<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/NCT03023774</url>
  </required_header>
  <id_info>
    <org_study_id>ABT-1233-RV</org_study_id>
    <nct_id>NCT03023774</nct_id>
  </id_info>
  <brief_title>Use of Gcsf in Patients With Recurrent Ivf/Icsi Failure</brief_title>
  <official_title>Effects of Granulocyte Colony-stimulating Factor (GCSF)-Neupogen on Cases With Thin Endometrium or Previous Implantation Failure in ICSI Cycles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams Maternity Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams Maternity Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the effectiveness of granulocyte colony-stimulating factor (GCSF) in the treatment&#xD;
      of thin endometrium or in women with recurrent implantation failure in ICSI cycles&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective analytical study which will be conducted at a private IVF center starting from&#xD;
      june 2016.&#xD;
&#xD;
      the study will be recruited from both the fertility clinics and centers by fulfilling&#xD;
      inclusion and exclusion criteria , all patient will be subjected to complete history taking&#xD;
      medical and fertility history including previous induction or implantation failure.&#xD;
&#xD;
      patients will be randomized into two groups, group A will be treated with neupogen 30&#xD;
      international unit (IU) and group B will be treated with clexane 40mg and estrogen.&#xD;
&#xD;
      study procedure: ovaries were stimulated with standard protocol (long GnRH Agonist) or&#xD;
      gonadotrophic releasing hormone (GnRH Antagonist, when at least 3 follicles achieved 18 mm&#xD;
      diameter, Human chorionic gonadotrophic (hCG) (10000 IU) was administered for ovulation&#xD;
      triggering, transvaginal oocyte retrieval was performed at 36-38 hours after injection of hCG&#xD;
      . the oocytes were fertilized by intracytoplasmic sperm injection (ICSI) method. the&#xD;
      thickness of endometrium was evaluated on the day of oocyte retrieval and syringe which&#xD;
      containing (300 mcg/1 ml) GCSF (neupogen) was infused slowly in the uterine cavity and after&#xD;
      5 days (before embryo transfer) endometrial thickness was evaluated again. all patients&#xD;
      received oral and parenteral progesterone for luteal phase support.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <phase>N/A</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>increase in endometrial thickness (above 7 mm)</measure>
    <time_frame>one week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>chemical pregnancy (serum beta hCG titre more than (25 mili liter international unit (mIU)/ml) and clinical pregnancy defined as the presence of an intrauterine gestational sac on transvaginal ultrasound (TVS)as 6 weeks.</measure>
    <time_frame>6 week</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Fertility Disorders</condition>
  <arm_group>
    <arm_group_label>neupogen</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>neupogen (granulocyte colony-stimulating factor) 30 IU once intrauterine at the time of ovum pickup</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Neupogen</intervention_name>
    <description>neupogen 30 IU once intrauterine at the time of ovum pickup</description>
    <arm_group_label>neupogen</arm_group_label>
    <other_name>granulocyte colony-stimulating factor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male partner with normal semen analysis according to world health organization (WHO)&#xD;
             2010.&#xD;
&#xD;
          -  female partner under the age of 36 presented with: a-thin endometrium (less 7 mm on&#xD;
             transvaginal ultrasound) or b- previous history multiple unexplained&#xD;
&#xD;
          -  female with no history of Asherman's syndrome , fibroids, and polyps in diagnostic&#xD;
             hysteroscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women with sickle cell disease, renal insufficiency, upper respiratory infection or&#xD;
             pneumonia, chronic neutropenia, known past or present malignancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>36 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 13, 2017</last_update_submitted>
  <last_update_submitted_qc>January 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams Maternity Hospital</investigator_affiliation>
    <investigator_full_name>Dr wessam magdi abuelghar</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lenograstim</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Female 35 years maximum have failed icsi due to low endometrium thickness</ipd_description>
  </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/NCT03023774
org study id: ABT-1233-RV
nct id: NCT03023774
lead sponsor: 
has dmc: Yes
Evaluate the effectiveness of granulocyte colony-stimulating factor (GCSF) in the treatment
      of thin endometrium or in women with recurrent implantation failure in ICSI cycles
Prospective analytical study which will be conducted at a private IVF center starting from
      june 2016.

      the study will be recruited from both the fertility clinics and centers by fulfilling
      inclusion and exclusion criteria , all patient will be subjected to complete history taking
      medical and fertility history including previous induction or implantation failure.

      patients will be randomized into two groups, group A will be treated with neupogen 30
      international unit (IU) and group B will be treated with clexane 40mg and estrogen.

      study procedure: ovaries were stimulated with standard protocol (long GnRH Agonist) or
      gonadotrophic releasing hormone (GnRH Antagonist, when at least 3 follicles achieved 18 mm
      diameter, Human chorionic gonadotrophic (hCG) (10000 IU) was administered for ovulation
      triggering, transvaginal oocyte retrieval was performed at 36-38 hours after injection of hCG
      . the oocytes were fertilized by intracytoplasmic sperm injection (ICSI) method. the
      thickness of endometrium was evaluated on the day of oocyte retrieval and syringe which
      containing (300 mcg/1 ml) GCSF (neupogen) was infused slowly in the uterine cavity and after
      5 days (before embryo transfer) endometrial thickness was evaluated again. all patients
      received oral and parenteral progesterone for luteal phase support.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: increase in endometrial thickness (above 7 mm)
time frame: one week
measure: chemical pregnancy (serum beta hCG titre more than (25 mili liter international unit (mIU)/ml) and clinical pregnancy defined as the presence of an intrauterine gestational sac on transvaginal ultrasound (TVS)as 6 weeks.
time frame: 6 week
arm group label: neupogen
arm group type: Other
description: neupogen (granulocyte colony-stimulating factor) 30 IU once intrauterine at the time of ovum pickup
intervention type: Drug
intervention name: Neupogen
description: neupogen 30 IU once intrauterine at the time of ovum pickup
arm group label: neupogen
other name: granulocyte colony-stimulating factor
criteria: 
gender: Female
minimum age: N/A
maximum age: 36 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Ain Shams Maternity Hospital
investigator full name: Dr wessam magdi abuelghar
investigator title: principal investigator
mesh term: Lenograstim
sharing ipd: Yes
ipd description: Female 35 years maximum have failed icsi due to low endometrium thickness