<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/NCT01718444</url>
  </required_header>
  <id_info>
    <org_study_id>2014-1070</org_study_id>
    <nct_id>NCT01718444</nct_id>
  </id_info>
  <brief_title>Progestin-induced Endometrial Shedding in PCOS (The PIES in PCOS Study)</brief_title>
  <official_title>Optimizing Fertility Treatment in Women With Polycystic Ovary Syndrome (PCOS) - A Randomized Controlled Trial: The Role of Progestin-induced Endometrial Shedding in PCOS (PIES in PCOS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Illinois at Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Illinois at Chicago</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Progestin-induced endometrial shedding (PIES) followed by clomiphene citrate is fertility&#xD;
      treatment of choice in anovulatory women with polycystic ovary syndrome (PCOS). However, some&#xD;
      preliminary data suggest that skipping PIES could result in a higher live birth rate. The&#xD;
      investigators are performing the first randomized controlled trial to find out if skipping&#xD;
      the use of progestin during fertility treatment of anovulatory PCOS women is associated with&#xD;
      improved pregnancy and live birth rates compared to the traditional approach of using&#xD;
      progestin prior to use of clomiphene citrate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective randomized trial of clomiphene citrate (CC) preceded by&#xD;
      progestin-induced endometrial shedding (PIES) vs CC without PIES in the treatment of&#xD;
      infertility in patients with PCOS, for up to 5 treatment cycles.&#xD;
&#xD;
      Participants will be randomized to receive either progestin followed by CC starting on day 3&#xD;
      of the induced menses, or CC without induced menses. Study participants will be monitored at&#xD;
      regular 2 to 4 wks intervals for response to medication using ultrasound and hormonal&#xD;
      parameters. The maximum dose of CC will not exceed 750 mg/cycle. Treatment will not exceed 5&#xD;
      ovulatory cycles. Participants who are resistant to 150 mg of CC will exit the study.&#xD;
&#xD;
      170 anovulatory PCOS women actively seeking pregnancy, aged 18 through 40 years will be&#xD;
      enrolled and randomized in a 1:1 treatment ratio into the two study arms. Anovulation will be&#xD;
      the only infertility factor in all patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The primary investigator moved from academic practice to join a private group, and could not&#xD;
    get any one to take over as PI for the study.&#xD;
  </why_stopped>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Live Birth</measure>
    <time_frame>Within 36 weeks of a positive pregnancy test</time_frame>
    <description>Delivery of a viable infant after 24 weeks of pregnancy</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Polycystic Ovary Syndrome</condition>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Group A (No PIES)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects randomized to this group will receive clomiphene citrate (CC) without using progestin throughout their treatment course.&#xD;
CC 50 mg oral for 5 days (&quot;Days 3-7&quot;)&#xD;
If no ovulation, CC 100 mg for 5 days (&quot;Days 12-16&quot;)&#xD;
If no ovulation, CC 150 mg for 5 days (&quot;Day 21-25&quot;)&#xD;
Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B (PIES Group)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Women randomized to this group will receive progestin to induce endometrial shedding before starting any doses of clomiphene citrate (CC)&#xD;
Progestin 10 mg oral for 10 days to induce endometrial shedding (PIES)&#xD;
CC 50 mg oral for 5 days (Day 3-7)&#xD;
If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding (starting on CD28) and CC 100 mg x 5 days, starting on day 3 of induced menses&#xD;
If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding, and CC 150 mg for 5 days&#xD;
Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Progestin</intervention_name>
    <arm_group_label>Group B (PIES Group)</arm_group_label>
    <other_name>Provera</other_name>
    <other_name>Medroxyprogesterone acetate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clomiphene Citrate</intervention_name>
    <arm_group_label>Group A (No PIES)</arm_group_label>
    <arm_group_label>Group B (PIES Group)</arm_group_label>
    <other_name>Clomid</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion&#xD;
&#xD;
          -  Women aged 18 - 40, desiring pregnancy&#xD;
&#xD;
          -  Established diagnosis of PCOS confirmed by the Rotterdam criteria&#xD;
&#xD;
          -  Oligo or anovulatory, with menstrual cycles &gt; 35 days apart or less than 9 menstrual&#xD;
             cycles per year&#xD;
&#xD;
          -  Normal vaginal ultrasound with endometrial stripe &lt; 12 mm&#xD;
