET was performed on the third day after the LH surge. Up&#xD;
      to two frozen-thawed embryo(s) can be transferred. No luteal phase support is used. On-going&#xD;
      pregnancy rates, defined as viable fetuses beyond 10-12 gestational weeks, between the two&#xD;
      groups will be compared.&#xD;
&#xD;
      We should measure endometrial thickness on LH+1 in natural and clomid-induced cycles.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficulty in recruiting participants.&#xD;
  </why_stopped>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ongoing pregnancy rate</measure>
    <time_frame>pregnancy at 10-12 weeks</time_frame>
    <description>Pregnancy at 10-12 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implantation rate</measure>
    <time_frame>4-6 weeks after embryo transfer</time_frame>
    <description>Implantation rate = number of gestation sacs on ultrasound (USG) / number of embryos transferred</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>6 weeks after embryo transfer</time_frame>
    <description>Clinical pregnancy rate is the presence of gestation sac on USG scan.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Subfertility</condition>
  <arm_group>
    <arm_group_label>EA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>in the cycle immediately preceding the scheduled FET treatment, an endometrial biopsy would be arranged on day 21-23 of the menstrual cycles and they will be instructed to use non-hormonal means of contraception during that cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The procedure was performed in a standard approach using a Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France). The pipelle catheter was introduced through the cervix but not into the uterine cavity, only entering the endocervical canal as control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endometrial biopsy</intervention_name>
    <description>The procedure was performed in a standard approach using a Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France). The pipelle catheter was introduced through the cervix up to the uterine fundus. The piston was drawn back to the end of the sheath to create a negative pressure. The sheath was rotated and moved back and forth between the fundus and internal os for at least 3-4 times before it was gently withdrawn.</description>
    <arm_group_label>EA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>control procedure</intervention_name>
    <description>Using pipelle catheter without entering the uterine cavity.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France)</intervention_name>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing FET treatment cycles&#xD;
&#xD;
          -  Normal uterine cavity as shown on transvaginal scanning or saline sonogram done at&#xD;
             baseline&#xD;
&#xD;
          -  endometrial thickness &gt;=8mm during the stimulated IVF cycle and FET cycle&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy in previous IVF or FET cycles&#xD;
&#xD;
          -  Presence of hydrosalpinx not surgically corrected prior to FET&#xD;
&#xD;
          -  Presence of endometrial polyp or fibroid distorting uterine cavity&#xD;
&#xD;
          -  IVF cycles carried out for preimplantation genetic diagnosis&#xD;
&#xD;
          -  Arrange for blastocyst transfer&#xD;
&#xD;
          -  Use of donor oocytes&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vivian CY Lee, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen Mary Hospital / University of Hong Kong.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Queen Mary Hospital</name>
      <address>
        <city>Hong Kong</city>
        <zip>852</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>July 20, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>December 10, 2015</last_update_submitted>
  <last_update_submitted_qc>December 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Frozen thawed embryo transfer</keyword>
  <keyword>Endometrial injury</keyword>
  <keyword>Ongoing pregnancy rates</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <!-- 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/NCT02197832
org study id: HKU-VL-FETEA
nct id: NCT02197832
lead sponsor: 
has dmc: No
This is a randomised controlled trial on the effect of endometrial injury in the cycle
      preceding the frozen-thawed embryo transfer (FET) cycles. The study hypothesis is that
      endometrial injury will increase the ongoing pregnancy rate in FET cycles.
Consecutive women attending subfertility clinic at Queen Mary Hospital, University of Hong
      Kong who are scheduled for FET treatment will be recruited. Women who have normal uterine
      cavity will be randomized into study and control groups in 1 to 1 ratio according to a
      computer-generated randomization list.

      For patients in the study group, in the cycle immediately preceding the scheduled FET
      treatment, an endometrial biopsy would be arranged on day 21-23 of the menstrual cycles and
      they will be instructed to use non-hormonal means of contraception during that cycle. For
      patient in the control group, a similar procedure would be performed on the same timing
      during the preceding cycles without entering the uterine cavity, ie endometrial biopsy
      catheter entering the endocervical canal without entering the endometrial cavity. All
      patients will then proceed to FET treatment in the next cycle as scheduled.

      The FET would be carried out as per our protocol. In short, patients attend the clinic daily
      from 18 days before the next expected period for the determination of serum E2 and
      luteinising hormone (LH) concentrations until the LH surge, which was defined as the day on
      which the LH level was above 20 IU/L and doubled the average of the LH levels over the past
      three days. For patients with irregular menstrual cycles or no ovulation demonstrated during
      natural cycle monitoring, clomiphene citrate (CC, Clomid, Merrell, Staines, U.K.) 50-100 mg
      will be given daily for five days from Days 3-7. The cycle will be monitored by blood tests
      from day 10 of the cycle as above. FET was performed on the third day after the LH surge. Up
      to two frozen-thawed embryo(s) can be transferred. No luteal phase support is used. On-going
      pregnancy rates, defined as viable fetuses beyond 10-12 gestational weeks, between the two
      groups will be compared.

      We should measure endometrial thickness on LH+1 in natural and clomid-induced cycles.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Ongoing pregnancy rate
time frame: pregnancy at 10-12 weeks
description: Pregnancy at 10-12 weeks
measure: Implantation rate
time frame: 4-6 weeks after embryo transfer
description: Implantation rate = number of gestation sacs on ultrasound (USG) / number of embryos transferred
measure: Clinical pregnancy rate
time frame: 6 weeks after embryo transfer
description: Clinical pregnancy rate is the presence of gestation sac on USG scan.
arm group label: EA
arm group type: Experimental
description: in the cycle immediately preceding the scheduled FET treatment, an endometrial biopsy would be arranged on day 21-23 of the menstrual cycles and they will be instructed to use non-hormonal means of contraception during that cycle.
arm group label: Control
arm group type: Placebo Comparator
description: The procedure was performed in a standard approach using a Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France). The pipelle catheter was introduced through the cervix but not into the uterine cavity, only entering the endocervical canal as control.
intervention type: Procedure
intervention name: Endometrial biopsy
description: The procedure was performed in a standard approach using a Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France). The pipelle catheter was introduced through the cervix up to the uterine fundus. The piston was drawn back to the end of the sheath to create a negative pressure. The sheath was rotated and moved back and forth between the fundus and internal os for at least 3-4 times before it was gently withdrawn.
arm group label: EA
intervention type: Procedure
intervention name: control procedure
description: Using pipelle catheter without entering the uterine cavity.
arm group label: Control
intervention type: Device
intervention name: Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France)
arm group label: Control
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Vivian CY Lee, MBBS
role: Principal Investigator
affiliation: Queen Mary Hospital / University of Hong Kong.
facility: 
country: Hong Kong
responsible party type: Sponsor
mesh term: Infertility