<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/NCT02999568</url>
  </required_header>
  <id_info>
    <org_study_id>Meir Medical Center - Sport</org_study_id>
    <nct_id>NCT02999568</nct_id>
  </id_info>
  <brief_title>The Effect of Exercise on Ovarian Reserve</brief_title>
  <official_title>Open Study to Examine How Different Levels of Physical Activity Impact the Ovarian Reserve During the Pre-menopausal Period</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine how different levels of physical activity impact the&#xD;
      ovarian reserve during the pre-menopausal period&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Two groups are included:&#xD;
&#xD;
        1. The study group: women between 20-35 years of age who practice high level of physical&#xD;
           activity, as defined by International Physical Activity Questionnaire , for the past 3&#xD;
           years&#xD;
&#xD;
        2. The control group: women between 20-35 years of age who practice low level of physical&#xD;
           activity, as defined by International Physical Activity Questionnaire , for the past 3&#xD;
           years&#xD;
&#xD;
      Women who meet the criteria for inclusion for will be recruited to the study after signing a&#xD;
      consent form. Recruitment will be done through sport centers. The control group will include&#xD;
      women being examined in gynecologic emergency department, after signing a consent form, if&#xD;
      they meet the control group's inclusion criteria. These women will be asked to fulfill the&#xD;
      International Physical Activity Questionnaire and additional questionnaire regarding relevant&#xD;
      demographic and medical information (see below). Blood samples to anti-mullerian hormone ,&#xD;
      leptin, and hormonal profile will be obtained in day 3 of menstruation. Ultrasound will be&#xD;
      performed to measure Antral Follicular count and ovarian blood flow.&#xD;
&#xD;
      Data collection:&#xD;
&#xD;
        1. Demographic information on age, weight, height, BMI, marital status&#xD;
&#xD;
        2. Medical information regarding chronic diseases and medications&#xD;
&#xD;
        3. Obstetrical history&#xD;
&#xD;
        4. Information regarding physical activities in the version of International Physical&#xD;
           Activity Questionnaire .&#xD;
&#xD;
        5. Information about menstrual behavior: irregularity (yes/no) frequency (less than 21 days&#xD;
           between 21-35 days, over 35 days), menstrual duration (less than 3 days 3-7 days, or&#xD;
           over 7 days) bleeding amount according to the number of pads per day (up to 1, 2, 4 or 5&#xD;
           pads).&#xD;
&#xD;
        6. Hormonal profile - Follicle-stimulating hormone , Luteinizing hormone , progesterone,&#xD;
           Estradiol, Thyroid-stimulating hormone .&#xD;
&#xD;
        7. Antral Follicle Count, Anti-mullerian hormone&#xD;
&#xD;
        8. Leptin levels -reflecting metabolic changes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <completion_date type="Anticipated">August 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2019</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>Levels of anti-mullerian hormone</measure>
    <time_frame>3 days after period</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Antral Follicle Count</measure>
    <time_frame>3 days after period</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Levels of Follicle-stimulating hormone</measure>
    <time_frame>3 days after period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>levels fo Luteinizing hormone</measure>
    <time_frame>3 days after period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of progesterone</measure>
    <time_frame>3 days after period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of estradiol</measure>
    <time_frame>3 days after period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of Thyroid-stimulating hormone</measure>
    <time_frame>3 days after period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of leptin</measure>
    <time_frame>3 days after period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Menstrual duration</measure>
    <time_frame>3 days after period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>frequency of bleeding in every menstruation</measure>
    <time_frame>3 days after period</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>amount of bleeding in every menstruation</measure>
    <time_frame>3 days after period</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Physical Exercise</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <description>Women who practice high level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Women who practice low level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physical exercise</intervention_name>
    <description>Women who practice high level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years will be recruited. These women will will be asked to fulfill the International Physical Activity Questionnaire and additional questionnaire regarding relevant demographic and medical information. Blood samples to anti-mullerian hormone , leptin, and hormonal profile will be obtained in day 3 of menstruation. Ultrasound will be performed to measure Antral Follicular count and ovarian blood flow</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Control group - Recruitment will be done through Gynocologis tEmergency Experimental group&#xD;
