<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/NCT02202278</url>
  </required_header>
  <id_info>
    <org_study_id>139EK1</org_study_id>
    <nct_id>NCT02202278</nct_id>
  </id_info>
  <brief_title>Study of Serum Levels of Oxidative Stress Markers in Ovarian Hyperstimulation Patients</brief_title>
  <official_title>Serum Levels of IMA, TAC, TOS, OSI and MDA in Severe OHSS Patients Underwent Long Agonist Protocol Intracytoplasmic Sperm for Determining Oxidative Stress Status</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karadeniz Technical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karadeniz Technical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to determine serum oxidative stress status by ischemia modified&#xD;
      albumin (IMA), total antioxidant capacity (TAC), total oxidative capacity (TOS), oxidative&#xD;
      stress capacity (OSI), and serum malondialdehyde (MDA) in patients with OHHS and control&#xD;
      group. We also aim to reveal the association between serum levels of these factors and oocyte&#xD;
      quality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Patients included in this study were assisted reproductive technique (ART) patients with&#xD;
           moderate and severe OHSS who were hospitalized for management&#xD;
&#xD;
        -  Control patients are selected from patients without signs of OHSS&#xD;
&#xD;
        -  All patients are administered luteal long protocol for controlled ovarian stimulation.&#xD;
           Pituitary down-regulation with SC injection of GnRH agonist (GnRH-a) (1 mg/day; Lucrin,&#xD;
           Abbott Laboratories, North Chicago, IL) that was started on day 21 of the previous&#xD;
           menstrual cycle. Subcutaneous administration of recombinant hFSH (Gonal-F, Laboratories&#xD;
           Serono S.A., Aubonne, Switzerland) at dosages from 150-225 IU/day is initiated on the&#xD;
           second or third day of menstruation.&#xD;
&#xD;
        -  When there are at least two or three follicles &gt;17 mm in diameter, recombinant human&#xD;
           chorionic gonadotropin (0.25 µgr ; Ovitrelle IM, Serono, Istanbul, Turkey) is applied&#xD;
           subcutaneously 34-36 hours before oocyte retrieval.&#xD;
&#xD;
        -  Serum samples are collected on day of HCG for study and control group patients.&#xD;
&#xD;
        -  Serum levels of ischemia modified albumin (IMA), malondialdehyde (MDA), total oxidative&#xD;
           capacity (TOS), total antioxidative capacity (TAS) and oxidative stress capacity (OSI)&#xD;
           levels.&#xD;
&#xD;
        -  This is a case control study&#xD;
&#xD;
        -  Statistical analyses will be performed using student t-test and fisher chi-square test.&#xD;
           The correlations between the serums IMA, TAC, TOC, OSI, and MDA levels will be examined&#xD;
           in all study groups using Spearman correlation analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">October 2014</completion_date>
  <primary_completion_date type="Anticipated">September 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change the levels of oxidative stress markers</measure>
    <time_frame>1 day</time_frame>
    <description>Serum will be obtained for studiying ischemia modified albumin (IMA), malondialdehyde (MDA), total oxidative capacity (TOS), total antioxidative capacity (TAS) and oxidative stress capacity (OSI) levels</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Ovarian Hyperstimulation Syndrome</condition>
  <arm_group>
    <arm_group_label>ovarian hyperstimulation patients</arm_group_label>
    <description>Moderate OHSS is defined as abdominal distension and discomfort, nausea with or without vomiting, ovarian enlargement (ovarian size of 8-12 cm) and ascites that revealed by ultrasonografic examination. Severe OHSS criteria is defined as ovarian enlargement, ascites with or without hydrothorax, haematocrit &gt;45%, weight gain &gt;2 kg, white blood cell count &gt;15.000, oliguria, creatinine of 1.0-1.5, creatinine clearance of &gt;50 ml/min, liver dysfunction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>without ovarian hiperstimulation</arm_group_label>
    <description>Control group is composed of patients who underwent long luteal protocol but do not demonstrate symptoms of OHSS</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood of involved patients in study was drawn for study for ischemia modified albumin (IMA),&#xD;
      malondialdehyde (MDA), total oxidative capacity (TOS), total antioxidative capacity (TAS) and&#xD;
      oxidative stress capacity (OSI) levels. After the study all blood samples will be destroyed&#xD;
