<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/NCT01665547</url>
  </required_header>
  <id_info>
    <org_study_id>lcpco</org_study_id>
    <nct_id>NCT01665547</nct_id>
  </id_info>
  <brief_title>Adding L-carnitine in Clomiphene Resistant Polycystic Ovary Improves the Quality of Ovulation and the Pregnancy Outcome</brief_title>
  <official_title>Adding L-carnitine in Clomiphene Resistant Pco Improves the Quality of Ovulation and the Pregnancy Outcome,a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Woman's Health University Hospital, Egypt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Woman's Health University Hospital, Egypt</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adding L-carnitine is more successful than clomiphene as a first line therapy for ovulation&#xD;
      induction in women with clomiphene resistant PCOS&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients younger than 35 years, presenting with primary or secondary infertility following&#xD;
      regular intercourse for at least 1 year and diagnosed with PCO according to Rotterdam's&#xD;
      criteria who had received five unsuccessful clomiphene citrate-timed intercourse stimulation&#xD;
      cycles were included.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>July 2012</start_date>
  <completion_date type="Anticipated">September 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ovulation induction</measure>
    <time_frame>0ne year</time_frame>
    <description>is to study the efficacy of l-carnitine in inducing ovulation in clomiphene resistant pco</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pregnancy</measure>
    <time_frame>0ne year</time_frame>
    <description>the occurrence of pregnancy and the rate of continuation of pregnancy till end of the first trimester</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">157</enrollment>
  <condition>Treatment Resistant Disorders</condition>
  <arm_group>
    <arm_group_label>l-carnitine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>adding 3gm l-carnitine from day 1 to day 12 of induced the menstrual cycle by 50 mg clomiphene</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>l-carnitine</intervention_name>
    <description>3gm l-carnitine from day 1 to day 12 of the menstrual cycle</description>
    <arm_group_label>l-carnitine</arm_group_label>
    <other_name>carivita,l-carnitol</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients younger than 35 years, presenting with primary or secondary infertility&#xD;
             following regular intercourse for at least 1 year and diagnosed with PCO according to&#xD;
             Rotterdam's criteria who had received five unsuccessful clomiphene citrate-timed&#xD;
             intercourse stimulation cycles were included. The diagnosis was based on a complete&#xD;
             history taking, physical examination and a paper documented complete infertility&#xD;
             work-up within the previous 6 months, either conducted within the setting of the&#xD;
             hospital or at a licensed infertility management clinic.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age more than 40 years,&#xD;
&#xD;
          -  tubal,uterine or male factor infertility&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alaa M Ismail, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Women's Health Hospital</affiliation>
  </overall_official>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>July 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>September 9, 2013</last_update_submitted>
  <last_update_submitted_qc>September 9, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Woman's Health University Hospital, Egypt</investigator_affiliation>
    <investigator_full_name>alaa eldeen mahmoud ismail</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>clomiphene resistant</keyword>
  <keyword>pcos</keyword>
  <keyword>induction of ovulation</keyword>
  <keyword>l-carnitine</keyword>
  <!-- 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/NCT01665547
org study id: lcpco
nct id: NCT01665547
lead sponsor: 
has dmc: Yes
Adding L-carnitine is more successful than clomiphene as a first line therapy for ovulation
      induction in women with clomiphene resistant PCOS
Patients younger than 35 years, presenting with primary or secondary infertility following
      regular intercourse for at least 1 year and diagnosed with PCO according to Rotterdam's
      criteria who had received five unsuccessful clomiphene citrate-timed intercourse stimulation
      cycles were included.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: ovulation induction
time frame: 0ne year
description: is to study the efficacy of l-carnitine in inducing ovulation in clomiphene resistant pco
measure: pregnancy
time frame: 0ne year
description: the occurrence of pregnancy and the rate of continuation of pregnancy till end of the first trimester
arm group label: l-carnitine
arm group type: Active Comparator
description: adding 3gm l-carnitine from day 1 to day 12 of induced the menstrual cycle by 50 mg clomiphene
intervention type: Drug
intervention name: l-carnitine
description: 3gm l-carnitine from day 1 to day 12 of the menstrual cycle
arm group label: l-carnitine
other name: carivita,l-carnitol
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alaa M Ismail, M.D
role: Principal Investigator
affiliation: Women's Health Hospital
responsible party type: Principal Investigator
investigator affiliation: Woman's Health University Hospital, Egypt
investigator full name: alaa eldeen mahmoud ismail
investigator title: assistant professor