<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/NCT03009370</url>
  </required_header>
  <id_info>
    <org_study_id>KanuniSSSTRH</org_study_id>
    <nct_id>NCT03009370</nct_id>
  </id_info>
  <brief_title>The Effect of the Ovarian Reserve on the Recurrent Pregnancy Loss</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kanuni Sultan Suleyman Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kanuni Sultan Suleyman Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether ovarian reserve is related to recurrent&#xD;
      pregnancy loss&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be conducted at the gynecology and infertility department of Kanuni Sultan&#xD;
      Süleyman Training and Research Hospital from 2016 to 2017. The approval of the local&#xD;
      Institutional Review Board (KAEK/2016.22.31) was obtained in June 2016 and informed consents&#xD;
      of all subjects have been prepared. RM is defined as three or more pregnancy losses at &lt;20&#xD;
      weeks of gestation or fetal weight &lt;500 g. Women with history of RM for whom routine workup&#xD;
      for RM (chromosomal analyses of both partners; levels of prolactin and TSH; anticardiolipin&#xD;
      antibody, lupus anticoagulant, antinuclear antibody, and coagulation studies; and pelvic&#xD;
      ultrasonography) is negative are assigned to the RM group. The control group consists of&#xD;
      healthy women with no history of RM who are seeking contraception in the center's family&#xD;
      planning unit. To keep the power of the study at 80% with an alpha-level of 0.05, a sample&#xD;
      size of minumum 60 patients in each group was required.&#xD;
&#xD;
      Demographic data (age,gravidity,parity,pregnancy loss,bmı) ovarian reserve&#xD;
      parameters(AMH,FSH,LH,E2,AFC) will be recorded and then two groups will be compared.&#xD;
&#xD;
      Data will be analyzed with the use of medcalc version 16.4.8 by Gökhan Yıldırım.&#xD;
      Mean,median,SD,lowest and highest frequency ,and ratio values are used at statistical&#xD;
      complementary of data .Quantitative data will be analyzed with the use of the Student t test&#xD;
      and the Mann-Whitney U test. A chisquare test will be used for analyses of qualitative data&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2016</start_date>
  <completion_date type="Anticipated">March 2017</completion_date>
  <primary_completion_date type="Anticipated">March 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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The effect of the ovarian reserve on the recurrent pregnancy loss</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Venous blood samples will be taken from the antecubital regions of all patients between 8:00 a.m and 9:00 a.m during the early follicular phase (days 2-4) of the menstrual cycle .Serum samples will be stored at -80C and assayed for FSH,LH,E2 and AMH .FSH levels are analyzed by means of an electrochemiluminescence method .The normal range for FSH is 2.5-10 U/L at the early follicular phase. Serum AMH levels will be measured with the use of a human ELİSA kit . The normal range for this assay is 0.05-1.5 ng/ml.In the same morning that the blood tests are performed , the total number of antral follicles measuring 2-10 mm in diameter are evaluated by the operator.A 7.5 -MHz transvaginal probe is used in all examinations.Data will be analyzed with the use of medcalc.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ovarian reserve tests can be used for the diagnosis of the cause of recurrent pregnancy loss</measure>
    <time_frame>up to 6 months</time_frame>
    <description>FSH,LH,E2,AMH assesment of at least 86 patients will be analyzed with the use of medcalc . Unıts of measure of FSH,LH,E2 levels are assesed by U/L. The normal range of AMH level is 0.05-1.5ng/ml. Mean ,median ,SD, lowest and highest frequency ,and ratio values are used at statistical complemantary data.Quantitative data are analyzed with the use of the student -t test and Mann-Whitney U test</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">86</enrollment>
  <condition>Ovarian Reserve</condition>
  <condition>Miscarriage, Recurrent</condition>
  <arm_group>
    <arm_group_label>Recurrent miscarriage</arm_group_label>
    <description>RM is defined as three or more pregnancy losses at&lt; 20 weeks of gestation.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Recurrent miscarriage is defined as three or more pregnancy loss at&lt;20 weeks of&#xD;
        gestation.The women between 20 -40 years old with history of RM are recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with RM between 20-40 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anovulation or PCOS&#xD;
&#xD;
          -  Presence of endometrosis by laparoscopy or ultrasonography&#xD;
&#xD;
          -  History of ovarian surgery&#xD;
&#xD;
          -  Tobacco use&#xD;
&#xD;
          -  Systemic chemotherapy&#xD;
&#xD;
          -  Pelvic irradition&#xD;
&#xD;
          -  Genetic abnormalities&#xD;
&#xD;
          -  Irregular menstruel cycle&#xD;
&#xD;
          -  family history of premature ovarian failure&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gonca Yetkin Yıdırım, MD</last_name>
    <role>Study Director</role>
    <affiliation>Saglik Bilimleri Universitesi</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gonca Yetkin Yıldırım, MD</last_name>
    <phone>+90 5323532205</phone>
    <email>goncayetkinyildirim@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nadiye Köroğlu, MD</last_name>
    <phone>+90 5058065348</phone>
