<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/NCT03018314</url>
  </required_header>
  <id_info>
    <org_study_id>2016/165</org_study_id>
    <nct_id>NCT03018314</nct_id>
  </id_info>
  <brief_title>Serum Kisspeptin Levels in Infertile Women</brief_title>
  <official_title>Serum Kisspeptin Levels in Infertile Women Due to Anovulatory Cycles, Unexplained Infertility or Male Subfertility: A Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study population is comprise of 90 women those age varies between 18-38 year-old. The&#xD;
      first group will comprise of 30 women with polycystic ovaries or anovulatory cycles, the&#xD;
      second group will comprise of 30 women with diagnosis of unexplained infertility and the&#xD;
      third group will comprise of 30 women those partners with male subfertility. A 2 cc blood&#xD;
      sample for Kisspeptin analysis will be drawn from the antecubital vein from each&#xD;
      participants. The patients will receive 50 mg clomiphene citrate at the fifth day of the&#xD;
      menstrual period and follicular development will be measured with serial ultrasound follow&#xD;
      up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study population is comprise of 90 women those age varies between 18-38 year-old with&#xD;
      wish of baby for at least one year despite of unprotected sexual intercourse, patent tubes&#xD;
      confirmed in hysterosalpingography , follicle stimulating hormone levels &lt;12 IU. The first&#xD;
      group will comprise of 30 women with polycystic ovaries in ultrasound examination or&#xD;
      anovulatory cycles, the second group will comprise of 30 women with diagnosis of unexplained&#xD;
      infertility, normal menstrual periods and without known male factor infertility and the third&#xD;
      group will comprise of 30 women those partners with sperm count between 5x106 -15x106 /mL,&#xD;
      type A + type B motility &lt;%32 and Kruger morphology &lt;4%. A 2 cc blood sample for Kisspeptin&#xD;
      analysis will be drawn from the antecubital vein from each participants and centrifuged and&#xD;
      sera will be kept in -80 C till recruitment has been completed. Kisspeptin, E2, Progesterone,&#xD;
      anti-mullerian hormone levels will be measured with ELISA method. The patients will receive&#xD;
      50 mg clomiphene citrate at the fifth day of the menstrual period and follicular development&#xD;
      will be measured with serial ultrasound follow up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The relation of Kisspeptin levels and female infertility</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The relation of Kisspeptin levels and follicular growth</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Infertility, Female</condition>
  <condition>Unexplained Infertility</condition>
  <condition>Anovulation</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>The first group will comprise of 30 women with polycystic ovaries in ultrasound examination or anovulatory cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <description>The second group will comprise of 30 women with diagnosis of unexplained infertility, normal menstrual periods and without known male factor infertility.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <description>The third group will comprise of 30 women those partners with sperm count between 5x106 -15x106 /mL, type A + type B motility &lt;%32 and Kruger morphology &lt;4%.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>Serum analysis</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
    <other_name>Serum Kisspeptin levels</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        90 infertile female women those with infertile couples due to anovulation,male sub&#xD;
        fertility and unexplained infertility.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ages varying between 18-38 year-old with wish of baby for at least one year despite of&#xD;
             unprotected sexual intercourse&#xD;
&#xD;
          -  patent tubes confirmed in hysterosalpingography&#xD;
&#xD;
          -  follicle stimulating hormone levels &lt;12 IU&#xD;
&#xD;
          -  no other relevant medical history&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ages other than 18-38 year-old with wish of baby for least than one year despite of&#xD;
             unprotected sexual intercourse&#xD;
&#xD;
          -  obstructed tubes confirmed in hysterosalpingography&#xD;
&#xD;
          -  follicle stimulating hormone levels &gt;12 IU&#xD;
&#xD;
          -  history thyroid disease&#xD;
&#xD;
          -  increased prolactin levels&#xD;
&#xD;
