<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/NCT04500743</url>
  </required_header>
  <id_info>
    <org_study_id>Dienogest before IVF</org_study_id>
    <nct_id>NCT04500743</nct_id>
  </id_info>
  <brief_title>Role of Suppression of Endometriosis With Progestins Before IVF-ET</brief_title>
  <official_title>Role of Suppression of Endometriosis With Progestins Before IVF-ET: a Non-inferiority Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Research Centre, Egypt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Research Centre, Egypt</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to assess the role of Dienogest pretreatment for endometriosis suppression&#xD;
      as compared to Gonadotropin-releasing hormone agonist (GnRHa) in patients with endometriosis&#xD;
      pursuing IVF treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">October 31, 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the number of retrieved oocytes</measure>
    <time_frame>After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)</time_frame>
    <description>the number of retrieved oocytes as the main concern was the effect of either GnRHa or Dienogest on ovarian responsiveness</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the fertilization rate</measure>
    <time_frame>After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)</time_frame>
    <description>defined as the number of zygotes with two pronuclei divided by the number of oocytes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the number of transferrable embryos</measure>
    <time_frame>After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)</time_frame>
    <description>defined as the number of embryos suitable for transfer in the stimulated cycle or cryopreservation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the cost of the treatment</measure>
    <time_frame>After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)</time_frame>
    <description>the cost of the treatment in Egyptian pounds including cost of pretreatment and ovarian stimulation drugs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pregnancy rate per cycle started</measure>
    <time_frame>After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)</time_frame>
    <description>defined as patients with positive urinary or serum pregnancy test divided by the number of patients starting the treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the clinical pregnancy rate per cycle started</measure>
    <time_frame>after women have postive pregnancy test (2 weeks after after the embryo transfer)</time_frame>
    <description>defined as the number of patients with at least one intrauterine gestational sac with identifiable fetal heart pulsations over the total number of patients starting the treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the miscarriage rate</measure>
    <time_frame>After occurence of the clinical pregnancy (5 months after after the embryo transfer)</time_frame>
    <description>defined as patients with identified intrauterine gestational sac without a fetal pole, or a fetal pole with no heart pulsations with no other viable fetuses over the number of patients with positive pregnancy test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient's quality of life</measure>
    <time_frame>throughout the pre-treatment with GnRHa or Dienogest as well as the induction of ovulation &quot;through study completion, an average of 9 months&quot;</time_frame>
    <description>patient's quality of life during the pretreatment period as assessed by the Fertility quality of life (FertiQoL) questionnaire with a range of 0 (the worst) to 100 (the best).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">134</enrollment>
  <condition>IVF</condition>
  <condition>Endometriosis</condition>
  <condition>Pregnancy Rate</condition>
  <condition>Progestins</condition>
  <condition>GnRH-analogue</condition>
  <arm_group>
    <arm_group_label>Dienogest</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>GnRH analogue</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dienogest</intervention_name>
    <description>Group B (n=67) who had daily oral Dienogest 2 mg/d for 3 months before starting standard long protocol for IVF</description>
    <arm_group_label>Dienogest</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>leuprorelin acetate</intervention_name>
    <description>Group A (n=67) who had monthly depot GnRHa for 3 months before ovarian stimulation in IVF treatment (Ultra-long protocol)</description>
    <arm_group_label>GnRH analogue</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  confirmed diagnosis of endometriosis&#xD;
&#xD;
          -  body mass index &lt; 35 Kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  if they have been already on long-term down-regulation of the pituitary gland with&#xD;
             GnRHa for control of endometriosis&#xD;
&#xD;
          -  liver or kidney disease&#xD;
&#xD;
          -  evidence of diminished ovarian reserve (e.g. high FSH level &gt;12 IU/L or low AMH level&#xD;
             &lt;1 ng/ml).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Minia Infertility research unit</name>
      <address>
        <city>Minya</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Research Centre, Egypt</investigator_affiliation>
    <investigator_full_name>Mazen Abdel Rasheed</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leuprolide</mesh_term>
    <mesh_term>Dienogest</mesh_term>
  </intervention_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/NCT04500743
org study id: Dienogest before IVF
nct id: NCT04500743
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study aimed to assess the role of Dienogest pretreatment for endometriosis suppression
      as compared to Gonadotropin-releasing hormone agonist (GnRHa) in patients with endometriosis
      pursuing IVF treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the number of retrieved oocytes
time frame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
description: the number of retrieved oocytes as the main concern was the effect of either GnRHa or Dienogest on ovarian responsiveness
measure: the fertilization rate
time frame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
description: defined as the number of zygotes with two pronuclei divided by the number of oocytes
measure: the number of transferrable embryos
time frame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
description: defined as the number of embryos suitable for transfer in the stimulated cycle or cryopreservation
measure: the cost of the treatment
time frame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
description: the cost of the treatment in Egyptian pounds including cost of pretreatment and ovarian stimulation drugs
measure: pregnancy rate per cycle started
time frame: After the ovarian induction (3 months after the pre treatment with either GnRHa or Dienogest)
description: defined as patients with positive urinary or serum pregnancy test divided by the number of patients starting the treatment
measure: the clinical pregnancy rate per cycle started
time frame: after women have postive pregnancy test (2 weeks after after the embryo transfer)
description: defined as the number of patients with at least one intrauterine gestational sac with identifiable fetal heart pulsations over the total number of patients starting the treatment
measure: the miscarriage rate
time frame: After occurence of the clinical pregnancy (5 months after after the embryo transfer)
description: defined as patients with identified intrauterine gestational sac without a fetal pole, or a fetal pole with no heart pulsations with no other viable fetuses over the number of patients with positive pregnancy test
measure: patient's quality of life
time frame: throughout the pre-treatment with GnRHa or Dienogest as well as the induction of ovulation "through study completion, an average of 9 months"
description: patient's quality of life during the pretreatment period as assessed by the Fertility quality of life (FertiQoL) questionnaire with a range of 0 (the worst) to 100 (the best).
arm group label: Dienogest
arm group type: Active Comparator
arm group label: GnRH analogue
arm group type: Active Comparator
intervention type: Drug
intervention name: Dienogest
description: Group B (n=67) who had daily oral Dienogest 2 mg/d for 3 months before starting standard long protocol for IVF
arm group label: Dienogest
intervention type: Drug
intervention name: leuprorelin acetate
description: Group A (n=67) who had monthly depot GnRHa for 3 months before ovarian stimulation in IVF treatment (Ultra-long protocol)
arm group label: GnRH analogue
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: National Research Centre, Egypt
investigator full name: Mazen Abdel Rasheed
investigator title: Principal Investigator
mesh term: Endometriosis
mesh term: Leuprolide
mesh term: Dienogest