&#xD;
          -  Normal thyroid stimulating hormone (TSH) within past one year&#xD;
&#xD;
          -  Normal prolactin (PRL) within past one year&#xD;
&#xD;
          -  For women with previous successful Clomid treatment, a washout period of at least 2&#xD;
             months is required&#xD;
&#xD;
        Exclusion&#xD;
&#xD;
          -  Regular menstrual cycles occurring less than 35 days apart&#xD;
&#xD;
          -  Evidence of other infertility factors such as endometriosis, tubal factor or male&#xD;
             infertility&#xD;
&#xD;
          -  Prior unsuccessful Clomiphene citrate ovulation cycles&#xD;
&#xD;
          -  Abnormal vaginal ultrasound findings such as endometrial polyps, submucous myomas,&#xD;
             synechiae&#xD;
&#xD;
          -  Uterine anomaly such as unicornuate or bicornuate uterus&#xD;
&#xD;
          -  Presence of hydrosalpinx&#xD;
&#xD;
          -  Evidence of active endocrinopathy, such as thyroid disorder or hyperprolactinemia&#xD;
&#xD;
          -  Partner with abnormal semen analysis (count &lt; 15 million sperm /ml)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Albert Asante, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Illinois at Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Illinois at Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <results_first_submitted>September 8, 2020</results_first_submitted>
  <results_first_submitted_qc>September 8, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 29, 2020</results_first_posted>
  <last_update_submitted>September 8, 2020</last_update_submitted>
  <last_update_submitted_qc>September 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Illinois at Chicago</investigator_affiliation>
    <investigator_full_name>Albert Asante, MD MPH</investigator_full_name>
    <investigator_title>Assistant Professor of Obstetrics-Gynecology, Consultant in Reproductive Endocrinology and Infertility</investigator_title>
  </responsible_party>
  <keyword>PCOS</keyword>
  <keyword>Polycystic ovary syndrome</keyword>
  <keyword>Infertility</keyword>
  <keyword>Anovulation</keyword>
  <keyword>Clomiphene citrate</keyword>
  <keyword>Clomid</keyword>
  <keyword>Progestin</keyword>
  <keyword>Provera</keyword>
  <keyword>Progesterone</keyword>
  <keyword>Endometrial shedding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polycystic Ovary Syndrome</mesh_term>
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Medroxyprogesterone Acetate</mesh_term>
    <mesh_term>Clomiphene</mesh_term>
    <mesh_term>Enclomiphene</mesh_term>
    <mesh_term>Zuclomiphene</mesh_term>
    <mesh_term>Medroxyprogesterone</mesh_term>
    <mesh_term>Progestins</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The study was terminated and data cannot be retrieved as the software where data has been stored has been upgraded. We have exhausted efforts to retrieve the data from this software and no study data are available.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group A (No PIES)</title>
          <description>Subjects randomized to this group will receive clomiphene citrate (CC) without using progestin throughout their treatment course.&#xD;
CC 50 mg oral for 5 days (&quot;Days 3-7&quot;)&#xD;
If no ovulation, CC 100 mg for 5 days (&quot;Days 12-16&quot;)&#xD;
If no ovulation, CC 150 mg for 5 days (&quot;Day 21-25&quot;)&#xD;
Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles&#xD;
Clomiphene Citrate</description>
        </group>
        <group group_id="P2">
          <title>Group B (PIES Group)</title>
          <description>Women randomized to this group will receive progestin to induce endometrial shedding before starting any doses of clomiphene citrate (CC)&#xD;
Progestin 10 mg oral for 10 days to induce endometrial shedding (PIES)&#xD;
CC 50 mg oral for 5 days (Day 3-7)&#xD;
If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding (starting on CD28) and CC 100 mg x 5 days, starting on day 3 of induced menses&#xD;
If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding, and CC 150 mg for 5 days&#xD;
Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles&#xD;
Progestin&#xD;
Clomiphene Citrate</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The study was terminated and data cannot be retrieved as the software where data has been stored has been upgraded. We have exhausted efforts to retrieve the data from this software and no study data are available.</population>
      <group_list>
        <group group_id="B1">
          <title>Group A (No PIES)</title>
          <description>Subjects randomized to this group will receive clomiphene citrate (CC) without using progestin throughout their treatment course.&#xD;
CC 50 mg oral for 5 days (&quot;Days 3-7&quot;)&#xD;
If no ovulation, CC 100 mg for 5 days (&quot;Days 12-16&quot;)&#xD;