        - Recruitment will be done through sport centers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Study group:&#xD;
&#xD;
          1. Women between 20-35 years of age who practice high level of physical activity, as&#xD;
             defined by International Physical Activity Questionnaire, for the past 3 years&#xD;
&#xD;
          2. BMI 18-25&#xD;
&#xD;
          3. Regular menstruation&#xD;
&#xD;
        Control group:&#xD;
&#xD;
          1. Women between 20-35 years of age who practice low level of physical activity, as&#xD;
             defined by International Physical Activity Questionnaire, for the past 3 years&#xD;
&#xD;
          2. BMI 18-25&#xD;
&#xD;
          3. Regular menstruation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Polycystic ovary syndrome 2. Endometriosis 3. Diabetes 4. Hyper/hypothyroidism 5.&#xD;
        BMI&gt;25, BMI&lt;18 6. Active or past eating disorder&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yael Pasternak, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meir Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amir Wiser, MD</last_name>
    <phone>07297472901</phone>
    <email>Amir.Wiser@clalit.org.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Helsinki Committee MMC</last_name>
    <phone>97297471588</phone>
  </overall_contact_backup>
  <link>
    <url>http://www.ipaq.ki.se</url>
    <description>International Physical Activity Questionnaire</description>
  </link>
  <reference>
    <citation>Pate RR, Pratt M, Blair SN, Haskell WL, Macera CA, Bouchard C, Buchner D, Ettinger W, Heath GW, King AC, et al. Physical activity and public health. A recommendation from the Centers for Disease Control and Prevention and the American College of Sports Medicine. JAMA. 1995 Feb 1;273(5):402-7. doi: 10.1001/jama.273.5.402.</citation>
    <PMID>7823386</PMID>
  </reference>
  <reference>
    <citation>Clapp JF 3rd. Exercise during pregnancy. A clinical update. Clin Sports Med. 2000 Apr;19(2):273-86. doi: 10.1016/s0278-5919(05)70203-9.</citation>
    <PMID>10740759</PMID>
  </reference>
  <reference>
    <citation>Duckitt K. Exercise during pregnancy. BMJ. 2011 Sep 15;343:d5710. doi: 10.1136/bmj.d5710. No abstract available.</citation>
    <PMID>21920880</PMID>
  </reference>
  <reference>
    <citation>Rich-Edwards JW, Spiegelman D, Garland M, Hertzmark E, Hunter DJ, Colditz GA, Willett WC, Wand H, Manson JE. Physical activity, body mass index, and ovulatory disorder infertility. Epidemiology. 2002 Mar;13(2):184-90. doi: 10.1097/00001648-200203000-00013.</citation>
    <PMID>11880759</PMID>
  </reference>
  <reference>
    <citation>Oosthuyse T, Bosch AN. The effect of the menstrual cycle on exercise metabolism: implications for exercise performance in eumenorrhoeic women. Sports Med. 2010 Mar 1;40(3):207-27. doi: 10.2165/11317090-000000000-00000.</citation>
    <PMID>20199120</PMID>
  </reference>
  <reference>
    <citation>Clark AM, Ledger W, Galletly C, Tomlinson L, Blaney F, Wang X, Norman RJ. Weight loss results in significant improvement in pregnancy and ovulation rates in anovulatory obese women. Hum Reprod. 1995 Oct;10(10):2705-12. doi: 10.1093/oxfordjournals.humrep.a135772.</citation>
    <PMID>8567797</PMID>
  </reference>
  <reference>
    <citation>Hollmann M, Runnebaum B, Gerhard I. Effects of weight loss on the hormonal profile in obese, infertile women. Hum Reprod. 1996 Sep;11(9):1884-91. doi: 10.1093/oxfordjournals.humrep.a019512.</citation>
    <PMID>8921059</PMID>
  </reference>
  <reference>
    <citation>Morris SN, Missmer SA, Cramer DW, Powers RD, McShane PM, Hornstein MD. Effects of lifetime exercise on the outcome of in vitro fertilization. Obstet Gynecol. 2006 Oct;108(4):938-45. doi: 10.1097/01.AOG.0000235704.45652.0b.</citation>
    <PMID>17012457</PMID>
  </reference>
  <reference>
    <citation>Evenson KR, Calhoun KC, Herring AH, Pritchard D, Wen F, Steiner AZ. Association of physical activity in the past year and immediately after in vitro fertilization on pregnancy. Fertil Steril. 2014 Apr;101(4):1047-1054.e5. doi: 10.1016/j.fertnstert.2013.12.041. Epub 2014 Feb 10.</citation>
    <PMID>24524834</PMID>
  </reference>
  <reference>
    <citation>Masse LC, de Niet JE. Sources of validity evidence needed with self-report measures of physical activity. J Phys Act Health. 2012 Jan;9 Suppl 1:S44-55. doi: 10.1123/jpah.9.s1.s44.</citation>
    <PMID>22287447</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>December 18, 2016</last_update_submitted>
  <last_update_submitted_qc>December 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Meir Medical Center</investigator_affiliation>
    <investigator_full_name>Yael Pasternak</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <!-- 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/NCT02999568
org study id: Meir Medical Center - Sport
nct id: NCT02999568
lead sponsor: 
has dmc: No
The purpose of this study is to examine how different levels of physical activity impact the
      ovarian reserve during the pre-menopausal period
Two groups are included:

