<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/NCT02264847</url>
  </required_header>
  <id_info>
    <org_study_id>5102014</org_study_id>
    <secondary_id>A5102014</secondary_id>
    <nct_id>NCT02264847</nct_id>
  </id_info>
  <brief_title>Human Chorionic Gonadotrophin &amp; Trigger</brief_title>
  <official_title>Trigger or Not to Trigger? : An Answer for an Old Question</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In women being treated with medicines to help eggs to grow (called ovulation induction), The&#xD;
      investigators wish to know whether adding medicines (called ovulation triggers) that help to&#xD;
      release the egg (ovulation) would lead to more women having babies without causing harm&#xD;
      compared with not giving them ovulation triggers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women will be treated with clomiphene citrate to help eggs to develop to additionally receive&#xD;
      a medicine (urinary hCG) to trigger their release or to receive no additional treatment. the&#xD;
      investigators tried to determine the benefits and harms of administering an ovulation trigger&#xD;
      to anovulatory women receiving treatment with ovulation-inducing agents in comparison with&#xD;
      spontaneous ovulation following ovulation induction. so we will have comparison between 2&#xD;
      groups, group 1 will receive clomiphene citrate and trigger ovulation by human chorionic&#xD;
      gonadotrophin and group 2 will receive clomiphene citrate with no drug to trigger ovulation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</primary_completion_date>
  <phase>Phase 3</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ovulation rate</measure>
    <time_frame>1 year</time_frame>
    <description>Collapse of the leading follicle with irregular shape, Appearance of the corpus luteum with diffuse internal echoes. Presence of fluid in the pouch of Douglas or hyperechoic endometrium were taken as supporting features.&#xD;
Serum progesterone levels of more than 10 ng/mL were considered to be evidence of ovulation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>chemical pregnancy</measure>
    <time_frame>1 year</time_frame>
    <description>A positive urine pregnancy test done 7 days after missing the period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical pregnancy</measure>
    <time_frame>1 year</time_frame>
    <description>demonstration of a fetal heart beat on transvaginal ultrasound between 6 and 7 weeks of gestation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Ovulation Disorder</condition>
  <arm_group>
    <arm_group_label>Clomiphene citrate plus hCG</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women will receive clomiphene citrate from day 2 to day 6 of the cycle with a starting dose of 100 mg daily. If no response could be observed, the daily dose of clomiphene citrate in subsequent cycles will be increased by 50 mg until a response will be obtained or a maximum daily dose 200 mg of clomiphene citrate will be used. Once a follicle will reach more than 18 mm in size . Women will receive 5,000 IU human chorionic gonadotrophin trigger in the morning between 9 and 10 a.m. and the couple will be advised to have intercourse the following night, about 36 hours later.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clomiphene Citrate alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women will receive clomiphene citrate from day 2 to day 6 of the cycle with a starting dose of 100 mg daily. If no response will be observed, the daily dose of clomiphene citrate in subsequent cycles will be increased by 50 mg until a response will be obtained or a maximum daily dose 200 mg of clomiphene citrate will be used. Once a follicle will reach more than 18 mm in size , the women will be advised to have intercourse frequently over the next few days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Human chorionic gonadotrophin</intervention_name>
    <description>Once a follicle reached more than 18 mm in size,women assigned to group (1) received 5,000 IU hCG trigger in the morning between 9 and 10 a.m. and the couple were advised to have intercourse the following night, about 36 hours later.</description>
    <arm_group_label>Clomiphene citrate plus hCG</arm_group_label>
    <other_name>hCG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>clomiphene citrate alone</intervention_name>
    <description>clomiphene citrate alone without hCG trigger</description>
    <arm_group_label>Clomiphene Citrate alone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Normoprolactinemic and normogonadotropic (WHO class II ovarian dysfunction )&#xD;
&#xD;
          2. Primary infertility with oligomenorrhea (bleeding intervals between 35 days and 6&#xD;
             months) or amenorrhea (bleeding interval more than 6 months)&#xD;
&#xD;
          3. Age 18-40 years&#xD;
&#xD;
          4. Duration of primary infertility more than2 years&#xD;
&#xD;
          5. No history of ovulation induction treatment&#xD;
&#xD;
          6. No history of thyroid disease&#xD;
&#xD;
          7. Normal results on hysterosalpingogram&#xD;
&#xD;
          8. Husband with normal semen analysis&#xD;
&#xD;
             -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Ovarian cyst&#xD;
&#xD;
          2. Endometrioma&#xD;
&#xD;
          3. Liver disease&#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>Waleed El-khyatat, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Waleed EL-khayat, M.D.</last_name>
    <phone>01005135542</phone>
    <phone_ext>+2</phone_ext>
    <email>waleed_elkhyat@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>faculty of medicine , Cairo University</name>
      <address>
        <city>Cairo</city>
