<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/NCT03796130</url>
  </required_header>
  <id_info>
    <org_study_id>H0008</org_study_id>
    <nct_id>NCT03796130</nct_id>
  </id_info>
  <brief_title>Does Myomectomy for Intramural Fibroid Improve ART Outcome?</brief_title>
  <acronym>MIFART</acronym>
  <official_title>Does Myomectomy for Intramural Fibroid Improve ART Outcome? A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sohag University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mansoura University</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>
      Intamural fibroids (myoma) do exist in some infertile women undergoing IVF treatment. There&#xD;
      is controversy whether myomectomy before IVF treatment could improve IVF outcome. This trial&#xD;
      will examine whether myomectomy in those patients could improve the results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will include women who have intramural myoma ranging from 3-5 cm&#xD;
&#xD;
      The participants will be randomly allocated into two groups.&#xD;
&#xD;
      In group (1): myomectomy will be performed before ART&#xD;
&#xD;
      In group (2):women will have their trial of ART without myomectomy&#xD;
&#xD;
      In group A, ART will be performed 3 months after myomectomy if the uterine cavity is not&#xD;
      opened and 6 months after myomectomy upon inadvertent opening of the uterine cavity during&#xD;
      surgery&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2019</start_date>
  <completion_date type="Anticipated">April 2021</completion_date>
  <primary_completion_date type="Anticipated">April 2021</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary outcome will be ongoing pregnancy rate</measure>
    <time_frame>3 months after embryo transfer</time_frame>
    <description>Pregnancy continued after 12 week gestation per randomised women</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>-Implantation rate</measure>
    <time_frame>15 days after embryo transfer</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>-clinical pregnancy rate</measure>
    <time_frame>5 weeks after embryo transfer</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Fibroid Uterus</condition>
  <arm_group>
    <arm_group_label>(A)Myomectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This study will include women who have intramural myomas ranging from 3-5 cm&#xD;
The participants will be randomlyallocated intotwo groups.&#xD;
In group (A): myomectomy will be performed before ART&#xD;
In group 1, ART will be performed 3 months after myomectomy if the uterine cavity is not opened and 6 months after myomectomy upon inadvertent opening of the uterine cavity during surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>(B) No myomectomy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This study will include women who have intramural myomas ranging from 3-5 cm&#xD;
The participants will be randomly allocated into two groups.&#xD;
In group (B):women will have their trial of ART without myomectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Myomectomy</intervention_name>
    <description>This study will include women who have intramural myomas ranging from 3-5 cm&#xD;
The participants will be randomly allocated into two groups.&#xD;
In group (1): myomectomy will be performed before ART&#xD;
In group (2):women will have their trial of ART without myomectomy&#xD;
In group A, ART will be performed 3 months after myomectomy if the uterine cavity is not opened and 6 months after myomectomy upon inadvertent opening of the uterine cavity during surgery</description>
    <arm_group_label>(A)Myomectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria:&#xD;
&#xD;
          -  Women with intramural fibroid without any cavity involvement&#xD;
&#xD;
          -  Age ˂ 35 years&#xD;
&#xD;
          -  I onCSI or IVF cycles&#xD;
&#xD;
          -  normal uterine cavity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria:&#xD;
&#xD;
          -  low ovarian reserve (AFC &lt; 7 and or AMH &lt; 1.1 ng/ml)&#xD;
&#xD;
          -  Endometrioma&#xD;
&#xD;
          -  Untreated hydrosalpinx&#xD;
&#xD;
          -  Non obstructive azoospermia&#xD;
&#xD;
          -  Any other cavitary lesions (Asherman syndrome, Mullerian anomalies)&#xD;
&#xD;
          -  recurrent implantation failure&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Gibreel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed S Abdelhafez, MD</last_name>
    <role>Study Director</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Salah Rasheed, MD</last_name>
    <role>Study Director</role>
    <affiliation>Sohag University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ahmed Nasr, MD</last_name>
    <role>Study Director</role>
    <affiliation>Assiut Universit</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hisham A Saleh, MD</last_name>
    <role>Study Director</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hassan El Maghraby, MD</last_name>
    <role>Study Director</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eman El Gindy, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Zagazig University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hoda Sibai, MD</last_name>
    <role>Study Director</role>
    <affiliation>Zagazig University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hamed Yossef, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eman ElGindy, MD, PhD</last_name>
    <phone>01227491143</phone>
    <email>eman_elgindy2013@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mansoura University Hospital</name>
      <address>
        <city>Mansoura</city>
        <state>Dakahlia</state>
        <zip>35111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>December 13, 2019</last_update_submitted>
  <last_update_submitted_qc>December 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Ahmed Gibreel</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyoma</mesh_term>
    <mesh_term>Myofibroma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03796130
org study id: H0008
nct id: NCT03796130
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Intamural fibroids (myoma) do exist in some infertile women undergoing IVF treatment. There
      is controversy whether myomectomy before IVF treatment could improve IVF outcome. This trial
      will examine whether myomectomy in those patients could improve the results.
This study will include women who have intramural myoma ranging from 3-5 cm

