<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/NCT03006406</url>
  </required_header>
  <id_info>
    <org_study_id>ENDO-1</org_study_id>
    <nct_id>NCT03006406</nct_id>
  </id_info>
  <brief_title>Effect of Shorten Gonadotropin-releasing Hormone Agonist Therapy on the Outcome of in Vitro Fertilization-Embryo Transfer in Patients With Endometriosis</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Zhengzhou University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Zhengzhou University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gonadotropin-releasing hormone analogue (GnRH-a) is a synthetic decapeptide compound which&#xD;
      can down-regulate pituitary function causing a temporary low estrogen state. Since&#xD;
      endometriosis is an estrogen-dependent disease, the use of long-acting GnRH-a can control the&#xD;
      growth of endometriosis by inhibiting ovary function.Some scholars have found that, for&#xD;
      adenomyosis patients who received a super long protocol (pretreatment of long-acting GnRH-a&#xD;
      for 1-2 months) in IVF treatment, the pregnancy outcome is comparable to that of the controls&#xD;
      with normal uterus. Thus, the aim of this study is to compare the clinical pregnancy rate in&#xD;
      patients treated with GnRH-a for 1, or 2 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2016</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">January 2017</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical pregnancy rate</measure>
    <time_frame>5 weeks after embryo transfer</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of oocytes retrieved</measure>
    <time_frame>1 day at oocyte retrieved day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2 pronucleus(2PN)fertilization rate</measure>
    <time_frame>48hours after oocyte retrieved day</time_frame>
    <description>Number of 2PN/Matured oocytes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Clinical Pregnancy Rate</condition>
  <arm_group>
    <arm_group_label>Long term GnRH-a for 1 month</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patient in this group only receive GnRH-a 3.75 for 1 month</description>
  </arm_group>
  <arm_group>
    <arm_group_label>patient in this group only receive GnRH-a 3.75 for 2 month</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patient in this group only receive GnRH-a 3.75 for 2 month</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Long term GnRH-a (3.75mg)</intervention_name>
    <description>patient in this group only receive GnRH-a 3.75 for pituitary down-regulation</description>
    <arm_group_label>Long term GnRH-a for 1 month</arm_group_label>
    <arm_group_label>patient in this group only receive GnRH-a 3.75 for 2 month</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first IVF cycle;&#xD;
&#xD;
          -  with normal ovarian reserve(FSH(10miu/ml； antral follicle count )3)&#xD;
&#xD;
          -  with normal uterine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-implantation genetic diagnosis cycles;&#xD;
&#xD;
          -  Oocyte donation cycles&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Huijuan Kong, M.D.</last_name>
    <phone>86-371-67966161</phone>
    <email>luckyjuanjuan819@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450052</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yingpu Ms Sun, M.D,PhD</last_name>
      <phone>86-13803841888</phone>
      <email>syp2008@vip.sina.com</email>
    </contact>
    <contact_backup>
      <last_name>Zhiqin Mr Bu, MD</last_name>
      <phone>86-15981978863</phone>
      <email>rmczzu@126.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>van der Houwen LE, Mijatovic V, Leemhuis E, Schats R, Heymans MW, Lambalk CB, Hompes PG. Efficacy and safety of IVF/ICSI in patients with severe endometriosis after long-term pituitary down-regulation. Reprod Biomed Online. 2014 Jan;28(1):39-46. doi: 10.1016/j.rbmo.2013.09.027. Epub 2013 Oct 9.</citation>
    <PMID>24262434</PMID>
  </reference>
  <reference>
    <citation>Mijatovic V, Florijn E, Halim N, Schats R, Hompes P. Adenomyosis has no adverse effects on IVF/ICSI outcomes in women with endometriosis treated with long-term pituitary down-regulation before IVF/ICSI. Eur J Obstet Gynecol Reprod Biol. 2010 Jul;151(1):62-5. doi: 10.1016/j.ejogrb.2010.02.047. Epub 2010 Apr 21.</citation>
    <PMID>20409633</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital of Zhengzhou University</investigator_affiliation>
    <investigator_full_name>Yingpu Sun</investigator_full_name>
    <investigator_title>Director of Reproductive Medical Center,1st Affilated Hospital, Zhengzhou University</investigator_title>
  </responsible_party>
  <keyword>endometriosis</keyword>
  <keyword>long term GnRH-a</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</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/NCT03006406
org study id: ENDO-1
nct id: NCT03006406
lead sponsor: 
has dmc: No
Gonadotropin-releasing hormone analogue (GnRH-a) is a synthetic decapeptide compound which
      can down-regulate pituitary function causing a temporary low estrogen state. Since
      endometriosis is an estrogen-dependent disease, the use of long-acting GnRH-a can control the
      growth of endometriosis by inhibiting ovary function.Some scholars have found that, for
      adenomyosis patients who received a super long protocol (pretreatment of long-acting GnRH-a
      for 1-2 months) in IVF treatment, the pregnancy outcome is comparable to that of the controls
      with normal uterus. Thus, the aim of this study is to compare the clinical pregnancy rate in
      patients treated with GnRH-a for 1, or 2 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: clinical pregnancy rate
time frame: 5 weeks after embryo transfer
measure: Number of oocytes retrieved
time frame: 1 day at oocyte retrieved day
measure: 2 pronucleus(2PN)fertilization rate
time frame: 48hours after oocyte retrieved day
description: Number of 2PN/Matured oocytes
arm group label: Long term GnRH-a for 1 month
arm group type: Active Comparator
description: patient in this group only receive GnRH-a 3.75 for 1 month
arm group label: patient in this group only receive GnRH-a 3.75 for 2 month
arm group type: Experimental
description: patient in this group only receive GnRH-a 3.75 for 2 month
intervention type: Drug
intervention name: Long term GnRH-a (3.75mg)
description: patient in this group only receive GnRH-a 3.75 for pituitary down-regulation
arm group label: Long term GnRH-a for 1 month
arm group label: patient in this group only receive GnRH-a 3.75 for 2 month
criteria: 
gender: Female
minimum age: 22 Years
maximum age: 42 Years
healthy volunteers: No
last name: Huijuan Kong, M.D.
phone: 86-371-67966161
email: luckyjuanjuan819@126.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
citation: van der Houwen LE, Mijatovic V, Leemhuis E, Schats R, Heymans MW, Lambalk CB, Hompes PG. Efficacy and safety of IVF/ICSI in patients with severe endometriosis after long-term pituitary down-regulation. Reprod Biomed Online. 2014 Jan;28(1):39-46. doi: 10.1016/j.rbmo.2013.09.027. Epub 2013 Oct 9.
PMID: 24262434
citation: Mijatovic V, Florijn E, Halim N, Schats R, Hompes P. Adenomyosis has no adverse effects on IVF/ICSI outcomes in women with endometriosis treated with long-term pituitary down-regulation before IVF/ICSI. Eur J Obstet Gynecol Reprod Biol. 2010 Jul;151(1):62-5. doi: 10.1016/j.ejogrb.2010.02.047. Epub 2010 Apr 21.
PMID: 20409633
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital of Zhengzhou University
investigator full name: Yingpu Sun
investigator title: Director of Reproductive Medical Center,1st Affilated Hospital, Zhengzhou University
mesh term: Endometriosis
sharing ipd: Undecided