<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/NCT02186782</url>
  </required_header>
  <id_info>
    <org_study_id>ME1</org_study_id>
    <nct_id>NCT02186782</nct_id>
  </id_info>
  <brief_title>Concomitant CC and E2 Versus CC Alone in Ovulation Induction</brief_title>
  <official_title>Concomitant Clomiphene Citrate and Estradiol Versus Clomiphene Citrate Alone in Ovulation Induction: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maher elesawi kamel elesawi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effect of concomitant administration of&#xD;
      estradiol during use of clomiphene citrate (CC) for induction of ovulation in infertile&#xD;
      women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women will be randomly divided into two groups; CC-E2 group and CC group. Women in the CC-E2&#xD;
      group will receive CC (100 mg/day for 5 consecutive days from day 2 of cycle) and estradiol&#xD;
      (2 mg/day for 5 consecutive days from day 2 of cycle). Women in the CC group will receive CC&#xD;
      (100 mg/day for 5 consecutive days from day 2 of cycle) and placebo mimic estradiol (for 5&#xD;
      consecutive days from day 2 of cycle). Transvaginal sonography (TVS) scan will be performed&#xD;
      regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the&#xD;
      stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18&#xD;
      mm in diameter, final oocyte maturation will be induced by intramuscular administration of&#xD;
      10000 IU of human chorionic gonadotropin (HCG) and timed intercourse will be advised. If&#xD;
      there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth&#xD;
      will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be&#xD;
      documented by TVS scan one week after triggering of oocyte maturation and will be confirmed&#xD;
      by assessing the midluteal serum progesterone level. Each woman will be subjected to ovarian&#xD;
      stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or&#xD;
      second cycle.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">August 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</primary_completion_date>
  <phase>Phase 4</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>6-8 weeks gestational age</time_frame>
    <description>Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 6-8 weeks gestational age) divided by the number of women</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Endometrial thickness on day of HCG administration</measure>
    <time_frame>3 months</time_frame>
    <description>Endometrial thickness by TVS on day of HCG administration</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Ovulation rate</measure>
    <time_frame>3 months</time_frame>
    <description>Number of ovulatory cycles divided by the number of stimulation cycles</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of ovarian follicles ≥ 18 mm on day of HCG administration</measure>
    <time_frame>3 months</time_frame>
    <description>Number of ovarian follicles ≥ 18 mm by TVS on day of HCG administration</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Infertility</condition>
  <condition>Anovulation</condition>
  <arm_group>
    <arm_group_label>Clomiphene citrate-Estradiol group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women will receive clomiphene citrate and estradiol</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clomiphene citrate group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women will receive clomiphene citrate and placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clomiphene citrate and Estradiol</intervention_name>
    <description>Women will receive clomiphene citrate (100 mg/day for 5 consecutive days from day 2 of cycle) and estradiol (2 mg/day for 5 consecutive days from day 2 of cycle)</description>
    <arm_group_label>Clomiphene citrate-Estradiol group</arm_group_label>
    <other_name>Clomid and Estradiol valerate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clomiphene citrate and Placebo</intervention_name>
    <description>Women will receive clomiphene citrate (100 mg/day for 5 consecutive days from day 2 of cycle) and placebo (for 5 consecutive days from day 2 of cycle)</description>
    <arm_group_label>Clomiphene citrate group</arm_group_label>
    <other_name>Clomid and Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infertile women with eugonadotrophic anovulation/oligoovulation.&#xD;
&#xD;
          -  Unexplained infertility.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 20 or &gt; 35 years.&#xD;
&#xD;
          -  Body mass index (BMI) &lt; 18.5 kg/m2 or &gt; 25 kg/m2.&#xD;
&#xD;
          -  Presence of any infertility factor other than anovulation/oligoovulation.&#xD;
&#xD;
          -  Previous history of ovarian surgery or surgical removal of one ovary.&#xD;
&#xD;
          -  Previous exposure to cytotoxic drugs or pelvic irradiation.&#xD;
&#xD;
          -  Metabolic or hormonal abnormalities.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed M Badawy, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Maher E Kamel Elesawi, Dr</last_name>
    <role>Study Director</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed S Abdelhafez, Dr</last_name>
    <role>Study Director</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maher E Kamel Elesawi, Dr</last_name>
    <phone>+201016103662</phone>
    <email>maherelesawi@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ahmed M Badawy, Prof</last_name>
    <phone>+201282848485</phone>
    <email>ambadawy@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Obstetrics and Gynecology Department in Mansoura University Hospital</name>
      <address>
        <city>Mansoura</city>
        <state>Dakahlia</state>
        <zip>35111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Private practice settings</name>
      <address>
        <city>Mansoura</city>
        <state>Dakahlia</state>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed M Badawy, Prof</last_name>
      <phone>+201282848485</phone>
      <email>ambadawy@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Ahmed M Badaway, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Private practice settings</name>
      <address>
        <city>Mit Ghamr</city>
        <state>Dakahlia</state>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maher E Kamel Elesawi, Dr</last_name>
      <phone>+20104523494</phone>
      <email>maherelesawi@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Maher E Kamel Elesawi, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>June 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>March 21, 2017</last_update_submitted>
  <last_update_submitted_qc>March 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Maher elesawi kamel elesawi</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>Clomiphene citrate</keyword>
  <keyword>Estradiol</keyword>
  <keyword>Endometrial thickness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Anovulation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Citric Acid</mesh_term>
    <mesh_term>Sodium Citrate</mesh_term>
    <mesh_term>Estradiol 17 beta-cypionate</mesh_term>
    <mesh_term>Estradiol 3-benzoate</mesh_term>
    <mesh_term>Clomiphene</mesh_term>
    <mesh_term>Enclomiphene</mesh_term>
    <mesh_term>Zuclomiphene</mesh_term>
    <mesh_term>Estradiol</mesh_term>
    <mesh_term>Polyestradiol phosphate</mesh_term>
  </intervention_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/NCT02186782
org study id: ME1
nct id: NCT02186782
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the effect of concomitant administration of
      estradiol during use of clomiphene citrate (CC) for induction of ovulation in infertile
      women.