        1. The study group: women between 20-35 years of age who practice high level of physical
           activity, as defined by International Physical Activity Questionnaire , for the past 3
           years

        2. The control group: women between 20-35 years of age who practice low level of physical
           activity, as defined by International Physical Activity Questionnaire , for the past 3
           years

      Women who meet the criteria for inclusion for will be recruited to the study after signing a
      consent form. Recruitment will be done through sport centers. The control group will include
      women being examined in gynecologic emergency department, after signing a consent form, if
      they meet the control group's inclusion criteria. These women will be asked to fulfill the
      International Physical Activity Questionnaire and additional questionnaire regarding relevant
      demographic and medical information (see below). Blood samples to anti-mullerian hormone ,
      leptin, and hormonal profile will be obtained in day 3 of menstruation. Ultrasound will be
      performed to measure Antral Follicular count and ovarian blood flow.

      Data collection:

        1. Demographic information on age, weight, height, BMI, marital status

        2. Medical information regarding chronic diseases and medications

        3. Obstetrical history

        4. Information regarding physical activities in the version of International Physical
           Activity Questionnaire .

        5. Information about menstrual behavior: irregularity (yes/no) frequency (less than 21 days
           between 21-35 days, over 35 days), menstrual duration (less than 3 days 3-7 days, or
           over 7 days) bleeding amount according to the number of pads per day (up to 1, 2, 4 or 5
           pads).

        6. Hormonal profile - Follicle-stimulating hormone , Luteinizing hormone , progesterone,
           Estradiol, Thyroid-stimulating hormone .