        <zip>12311</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Waleed M El-khayat, M.D.</last_name>
      <phone>0105135542</phone>
      <phone_ext>+2</phone_ext>
      <email>waleed_elkhyat@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Waleed El-khayat, M.D.</last_name>
      <phone>01005135542</phone>
      <phone_ext>+2</phone_ext>
      <email>waleed_elkhyat@yahoo.com</email>
    </contact_backup>
    <investigator>
      <last_name>Waleed M El-Khayat, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>George K, Kamath MS, Nair R, Tharyan P. Ovulation triggers in anovulatory women undergoing ovulation induction. Cochrane Database Syst Rev. 2014 Jan 31;(1):CD006900. doi: 10.1002/14651858.CD006900.pub3.</citation>
    <PMID>24482059</PMID>
  </reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>October 4, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>February 7, 2017</last_update_submitted>
  <last_update_submitted_qc>February 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Waleed El-khayat</investigator_full_name>
    <investigator_title>Assistant Professor of Obstetrics &amp; Gynecology</investigator_title>
  </responsible_party>
  <keyword>Clomiphene Citrate</keyword>
  <keyword>Ovulation trigger</keyword>
  <keyword>Human chorionic gonadotrophin</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clomiphene</mesh_term>
    <mesh_term>Enclomiphene</mesh_term>
    <mesh_term>Zuclomiphene</mesh_term>
    <mesh_term>Chorionic Gonadotropin</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/NCT02264847
org study id: 5102014
secondary id: A5102014
nct id: NCT02264847
lead sponsor: 
has dmc: Yes
In women being treated with medicines to help eggs to grow (called ovulation induction), The
      investigators wish to know whether adding medicines (called ovulation triggers) that help to
      release the egg (ovulation) would lead to more women having babies without causing harm
      compared with not giving them ovulation triggers.
Women will be treated with clomiphene citrate to help eggs to develop to additionally receive
      a medicine (urinary hCG) to trigger their release or to receive no additional treatment. the
      investigators tried to determine the benefits and harms of administering an ovulation trigger
      to anovulatory women receiving treatment with ovulation-inducing agents in comparison with
      spontaneous ovulation following ovulation induction. so we will have comparison between 2
      groups, group 1 will receive clomiphene citrate and trigger ovulation by human chorionic
      gonadotrophin and group 2 will receive clomiphene citrate with no drug to trigger ovulation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Ovulation rate
time frame: 1 year
description: Collapse of the leading follicle with irregular shape, Appearance of the corpus luteum with diffuse internal echoes. Presence of fluid in the pouch of Douglas or hyperechoic endometrium were taken as supporting features.
Serum progesterone levels of more than 10 ng/mL were considered to be evidence of ovulation.
measure: chemical pregnancy
time frame: 1 year
description: A positive urine pregnancy test done 7 days after missing the period
measure: Clinical pregnancy
time frame: 1 year
description: demonstration of a fetal heart beat on transvaginal ultrasound between 6 and 7 weeks of gestation.
arm group label: Clomiphene citrate plus hCG
arm group type: Active Comparator
description: Women will receive clomiphene citrate from day 2 to day 6 of the cycle with a starting dose of 100 mg daily. If no response could be observed, the daily dose of clomiphene citrate in subsequent cycles will be increased by 50 mg until a response will be obtained or a maximum daily dose 200 mg of clomiphene citrate will be used. Once a follicle will reach more than 18 mm in size . Women will receive 5,000 IU human chorionic gonadotrophin trigger in the morning between 9 and 10 a.m. and the couple will be advised to have intercourse the following night, about 36 hours later.
arm group label: Clomiphene Citrate alone
arm group type: Active Comparator
description: Women will receive clomiphene citrate from day 2 to day 6 of the cycle with a starting dose of 100 mg daily. If no response will be observed, the daily dose of clomiphene citrate in subsequent cycles will be increased by 50 mg until a response will be obtained or a maximum daily dose 200 mg of clomiphene citrate will be used. Once a follicle will reach more than 18 mm in size , the women will be advised to have intercourse frequently over the next few days.
intervention type: Drug
intervention name: Human chorionic gonadotrophin
description: Once a follicle reached more than 18 mm in size,women assigned to group (1) received 5,000 IU hCG trigger in the morning between 9 and 10 a.m. and the couple were advised to have intercourse the following night, about 36 hours later.
arm group label: Clomiphene citrate plus hCG
other name: hCG
intervention type: Drug
intervention name: clomiphene citrate alone
description: clomiphene citrate alone without hCG trigger
arm group label: Clomiphene Citrate alone
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Waleed El-khyatat, M.D.
role: Principal Investigator
affiliation: Cairo University
last name: Waleed EL-khayat, M.D.
phone: 01005135542
phone ext: +2
email: waleed_elkhyat@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Egypt
citation: George K, Kamath MS, Nair R, Tharyan P. Ovulation triggers in anovulatory women undergoing ovulation induction. Cochrane Database Syst Rev. 2014 Jan 31;(1):CD006900. doi: 10.1002/14651858.CD006900.pub3.
PMID: 24482059
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Waleed El-khayat
investigator title: Assistant Professor of Obstetrics & Gynecology
mesh term: Clomiphene
mesh term: Enclomiphene
mesh term: Zuclomiphene
mesh term: Chorionic Gonadotropin