          -  history of chemo/radiation therapy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cihan Kaya, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bakırkoy Dr. Sadi Konuk Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bakirkoy Dr Sadi Konuk Teaching and Research Hospital, Department of Obstetrics and Gynecology</name>
      <address>
        <city>Istanbul</city>
        <zip>34250</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/?term=The+kisspeptin-GnRH+pathway+in+human+reproductive+health+and+disease</url>
    <description>PUBMED</description>
  </link>
  <reference>
    <citation>Skorupskaite K, George JT, Anderson RA. The kisspeptin-GnRH pathway in human reproductive health and disease. Hum Reprod Update. 2014 Jul-Aug;20(4):485-500. doi: 10.1093/humupd/dmu009. Epub 2014 Mar 9.</citation>
    <PMID>24615662</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</mesh_term>
    <mesh_term>Anovulation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>After study completed</ipd_description>
  </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/NCT03018314
org study id: 2016/165
nct id: NCT03018314
lead sponsor: 
has dmc: No
The study population is comprise of 90 women those age varies between 18-38 year-old. The
      first group will comprise of 30 women with polycystic ovaries or anovulatory cycles, the
      second group will comprise of 30 women with diagnosis of unexplained infertility and the
      third group will comprise of 30 women those partners with male subfertility. A 2 cc blood
      sample for Kisspeptin analysis will be drawn from the antecubital vein from each
      participants. The patients will receive 50 mg clomiphene citrate at the fifth day of the
      menstrual period and follicular development will be measured with serial ultrasound follow
      up.
The study population is comprise of 90 women those age varies between 18-38 year-old with
      wish of baby for at least one year despite of unprotected sexual intercourse, patent tubes
      confirmed in hysterosalpingography , follicle stimulating hormone levels <12 IU. The first
      group will comprise of 30 women with polycystic ovaries in ultrasound examination or
      anovulatory cycles, the second group will comprise of 30 women with diagnosis of unexplained
      infertility, normal menstrual periods and without known male factor infertility and the third
      group will comprise of 30 women those partners with sperm count between 5x106 -15x106 /mL,
      type A + type B motility <%32 and Kruger morphology <4%. A 2 cc blood sample for Kisspeptin
      analysis will be drawn from the antecubital vein from each participants and centrifuged and
      sera will be kept in -80 C till recruitment has been completed. Kisspeptin, E2, Progesterone,
      anti-mullerian hormone levels will be measured with ELISA method. The patients will receive
      50 mg clomiphene citrate at the fifth day of the menstrual period and follicular development
      will be measured with serial ultrasound follow up.
observational model: Cohort
time perspective: Prospective
measure: The relation of Kisspeptin levels and female infertility
time frame: 1 year
measure: The relation of Kisspeptin levels and follicular growth
time frame: 1 year
arm group label: Group 1
description: The first group will comprise of 30 women with polycystic ovaries in ultrasound examination or anovulatory cycles.
arm group label: Group 2
description: The second group will comprise of 30 women with diagnosis of unexplained infertility, normal menstrual periods and without known male factor infertility.
arm group label: Group 3
description: The third group will comprise of 30 women those partners with sperm count between 5x106 -15x106 /mL, type A + type B motility <%32 and Kruger morphology <4%.
intervention type: Other
intervention name: Blood sample
description: Serum analysis
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
other name: Serum Kisspeptin levels
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 38 Years
healthy volunteers: No
last name: Cihan Kaya, M.D.
role: Principal Investigator
affiliation: Bakırkoy Dr. Sadi Konuk Training and Research Hospital
facility: 
country: Turkey
url: https://www.ncbi.nlm.nih.gov/pubmed/?term=The+kisspeptin-GnRH+pathway+in+human+reproductive+health+and+disease
description: PUBMED
citation: Skorupskaite K, George JT, Anderson RA. The kisspeptin-GnRH pathway in human reproductive health and disease. Hum Reprod Update. 2014 Jul-Aug;20(4):485-500. doi: 10.1093/humupd/dmu009. Epub 2014 Mar 9.
PMID: 24615662
responsible party type: Sponsor
mesh term: Infertility
mesh term: Infertility, Female
mesh term: Anovulation
sharing ipd: Yes
ipd description: After study completed