      according to regulations.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients that are administered luteal long protocol for controlled ovarian stimulation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Patients in both groups are normoresponders or hyperresponders who will undergo assisted&#xD;
        reproductive technology for male factor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known inherited or acquired thrombophilia&#xD;
&#xD;
          -  previous thromboembolism&#xD;
&#xD;
          -  previous, current or planned anti-thrombotic treatment&#xD;
&#xD;
          -  first degree relatives with known genetic thrombophilia&#xD;
&#xD;
          -  systemic diseases&#xD;
&#xD;
          -  smoking.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>emine seda guvendag guven, MD</last_name>
    <role>Study Director</role>
    <affiliation>Karadeniz Technical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>rafet duraker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>T. C Etlik Zubeyde Hanim Women's health Teaching Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>emine seda guvendag guven, MD</last_name>
    <phone>905332339854</phone>
    <email>emineseda@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>suleyman guven, MD</last_name>
    <phone>90</phone>
    <email>drsuleymanguven@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>T.C Saglik Bakanligi Etlik Zübeyde Hanim Womens Health Teaching Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06600</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>rafet duraker, MD</last_name>
      <phone>905342325333</phone>
      <email>rafetduraker@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>yeşim bayoglu tekin, MD</last_name>
      <phone>05055171973</phone>
      <email>yesimbay@yahoo.com</email>
    </contact_backup>
    <investigator>
      <last_name>Serdar Dilbaz, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ahmet Mentese, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sevim Aydin, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Hitkari JA, Rowe TP, von Dadelszen P. Activated protein C and the ovarian hyperstimulation syndrome: possible therapeutic implications. Med Hypotheses. 2006;66(5):929-33. doi: 10.1016/j.mehy.2005.08.058. Epub 2006 Jan 24.</citation>
    <PMID>16434147</PMID>
  </reference>
  <reference>
    <citation>Westerlund E, Henriksson P, Wallen H, Hovatta O, Wallberg KR, Antovic A. Detection of a procoagulable state during controlled ovarian hyperstimulation for in vitro fertilization with global assays of haemostasis. Thromb Res. 2012 Oct;130(4):649-53. doi: 10.1016/j.thromres.2011.11.024. Epub 2011 Dec 7.</citation>
    <PMID>22154245</PMID>
  </reference>
  <reference>
    <citation>Agarwal A, Allamaneni SS. Role of free radicals in female reproductive diseases and assisted reproduction. Reprod Biomed Online. 2004 Sep;9(3):338-47. doi: 10.1016/s1472-6483(10)62151-7.</citation>
    <PMID>15353087</PMID>
  </reference>
  <reference>
    <citation>Velthut A, Zilmer M, Zilmer K, Kaart T, Karro H, Salumets A. Elevated blood plasma antioxidant status is favourable for achieving IVF/ICSI pregnancy. Reprod Biomed Online. 2013 Apr;26(4):345-52. doi: 10.1016/j.rbmo.2012.12.012. Epub 2013 Jan 16.</citation>
    <PMID>23415995</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>July 24, 2014</last_update_submitted>
  <last_update_submitted_qc>July 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karadeniz Technical University</investigator_affiliation>
    <investigator_full_name>emine seda guvendag guven</investigator_full_name>
    <investigator_title>medical doctor</investigator_title>
  </responsible_party>
  <keyword>ovarian hyperstimulation</keyword>
  <keyword>Oxidative Stress</keyword>
  <keyword>IMA</keyword>
  <keyword>OHSS</keyword>
  <keyword>ICSI</keyword>
  <keyword>long agonist protocol</keyword>
  <keyword>TAC</keyword>
  <keyword>TOS</keyword>
  <keyword>OSI</keyword>
  <keyword>MDA</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Hyperstimulation Syndrome</mesh_term>
  </condition_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/NCT02202278
org study id: 139EK1
nct id: NCT02202278
lead sponsor: 
has dmc: No
The aim of the study is to determine serum oxidative stress status by ischemia modified
      albumin (IMA), total antioxidant capacity (TAC), total oxidative capacity (TOS), oxidative
      stress capacity (OSI), and serum malondialdehyde (MDA) in patients with OHHS and control
      group. We also aim to reveal the association between serum levels of these factors and oocyte
      quality.
-  Patients included in this study were assisted reproductive technique (ART) patients with
           moderate and severe OHSS who were hospitalized for management

