<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/NCT02250768</url>
  </required_header>
  <id_info>
    <org_study_id>CGRH-Embryogen</org_study_id>
    <nct_id>NCT02250768</nct_id>
  </id_info>
  <brief_title>Effects of Embryogen in RIF Patients</brief_title>
  <acronym>RIF</acronym>
  <official_title>Effects of Granulocyte - Macrophage Colony - Stimulating Factor (GM-CSF) Supplementation in Embryo Culture in Patients With Repeated Implantation Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vietnam National University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vietnam National University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to investigate the potential effects of Granulocyte-Macrophage&#xD;
      Stimulating-Colony Factor (GM-CSF) supplementation in embryo culture for patients with&#xD;
      repeated implantation failure (RIF)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      60 patients with repeated implantation failure were involved.&#xD;
&#xD;
      RIF was defined as patients failed to conceive (beta-hCG &lt; 5 mIU/mL) after at least 03 embryo&#xD;
      transfers (fresh and frozen) with 06 top quality embryos or more.&#xD;
&#xD;
      Ovarian stimulation was performed using GnRH antagonist protocol. All matured oocytes were&#xD;
      inseminated by ICSI. Injected oocytes were cultured in medium supplemented with 2ng/ml of&#xD;
      GM-CSF (Embryogen, Origio) until day of transfer. Embryo evaluation was performed at ﬁxed&#xD;
      time points of 18 and 44 hour after fertilization. Embryo transfer was performed 2 days after&#xD;
      ovum retrieval.&#xD;
&#xD;
      Luteal-phase support was provided using progesterone gel (Crinone 8% 90 mg, twice a day;&#xD;
      Merck Serono) and estradiol per os (Valiera 2mg, twice a day; Laboratorios Recalcine). Serum&#xD;
      hCG was measured 16 days after oocyte retrieval, and if positive, an ultrasound scan was&#xD;
      performed at gestational weeks 7 and 12.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ongoing pregnancy rate</measure>
    <time_frame>12 week of gestation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implantation rate</measure>
    <time_frame>7 week of gestation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>clinical pregnancy rate</measure>
    <time_frame>7 week of gestation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>top quality embryo rate</measure>
    <time_frame>44 hours after insemination</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>GM-CSF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Injected oocytes were cultured in GM-CSF supplemented media until day of transfer</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>GM-CSF</intervention_name>
    <description>2ng/ml of GM-CSF supplemented into culture media</description>
    <arm_group_label>GM-CSF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal ovarian reserve (AMH &gt; 1.1 ng/ml)&#xD;
&#xD;
          -  Regular menstrual cycle (25 - 34 days)&#xD;
&#xD;
          -  Clear informations about at least 3 latest IVF/ET&#xD;
&#xD;
          -  Fresh embryo transfer in this cycle&#xD;
&#xD;
          -  Endometrial thickness of 10 mm or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Undergo oocyte donation or in vitro maturation (IVM) cycles&#xD;
&#xD;
          -  Using frozen or surgically retrieved sperm&#xD;
&#xD;
          -  Adenomyosis, Uterine anomaly, uterine fibroid, hydrosalpinges&#xD;
&#xD;
          -  In participation in other studies/interventions&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vinh Q Dang, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Center for Genetics and Reproductive Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>An Sinh Hospital</name>
      <address>
        <city>Ho Chi Minh</city>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>September 23, 2014</last_update_submitted>
  <last_update_submitted_qc>September 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vietnam National University</investigator_affiliation>
    <investigator_full_name>Dang Quang Vinh</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>GM-CSF, repeated implantation failure</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/NCT02250768
org study id: CGRH-Embryogen
nct id: NCT02250768
lead sponsor: 
has dmc: No
The purpose of this study was to investigate the potential effects of Granulocyte-Macrophage
      Stimulating-Colony Factor (GM-CSF) supplementation in embryo culture for patients with
      repeated implantation failure (RIF)
60 patients with repeated implantation failure were involved.

      RIF was defined as patients failed to conceive (beta-hCG < 5 mIU/mL) after at least 03 embryo
      transfers (fresh and frozen) with 06 top quality embryos or more.

      Ovarian stimulation was performed using GnRH antagonist protocol. All matured oocytes were
      inseminated by ICSI. Injected oocytes were cultured in medium supplemented with 2ng/ml of
      GM-CSF (Embryogen, Origio) until day of transfer. Embryo evaluation was performed at ﬁxed
      time points of 18 and 44 hour after fertilization. Embryo transfer was performed 2 days after
      ovum retrieval.

      Luteal-phase support was provided using progesterone gel (Crinone 8% 90 mg, twice a day;
      Merck Serono) and estradiol per os (Valiera 2mg, twice a day; Laboratorios Recalcine). Serum
      hCG was measured 16 days after oocyte retrieval, and if positive, an ultrasound scan was
      performed at gestational weeks 7 and 12.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: ongoing pregnancy rate
time frame: 12 week of gestation
measure: Implantation rate
time frame: 7 week of gestation
measure: clinical pregnancy rate
time frame: 7 week of gestation
measure: top quality embryo rate
time frame: 44 hours after insemination
arm group label: GM-CSF
arm group type: Experimental
description: Injected oocytes were cultured in GM-CSF supplemented media until day of transfer
intervention type: Biological
intervention name: GM-CSF
description: 2ng/ml of GM-CSF supplemented into culture media
arm group label: GM-CSF
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Vinh Q Dang, Dr
role: Principal Investigator
affiliation: Research Center for Genetics and Reproductive Health
facility: 
country: Vietnam
responsible party type: Principal Investigator
investigator affiliation: Vietnam National University
investigator full name: Dang Quang Vinh
investigator title: Dr
mesh term: Infertility