<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/NCT03806036</url>
  </required_header>
  <id_info>
    <org_study_id>47</org_study_id>
    <nct_id>NCT03806036</nct_id>
  </id_info>
  <brief_title>The Effect Of Vitamin D Replacement Therapy On Serum Leptin And Follicular Growth Pattern In Women With Resistant Polycystic Ovary</brief_title>
  <official_title>The Effect Of Vitamin D Replacement Therapy On Serum Leptin And Follicular Growth Pattern In Women With Resistant Polycystic Ovarian Syndrome</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study included 100 female diagnosed with polycystic ovary syndrome. They were classified&#xD;
      into 2 groups: Study group included 50 women will receive 300.000 I.U single dose of Vitamin&#xD;
      D intramuscular injection (Memphis company) , and in the next menstrual cycle induction done&#xD;
      by clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG&#xD;
      single dose on 8th day . Control group included 50 women will receive only clomiphen citrate&#xD;
      100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th&#xD;
      day. Serum 25 hydroxy Vitamin D3, Serum Leptin and FSH will be done to all women before and&#xD;
      after intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study included 100 female diagnosed with polycystic ovary syndrome diagnosed by by&#xD;
      presence of 2 out of 3 criteria (according to ESHRE/ASRM in Rotterdam in 2003):&#xD;
      oligoovulation and/or an ovulation , excess androgen activity (clinical or biochemical) and&#xD;
      polycystic ovaries (by pelvic ultrasound &quot;vaginal route&quot;).They were classified into 2 groups:&#xD;
      Study group included 50 women will receive 300.000 I.U single dose of Vitamin D intramuscular&#xD;
      injection (Memphis company) , and in the next menstrual cycle induction done by clomiphen&#xD;
      citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on&#xD;
      8th day . Control group included 50 women will receive only clomiphen citrate 100mg daily for&#xD;
      5 days starting from third day of menstruation and HMG single dose on 8th day. Serum 25&#xD;
      hydroxy Vitamin D3, Serum Leptin and FSH will be done to all women before and after&#xD;
      intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2, 2018</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">February 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ovulation</measure>
    <time_frame>14 days after menses</time_frame>
    <description>appearance of dominant follicle 18 - 22 mm in diameter</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Polycystic Ovary Syndrome</condition>
  <arm_group>
    <arm_group_label>Vitamin D group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50 women will receive 300.000 I.U single dose of VIT D IM injection (Memphis company) , and in the next menstrual cycle induction done by clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>50 women will receive clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin D</intervention_name>
    <description>300.000 I.U single dose of VIT D IM injection</description>
    <arm_group_label>Vitamin D group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clomiphene Citrate</intervention_name>
    <description>100mg daily for 5 days starting from third day of menstruation</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Vitamin D group</arm_group_label>
    <other_name>Clomid</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1- BMI: more than 25.0 kg/m2&#xD;
&#xD;
        2- PCO was diagnosed by presence of 2 out of 3 criteria (according to ESHRE/ASRM in&#xD;
        Rotterdam in 2003)&#xD;
&#xD;
          1. oligoovulation and/or an ovulation&#xD;
&#xD;
          2. excess androgen activity (clinical or biochemical)&#xD;
&#xD;
          3. polycystic ovaries (by pelvic ultrasound &quot;vaginal route&quot;)&#xD;
&#xD;
        3- Anovulatory patient resistant to induction with clomiphene citrate alone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -1) BMI: more than 35.0 kg/m2&#xD;
&#xD;
        2) Infertile women due to any factor other than PCO&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Maged</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed Maged, MD</last_name>
    <phone>+201005227404</phone>
    <email>prof.ahmedmaged@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wesam Deeb, MD</last_name>
    <email>wessamdeeb74@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kasr Alainy medical school</name>
      <address>
        <city>Cairo</city>
        <zip>12151</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed Maged, MD</last_name>
      <phone>01005227404</phone>
      <email>prof.ahmedmaged@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 13, 2019</study_first_submitted>
  <study_first_submitted_qc>January 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 13, 2019</last_update_submitted>
  <last_update_submitted_qc>January 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Maged</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Clomiphene</mesh_term>
    <mesh_term>Enclomiphene</mesh_term>
    <mesh_term>Zuclomiphene</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/NCT03806036
org study id: 47
nct id: NCT03806036
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study included 100 female diagnosed with polycystic ovary syndrome. They were classified
      into 2 groups: Study group included 50 women will receive 300.000 I.U single dose of Vitamin
      D intramuscular injection (Memphis company) , and in the next menstrual cycle induction done
      by clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG
      single dose on 8th day . Control group included 50 women will receive only clomiphen citrate
      100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th
      day. Serum 25 hydroxy Vitamin D3, Serum Leptin and FSH will be done to all women before and
      after intervention.
The study included 100 female diagnosed with polycystic ovary syndrome diagnosed by by
      presence of 2 out of 3 criteria (according to ESHRE/ASRM in Rotterdam in 2003):
      oligoovulation and/or an ovulation , excess androgen activity (clinical or biochemical) and
      polycystic ovaries (by pelvic ultrasound "vaginal route").They were classified into 2 groups:
      Study group included 50 women will receive 300.000 I.U single dose of Vitamin D intramuscular
      injection (Memphis company) , and in the next menstrual cycle induction done by clomiphen
      citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on
      8th day . Control group included 50 women will receive only clomiphen citrate 100mg daily for
      5 days starting from third day of menstruation and HMG single dose on 8th day. Serum 25
      hydroxy Vitamin D3, Serum Leptin and FSH will be done to all women before and after
      intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Ovulation
time frame: 14 days after menses
description: appearance of dominant follicle 18 - 22 mm in diameter
arm group label: Vitamin D group
arm group type: Active Comparator
description: 50 women will receive 300.000 I.U single dose of VIT D IM injection (Memphis company) , and in the next menstrual cycle induction done by clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day
arm group label: Control group
arm group type: Placebo Comparator
description: 50 women will receive clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day
intervention type: Drug
intervention name: Vitamin D
description: 300.000 I.U single dose of VIT D IM injection
arm group label: Vitamin D group
intervention type: Drug
intervention name: Clomiphene Citrate
description: 100mg daily for 5 days starting from third day of menstruation
arm group label: Control group
arm group label: Vitamin D group
other name: Clomid
criteria: 
gender: Female
gender based: Yes
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: Ahmed Maged
role: Principal Investigator
affiliation: Professor
last name: Ahmed Maged, MD
phone: +201005227404
email: prof.ahmedmaged@gmail.com
last name: Wesam Deeb, MD
email: wessamdeeb74@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Maged
investigator title: Principal investigator
mesh term: Polycystic Ovary Syndrome
mesh term: Syndrome
mesh term: Vitamin D
mesh term: Clomiphene
mesh term: Enclomiphene
mesh term: Zuclomiphene