        -  Control patients are selected from patients without signs of OHSS

        -  All patients are administered luteal long protocol for controlled ovarian stimulation.
           Pituitary down-regulation with SC injection of GnRH agonist (GnRH-a) (1 mg/day; Lucrin,
           Abbott Laboratories, North Chicago, IL) that was started on day 21 of the previous
           menstrual cycle. Subcutaneous administration of recombinant hFSH (Gonal-F, Laboratories
           Serono S.A., Aubonne, Switzerland) at dosages from 150-225 IU/day is initiated on the
           second or third day of menstruation.

        -  When there are at least two or three follicles >17 mm in diameter, recombinant human
           chorionic gonadotropin (0.25 µgr ; Ovitrelle IM, Serono, Istanbul, Turkey) is applied
           subcutaneously 34-36 hours before oocyte retrieval.

        -  Serum samples are collected on day of HCG for study and control group patients.

        -  Serum levels of ischemia modified albumin (IMA), malondialdehyde (MDA), total oxidative
           capacity (TOS), total antioxidative capacity (TAS) and oxidative stress capacity (OSI)
           levels.

        -  This is a case control study

        -  Statistical analyses will be performed using student t-test and fisher chi-square test.
           The correlations between the serums IMA, TAC, TOC, OSI, and MDA levels will be examined
           in all study groups using Spearman correlation analysis.
observational model: Case-Control
time perspective: Prospective
measure: Change the levels of oxidative stress markers
time frame: 1 day
description: Serum will be obtained for studiying ischemia modified albumin (IMA), malondialdehyde (MDA), total oxidative capacity (TOS), total antioxidative capacity (TAS) and oxidative stress capacity (OSI) levels
arm group label: ovarian hyperstimulation patients
description: Moderate OHSS is defined as abdominal distension and discomfort, nausea with or without vomiting, ovarian enlargement (ovarian size of 8-12 cm) and ascites that revealed by ultrasonografic examination. Severe OHSS criteria is defined as ovarian enlargement, ascites with or without hydrothorax, haematocrit >45%, weight gain >2 kg, white blood cell count >15.000, oliguria, creatinine of 1.0-1.5, creatinine clearance of >50 ml/min, liver dysfunction.
arm group label: without ovarian hiperstimulation
description: Control group is composed of patients who underwent long luteal protocol but do not demonstrate symptoms of OHSS
Blood of involved patients in study was drawn for study for ischemia modified albumin (IMA),
      malondialdehyde (MDA), total oxidative capacity (TOS), total antioxidative capacity (TAS) and
      oxidative stress capacity (OSI) levels. After the study all blood samples will be destroyed
      according to regulations.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: emine seda guvendag guven, MD
role: Study Director
affiliation: Karadeniz Technical University
last name: rafet duraker, MD
role: Principal Investigator
affiliation: T. C Etlik Zubeyde Hanim Women's health Teaching Hospital
last name: emine seda guvendag guven, MD
phone: 905332339854
email: emineseda@yahoo.com
last name: suleyman guven, MD
phone: 90
email: drsuleymanguven@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Turkey
citation: Hitkari JA, Rowe TP, von Dadelszen P. Activated protein C and the ovarian hyperstimulation syndrome: possible therapeutic implications. Med Hypotheses. 2006;66(5):929-33. doi: 10.1016/j.mehy.2005.08.058. Epub 2006 Jan 24.
PMID: 16434147
citation: Westerlund E, Henriksson P, Wallen H, Hovatta O, Wallberg KR, Antovic A. Detection of a procoagulable state during controlled ovarian hyperstimulation for in vitro fertilization with global assays of haemostasis. Thromb Res. 2012 Oct;130(4):649-53. doi: 10.1016/j.thromres.2011.11.024. Epub 2011 Dec 7.
PMID: 22154245
citation: Agarwal A, Allamaneni SS. Role of free radicals in female reproductive diseases and assisted reproduction. Reprod Biomed Online. 2004 Sep;9(3):338-47. doi: 10.1016/s1472-6483(10)62151-7.
PMID: 15353087
citation: Velthut A, Zilmer M, Zilmer K, Kaart T, Karro H, Salumets A. Elevated blood plasma antioxidant status is favourable for achieving IVF/ICSI pregnancy. Reprod Biomed Online. 2013 Apr;26(4):345-52. doi: 10.1016/j.rbmo.2012.12.012. Epub 2013 Jan 16.
PMID: 23415995
responsible party type: Principal Investigator
investigator affiliation: Karadeniz Technical University
investigator full name: emine seda guvendag guven
investigator title: medical doctor
mesh term: Ovarian Hyperstimulation Syndrome