      The participants will be randomly allocated into two groups.

      In group (1): myomectomy will be performed before ART

      In group (2):women will have their trial of ART without myomectomy

      In group A, ART will be performed 3 months after myomectomy if the uterine cavity is not
      opened and 6 months after myomectomy upon inadvertent opening of the uterine cavity during
      surgery
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: The primary outcome will be ongoing pregnancy rate
time frame: 3 months after embryo transfer
description: Pregnancy continued after 12 week gestation per randomised women
measure: -Implantation rate
time frame: 15 days after embryo transfer
measure: -clinical pregnancy rate
time frame: 5 weeks after embryo transfer
arm group label: (A)Myomectomy
arm group type: Experimental
description: This study will include women who have intramural myomas ranging from 3-5 cm
The participants will be randomlyallocated intotwo groups.
In group (A): myomectomy will be performed before ART
In group 1, ART will be performed 3 months after myomectomy if the uterine cavity is not opened and 6 months after myomectomy upon inadvertent opening of the uterine cavity during surgery
arm group label: (B) No myomectomy
arm group type: No Intervention
description: This study will include women who have intramural myomas ranging from 3-5 cm
The participants will be randomly allocated into two groups.
In group (B):women will have their trial of ART without myomectomy
intervention type: Procedure
intervention name: Myomectomy
description: This study will include women who have intramural myomas ranging from 3-5 cm
The participants will be randomly allocated into two groups.
In group (1): myomectomy will be performed before ART
In group (2):women will have their trial of ART without myomectomy
In group A, ART will be performed 3 months after myomectomy if the uterine cavity is not opened and 6 months after myomectomy upon inadvertent opening of the uterine cavity during surgery
arm group label: (A)Myomectomy
criteria: 
gender: Female
gender based: Yes
gender description: Women
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Ahmed Gibreel, MD
role: Principal Investigator
affiliation: Mansoura University
last name: Mohamed S Abdelhafez, MD
role: Study Director
affiliation: Mansoura University
last name: Salah Rasheed, MD
role: Study Director
affiliation: Sohag University
last name: Ahmed Nasr, MD
role: Study Director
affiliation: Assiut Universit
last name: Hisham A Saleh, MD
role: Study Director
affiliation: Alexandria University
last name: Hassan El Maghraby, MD
role: Study Director
affiliation: Alexandria University
last name: Eman El Gindy, MD
role: Study Chair
affiliation: Zagazig University
last name: Hoda Sibai, MD
role: Study Director
affiliation: Zagazig University
last name: Hamed Yossef, MD
role: Study Chair
affiliation: Mansoura University
last name: Eman ElGindy, MD, PhD
phone: 01227491143
email: eman_elgindy2013@hotmail.com
facility: 
status: Recruiting
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Ahmed Gibreel
investigator title: Assistant professor
mesh term: Leiomyoma
mesh term: Myofibroma
sharing ipd: Yes