    <email>nadiye_dugan@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi</name>
      <address>
        <city>Istanbul</city>
        <zip>34325</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Atasever M, Soyman Z, Demirel E, Gencdal S, Kelekci S. Diminished ovarian reserve: is it a neglected cause in the assessment of recurrent miscarriage? A cohort study. Fertil Steril. 2016 May;105(5):1236-1240. doi: 10.1016/j.fertnstert.2016.01.001. Epub 2016 Jan 21.</citation>
    <PMID>26806685</PMID>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 31, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 4, 2017</study_first_posted>
  <last_update_submitted>December 31, 2016</last_update_submitted>
  <last_update_submitted_qc>December 31, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kanuni Sultan Suleyman Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Gonca Yetkin Yildirim</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Ovarian reserve, pregnancy loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abortion, Spontaneous</mesh_term>
    <mesh_term>Abortion, Habitual</mesh_term>
  </condition_browse>
  <study_docs>
    <study_doc>
      <doc_type>Study Protocol</doc_type>
      <doc_url>http://www.ncbi.nlm.nih.gov/pubmed/26806685</doc_url>
    </study_doc>
  </study_docs>
  <!-- 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/NCT03009370
org study id: KanuniSSSTRH
nct id: NCT03009370
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether ovarian reserve is related to recurrent
      pregnancy loss
This study will be conducted at the gynecology and infertility department of Kanuni Sultan
      Süleyman Training and Research Hospital from 2016 to 2017. The approval of the local
      Institutional Review Board (KAEK/2016.22.31) was obtained in June 2016 and informed consents
      of all subjects have been prepared. RM is defined as three or more pregnancy losses at <20
      weeks of gestation or fetal weight <500 g. Women with history of RM for whom routine workup
      for RM (chromosomal analyses of both partners; levels of prolactin and TSH; anticardiolipin
      antibody, lupus anticoagulant, antinuclear antibody, and coagulation studies; and pelvic
      ultrasonography) is negative are assigned to the RM group. The control group consists of
      healthy women with no history of RM who are seeking contraception in the center's family
      planning unit. To keep the power of the study at 80% with an alpha-level of 0.05, a sample
      size of minumum 60 patients in each group was required.

      Demographic data (age,gravidity,parity,pregnancy loss,bmı) ovarian reserve
      parameters(AMH,FSH,LH,E2,AFC) will be recorded and then two groups will be compared.

      Data will be analyzed with the use of medcalc version 16.4.8 by Gökhan Yıldırım.
      Mean,median,SD,lowest and highest frequency ,and ratio values are used at statistical
      complementary of data .Quantitative data will be analyzed with the use of the Student t test
      and the Mann-Whitney U test. A chisquare test will be used for analyses of qualitative data
observational model: Cohort
time perspective: Cross-Sectional
measure: The effect of the ovarian reserve on the recurrent pregnancy loss
time frame: up to 6 months
description: Venous blood samples will be taken from the antecubital regions of all patients between 8:00 a.m and 9:00 a.m during the early follicular phase (days 2-4) of the menstrual cycle .Serum samples will be stored at -80C and assayed for FSH,LH,E2 and AMH .FSH levels are analyzed by means of an electrochemiluminescence method .The normal range for FSH is 2.5-10 U/L at the early follicular phase. Serum AMH levels will be measured with the use of a human ELİSA kit . The normal range for this assay is 0.05-1.5 ng/ml.In the same morning that the blood tests are performed , the total number of antral follicles measuring 2-10 mm in diameter are evaluated by the operator.A 7.5 -MHz transvaginal probe is used in all examinations.Data will be analyzed with the use of medcalc.
measure: Ovarian reserve tests can be used for the diagnosis of the cause of recurrent pregnancy loss
time frame: up to 6 months
description: FSH,LH,E2,AMH assesment of at least 86 patients will be analyzed with the use of medcalc . Unıts of measure of FSH,LH,E2 levels are assesed by U/L. The normal range of AMH level is 0.05-1.5ng/ml. Mean ,median ,SD, lowest and highest frequency ,and ratio values are used at statistical complemantary data.Quantitative data are analyzed with the use of the student -t test and Mann-Whitney U test
arm group label: Recurrent miscarriage
description: RM is defined as three or more pregnancy losses at< 20 weeks of gestation.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gonca Yetkin Yıdırım, MD
role: Study Director
affiliation: Saglik Bilimleri Universitesi
last name: Gonca Yetkin Yıldırım, MD
phone: +90 5323532205
email: goncayetkinyildirim@gmail.com
last name: Nadiye Köroğlu, MD
phone: +90 5058065348
email: nadiye_dugan@hotmail.com
facility: 
status: Recruiting
country: Turkey
citation: Atasever M, Soyman Z, Demirel E, Gencdal S, Kelekci S. Diminished ovarian reserve: is it a neglected cause in the assessment of recurrent miscarriage? A cohort study. Fertil Steril. 2016 May;105(5):1236-1240. doi: 10.1016/j.fertnstert.2016.01.001. Epub 2016 Jan 21.
PMID: 26806685
responsible party type: Principal Investigator
investigator affiliation: Kanuni Sultan Suleyman Training and Research Hospital
investigator full name: Gonca Yetkin Yildirim
investigator title: MD
mesh term: Abortion, Spontaneous
mesh term: Abortion, Habitual
study doc: 