Women will be randomly divided into two groups; CC-E2 group and CC group. Women in the CC-E2
      group will receive CC (100 mg/day for 5 consecutive days from day 2 of cycle) and estradiol
      (2 mg/day for 5 consecutive days from day 2 of cycle). Women in the CC group will receive CC
      (100 mg/day for 5 consecutive days from day 2 of cycle) and placebo mimic estradiol (for 5
      consecutive days from day 2 of cycle). Transvaginal sonography (TVS) scan will be performed
      regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the
      stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18
      mm in diameter, final oocyte maturation will be induced by intramuscular administration of
      10000 IU of human chorionic gonadotropin (HCG) and timed intercourse will be advised. If
      there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth
      will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be
      documented by TVS scan one week after triggering of oocyte maturation and will be confirmed
      by assessing the midluteal serum progesterone level. Each woman will be subjected to ovarian
      stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or
      second cycle.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Clinical pregnancy rate
time frame: 6-8 weeks gestational age
description: Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 6-8 weeks gestational age) divided by the number of women
measure: Endometrial thickness on day of HCG administration
time frame: 3 months
description: Endometrial thickness by TVS on day of HCG administration
measure: Ovulation rate
time frame: 3 months
description: Number of ovulatory cycles divided by the number of stimulation cycles
measure: Number of ovarian follicles ≥ 18 mm on day of HCG administration
time frame: 3 months
description: Number of ovarian follicles ≥ 18 mm by TVS on day of HCG administration
arm group label: Clomiphene citrate-Estradiol group
arm group type: Active Comparator
description: Women will receive clomiphene citrate and estradiol
arm group label: Clomiphene citrate group
arm group type: Active Comparator
description: Women will receive clomiphene citrate and placebo
intervention type: Drug
intervention name: Clomiphene citrate and Estradiol
description: Women will receive clomiphene citrate (100 mg/day for 5 consecutive days from day 2 of cycle) and estradiol (2 mg/day for 5 consecutive days from day 2 of cycle)
arm group label: Clomiphene citrate-Estradiol group
other name: Clomid and Estradiol valerate
intervention type: Drug
intervention name: Clomiphene citrate and Placebo
description: Women will receive clomiphene citrate (100 mg/day for 5 consecutive days from day 2 of cycle) and placebo (for 5 consecutive days from day 2 of cycle)
arm group label: Clomiphene citrate group
other name: Clomid and Placebo
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 39 Years
healthy volunteers: No
last name: Ahmed M Badawy, Prof
role: Principal Investigator
affiliation: Mansoura University
last name: Maher E Kamel Elesawi, Dr
role: Study Director
affiliation: Mansoura University
last name: Mohamed S Abdelhafez, Dr
role: Study Director
affiliation: Mansoura University
last name: Maher E Kamel Elesawi, Dr
phone: +201016103662
email: maherelesawi@yahoo.com
last name: Ahmed M Badawy, Prof
phone: +201282848485
email: ambadawy@yahoo.com
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Mansoura University
investigator full name: Maher elesawi kamel elesawi
investigator title: Dr
mesh term: Infertility
mesh term: Anovulation
mesh term: Citric Acid
mesh term: Sodium Citrate
mesh term: Estradiol 17 beta-cypionate
mesh term: Estradiol 3-benzoate
mesh term: Clomiphene
mesh term: Enclomiphene
mesh term: Zuclomiphene
mesh term: Estradiol
mesh term: Polyestradiol phosphate
sharing ipd: Undecided