If no ovulation, CC 150 mg for 5 days (&quot;Day 21-25&quot;)&#xD;
Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles&#xD;
Clomiphene Citrate</description>
        </group>
        <group group_id="B2">
          <title>Group B (PIES Group)</title>
          <description>Women randomized to this group will receive progestin to induce endometrial shedding before starting any doses of clomiphene citrate (CC)&#xD;
Progestin 10 mg oral for 10 days to induce endometrial shedding (PIES)&#xD;
CC 50 mg oral for 5 days (Day 3-7)&#xD;
If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding (starting on CD28) and CC 100 mg x 5 days, starting on day 3 of induced menses&#xD;
If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding, and CC 150 mg for 5 days&#xD;
Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles&#xD;
Progestin&#xD;
Clomiphene Citrate</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="0"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>The study was terminated and data cannot be retrieved as the software where data has been stored has been upgraded. We have exhausted efforts to retrieve the data from this software and no study data are available.</population>
          <units>years</units>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>The study was terminated and data cannot be retrieved as the software where data has been stored has been upgraded. We have exhausted efforts to retrieve the data from this software and no study data are available</population>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Live Birth</title>
        <description>Delivery of a viable infant after 24 weeks of pregnancy</description>
        <time_frame>Within 36 weeks of a positive pregnancy test</time_frame>
        <population>The study was terminated and data cannot be retrieved as the software where data has been stored has been upgraded. We have exhausted efforts to retrieve the data from this software and no study data are available.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A (No PIES)</title>
            <description>Subjects randomized to this group will receive clomiphene citrate (CC) without using progestin throughout their treatment course.&#xD;
CC 50 mg oral for 5 days (&quot;Days 3-7&quot;)&#xD;
If no ovulation, CC 100 mg for 5 days (&quot;Days 12-16&quot;)&#xD;
If no ovulation, CC 150 mg for 5 days (&quot;Day 21-25&quot;)&#xD;
Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles&#xD;
Clomiphene Citrate</description>
          </group>
          <group group_id="O2">
            <title>Group B (PIES Group)</title>
            <description>Women randomized to this group will receive progestin to induce endometrial shedding before starting any doses of clomiphene citrate (CC)&#xD;
Progestin 10 mg oral for 10 days to induce endometrial shedding (PIES)&#xD;
CC 50 mg oral for 5 days (Day 3-7)&#xD;
If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding (starting on CD28) and CC 100 mg x 5 days, starting on day 3 of induced menses&#xD;
If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding, and CC 150 mg for 5 days&#xD;
Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles&#xD;
Progestin&#xD;
Clomiphene Citrate</description>
          </group>
        </group_list>
        <measure>
          <title>Live Birth</title>
          <description>Delivery of a viable infant after 24 weeks of pregnancy</description>
          <population>The study was terminated and data cannot be retrieved as the software where data has been stored has been upgraded. We have exhausted efforts to retrieve the data from this software and no study data are available.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>The study was terminated and data cannot be retrieved as the software where data has been stored has been upgraded. We have exhausted efforts to retrieve the data from this software and no study data are available.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group A (No PIES)</title>
          <description>Subjects randomized to this group will receive clomiphene citrate (CC) without using progestin throughout their treatment course.&#xD;
CC 50 mg oral for 5 days (&quot;Days 3-7&quot;)&#xD;
If no ovulation, CC 100 mg for 5 days (&quot;Days 12-16&quot;)&#xD;
If no ovulation, CC 150 mg for 5 days (&quot;Day 21-25&quot;)&#xD;
Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles&#xD;
Clomiphene Citrate</description>
        </group>
        <group group_id="E2">
          <title>Group B (PIES Group)</title>
          <description>Women randomized to this group will receive progestin to induce endometrial shedding before starting any doses of clomiphene citrate (CC)&#xD;
Progestin 10 mg oral for 10 days to induce endometrial shedding (PIES)&#xD;
CC 50 mg oral for 5 days (Day 3-7)&#xD;
