<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/NCT03824340</url>
  </required_header>
  <id_info>
    <org_study_id>ICSI preparation</org_study_id>
    <nct_id>NCT03824340</nct_id>
  </id_info>
  <brief_title>Intracytoplasmic Sperm Injection Preparation in Infertile Women</brief_title>
  <official_title>Intracytoplasmic Sperm Injection Preparation in Infertile Women With Unexplained Infertility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aljazeera Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aljazeera Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Infertility is a common gynecological problem is women&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intracytoplasmic sperm injection is one of the aisted reproduction techniques that help to&#xD;
      solve this problem&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 30, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 30, 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>
    <intervention_model_description>A randomized controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the number of women who will have successful ICSI</measure>
    <time_frame>within 4 months</time_frame>
    <description>The number of women who will get pregnant after ICSI with extra treatment</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Doxycycline before ICSI</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>extra medications (Doxycycline ) group before ICSI : in which Women who will receive the Doxyxycline before ICSI Intervention : Women will receive Doxycycline before ICSI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>control group : No intervention : in which Women willnot receive the extra medications (Doxycycline ) before ICSI</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxycycline before ICSI</intervention_name>
    <description>Extra medication (Doxycycline ) group before ICSI :,women who will receive more medications (Doxycycline ) before starting the ICSI process</description>
    <arm_group_label>Doxycycline before ICSI</arm_group_label>
    <other_name>Medical treatment with Doxycycline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women who have infertility with age between 20 -42 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women who has ovarian or endometrial factor of infertility&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>infertile women</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmoud Alalfy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mahmoud Alalfy, PhD</last_name>
    <phone>01002611058</phone>
    <email>mahmoudalalfy@ymail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Algazeerah</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mahmoud Alalfy, master</last_name>
      <phone>+201002611058</phone>
      <email>mahmoudalalfy@ymail.com</email>
    </contact>
    <contact_backup>
      <last_name>Ahmed Elgazzar, M.D</last_name>
      <phone>+201014005959</phone>
    </contact_backup>
    <investigator>
      <last_name>Mahmoud Alalfy, master</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>August 4, 2019</last_update_submitted>
  <last_update_submitted_qc>August 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Doxycycline</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/NCT03824340
org study id: ICSI preparation
nct id: NCT03824340
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Infertility is a common gynecological problem is women
Intracytoplasmic sperm injection is one of the aisted reproduction techniques that help to
      solve this problem
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomized controlled study
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: the number of women who will have successful ICSI
time frame: within 4 months
description: The number of women who will get pregnant after ICSI with extra treatment
arm group label: Doxycycline before ICSI
arm group type: Active Comparator
description: extra medications (Doxycycline ) group before ICSI : in which Women who will receive the Doxyxycline before ICSI Intervention : Women will receive Doxycycline before ICSI
arm group label: control group
arm group type: No Intervention
description: control group : No intervention : in which Women willnot receive the extra medications (Doxycycline ) before ICSI
intervention type: Drug
intervention name: Doxycycline before ICSI
description: Extra medication (Doxycycline ) group before ICSI :,women who will receive more medications (Doxycycline ) before starting the ICSI process
arm group label: Doxycycline before ICSI
other name: Medical treatment with Doxycycline
criteria: 
gender: Female
gender based: Yes
gender description: infertile women
minimum age: 20 Years
maximum age: 42 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mahmoud Alalfy, PhD
role: Principal Investigator
affiliation: Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
last name: Mahmoud Alalfy, PhD
phone: 01002611058
email: mahmoudalalfy@ymail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Egypt
responsible party type: Sponsor
mesh term: Infertility
mesh term: Doxycycline