        7. Antral Follicle Count, Anti-mullerian hormone

        8. Leptin levels -reflecting metabolic changes.
observational model: Case-Control
time perspective: Prospective
measure: Levels of anti-mullerian hormone
time frame: 3 days after period
measure: Number of Antral Follicle Count
time frame: 3 days after period
measure: Levels of Follicle-stimulating hormone
time frame: 3 days after period
measure: levels fo Luteinizing hormone
time frame: 3 days after period
measure: Levels of progesterone
time frame: 3 days after period
measure: Levels of estradiol
time frame: 3 days after period
measure: Levels of Thyroid-stimulating hormone
time frame: 3 days after period
measure: Levels of leptin
time frame: 3 days after period
measure: Menstrual duration
time frame: 3 days after period
measure: frequency of bleeding in every menstruation
time frame: 3 days after period
measure: amount of bleeding in every menstruation
time frame: 3 days after period
arm group label: Experimental
description: Women who practice high level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years
arm group label: Control group
description: Women who practice low level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years
intervention type: Other
intervention name: Physical exercise
description: Women who practice high level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years will be recruited. These women will will be asked to fulfill the International Physical Activity Questionnaire and additional questionnaire regarding relevant demographic and medical information. Blood samples to anti-mullerian hormone , leptin, and hormonal profile will be obtained in day 3 of menstruation. Ultrasound will be performed to measure Antral Follicular count and ovarian blood flow
arm group label: Experimental
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yael Pasternak, MD
role: Principal Investigator
affiliation: Meir Medical Center
last name: Amir Wiser, MD
phone: 07297472901
email: Amir.Wiser@clalit.org.il
last name: Helsinki Committee MMC
phone: 97297471588
url: http://www.ipaq.ki.se
description: International Physical Activity Questionnaire
citation: Pate RR, Pratt M, Blair SN, Haskell WL, Macera CA, Bouchard C, Buchner D, Ettinger W, Heath GW, King AC, et al. Physical activity and public health. A recommendation from the Centers for Disease Control and Prevention and the American College of Sports Medicine. JAMA. 1995 Feb 1;273(5):402-7. doi: 10.1001/jama.273.5.402.
PMID: 7823386
citation: Clapp JF 3rd. Exercise during pregnancy. A clinical update. Clin Sports Med. 2000 Apr;19(2):273-86. doi: 10.1016/s0278-5919(05)70203-9.
PMID: 10740759
citation: Duckitt K. Exercise during pregnancy. BMJ. 2011 Sep 15;343:d5710. doi: 10.1136/bmj.d5710. No abstract available.
PMID: 21920880
citation: Rich-Edwards JW, Spiegelman D, Garland M, Hertzmark E, Hunter DJ, Colditz GA, Willett WC, Wand H, Manson JE. Physical activity, body mass index, and ovulatory disorder infertility. Epidemiology. 2002 Mar;13(2):184-90. doi: 10.1097/00001648-200203000-00013.
PMID: 11880759
citation: Oosthuyse T, Bosch AN. The effect of the menstrual cycle on exercise metabolism: implications for exercise performance in eumenorrhoeic women. Sports Med. 2010 Mar 1;40(3):207-27. doi: 10.2165/11317090-000000000-00000.
PMID: 20199120
citation: Clark AM, Ledger W, Galletly C, Tomlinson L, Blaney F, Wang X, Norman RJ. Weight loss results in significant improvement in pregnancy and ovulation rates in anovulatory obese women. Hum Reprod. 1995 Oct;10(10):2705-12. doi: 10.1093/oxfordjournals.humrep.a135772.
PMID: 8567797
citation: Hollmann M, Runnebaum B, Gerhard I. Effects of weight loss on the hormonal profile in obese, infertile women. Hum Reprod. 1996 Sep;11(9):1884-91. doi: 10.1093/oxfordjournals.humrep.a019512.
PMID: 8921059
citation: Morris SN, Missmer SA, Cramer DW, Powers RD, McShane PM, Hornstein MD. Effects of lifetime exercise on the outcome of in vitro fertilization. Obstet Gynecol. 2006 Oct;108(4):938-45. doi: 10.1097/01.AOG.0000235704.45652.0b.
PMID: 17012457
citation: Evenson KR, Calhoun KC, Herring AH, Pritchard D, Wen F, Steiner AZ. Association of physical activity in the past year and immediately after in vitro fertilization on pregnancy. Fertil Steril. 2014 Apr;101(4):1047-1054.e5. doi: 10.1016/j.fertnstert.2013.12.041. Epub 2014 Feb 10.
PMID: 24524834
citation: Masse LC, de Niet JE. Sources of validity evidence needed with self-report measures of physical activity. J Phys Act Health. 2012 Jan;9 Suppl 1:S44-55. doi: 10.1123/jpah.9.s1.s44.
PMID: 22287447
responsible party type: Principal Investigator
investigator affiliation: Meir Medical Center
investigator full name: Yael Pasternak
investigator title: MD