If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding (starting on CD28) and CC 100 mg x 5 days, starting on day 3 of induced menses&#xD;
If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding, and CC 150 mg for 5 days&#xD;
Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles&#xD;
Progestin&#xD;
Clomiphene Citrate</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study was terminated and data cannot be retrieved as the software where data has been stored has been upgraded. We have exhausted efforts to retrieve the data from this software and no study data are available.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Albert Asante, MD MPH</name_or_title>
      <organization>UIC</organization>
      <phone>3123552634</phone>
      <email>akdasante@yahoo.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01718444
org study id: 2014-1070
nct id: NCT01718444
lead sponsor: 
has dmc: No
Progestin-induced endometrial shedding (PIES) followed by clomiphene citrate is fertility
      treatment of choice in anovulatory women with polycystic ovary syndrome (PCOS). However, some
      preliminary data suggest that skipping PIES could result in a higher live birth rate. The
      investigators are performing the first randomized controlled trial to find out if skipping
      the use of progestin during fertility treatment of anovulatory PCOS women is associated with
      improved pregnancy and live birth rates compared to the traditional approach of using
      progestin prior to use of clomiphene citrate.
This is a prospective randomized trial of clomiphene citrate (CC) preceded by
      progestin-induced endometrial shedding (PIES) vs CC without PIES in the treatment of
      infertility in patients with PCOS, for up to 5 treatment cycles.

      Participants will be randomized to receive either progestin followed by CC starting on day 3
      of the induced menses, or CC without induced menses. Study participants will be monitored at
      regular 2 to 4 wks intervals for response to medication using ultrasound and hormonal
      parameters. The maximum dose of CC will not exceed 750 mg/cycle. Treatment will not exceed 5
      ovulatory cycles. Participants who are resistant to 150 mg of CC will exit the study.

      170 anovulatory PCOS women actively seeking pregnancy, aged 18 through 40 years will be
      enrolled and randomized in a 1:1 treatment ratio into the two study arms. Anovulation will be
      the only infertility factor in all patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Live Birth
time frame: Within 36 weeks of a positive pregnancy test
description: Delivery of a viable infant after 24 weeks of pregnancy
arm group label: Group A (No PIES)
arm group type: Experimental
description: Subjects randomized to this group will receive clomiphene citrate (CC) without using progestin throughout their treatment course.
CC 50 mg oral for 5 days ("Days 3-7")
If no ovulation, CC 100 mg for 5 days ("Days 12-16")
If no ovulation, CC 150 mg for 5 days ("Day 21-25")
Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles
arm group label: Group B (PIES Group)
arm group type: Active Comparator
description: Women randomized to this group will receive progestin to induce endometrial shedding before starting any doses of clomiphene citrate (CC)
Progestin 10 mg oral for 10 days to induce endometrial shedding (PIES)
CC 50 mg oral for 5 days (Day 3-7)
If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding (starting on CD28) and CC 100 mg x 5 days, starting on day 3 of induced menses
If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding, and CC 150 mg for 5 days
Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles
intervention type: Drug
intervention name: Progestin
arm group label: Group B (PIES Group)
other name: Provera
other name: Medroxyprogesterone acetate
intervention type: Drug
intervention name: Clomiphene Citrate
arm group label: Group A (No PIES)
arm group label: Group B (PIES Group)
other name: Clomid
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Albert Asante, MD, MPH
role: Principal Investigator
affiliation: University of Illinois at Chicago
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Illinois at Chicago
investigator full name: Albert Asante, MD MPH
investigator title: Assistant Professor of Obstetrics-Gynecology, Consultant in Reproductive Endocrinology and Infertility
mesh term: Polycystic Ovary Syndrome
mesh term: Infertility
mesh term: Syndrome
mesh term: Medroxyprogesterone Acetate
mesh term: Clomiphene
mesh term: Enclomiphene
mesh term: Zuclomiphene
mesh term: Medroxyprogesterone
mesh term: Progestins
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study was terminated and data cannot be retrieved as the software where data has been stored has been upgraded. We have exhausted efforts to retrieve the data from this software and no study data are available.
point of contact: 