<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/NCT02975713</url>
  </required_header>
  <id_info>
    <org_study_id>1609-ABU-070-HF</org_study_id>
    <nct_id>NCT02975713</nct_id>
  </id_info>
  <brief_title>Progesterone Diurnal Rhythm During Ovarian Stimulation for IVF</brief_title>
  <official_title>Progesterone Diurnal Rhythm During Ovarian Stimulation for IVF</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ART Fertility Clinics LLC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ART Fertility Clinics LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the influence of circadian rhythm on progesterone levels during follicular phase&#xD;
      of natural cycle and during follicular phase of controlled ovarian stimulation during IVF.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of this study is to determine the circadian rhythm of progesterone in a&#xD;
      stimulated cycle. Sample size calculations show that the study needs to recruit 10 women to&#xD;
      show any significant differences in progesterone secreted in the morning at 8 am compared to&#xD;
      that secreted in the evening at 8 pm. We have increased the number of participants to 12 in&#xD;
      order to compensate for any possible drop outs. The hormones FSH, LH, Progesterone and&#xD;
      Estradiol will be measured at days 2/3, 8, 10 and 12 of a normal and stimulated cycle so that&#xD;
      each patient serves as her own control.&#xD;
&#xD;
      This study will provide the basis to establish the optimal blood sampling time for&#xD;
      progesterone measurement and to more accurately determine the cut-off level for progesterone&#xD;
      for favourable pregnancy outcomes in ART.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    no participants were recruited,study stopped&#xD;
  </why_stopped>
  <start_date type="Actual">November 2, 2017</start_date>
  <completion_date type="Actual">November 15, 2017</completion_date>
  <primary_completion_date type="Actual">November 14, 2017</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>Progesterone levels during follicular phase</measure>
    <time_frame>2-4 months</time_frame>
    <description>The primary aim of this study is to determine the circadian rhythm of progesterone in a stimulated cycle.</description>
  </primary_outcome>
  <enrollment type="Actual">12</enrollment>
  <condition>Ovarian Hyperstimulation</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood samples extracted from the vein&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have to undergo IVF due to primary or secondary infertility.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indication for IVF / ICSI - treatment&#xD;
&#xD;
          -  Age ≥ 18 years and ≤ 35 years&#xD;
&#xD;
          -  Ovarian reserve parameters in the adequate age - range, determined by&#xD;
             Anti-Mullerian-Hormone (AMH) and Antral Follicle Count (AFC)(16)&#xD;
&#xD;
          -  Able to understand the aim of the study and to provide consent&#xD;
&#xD;
          -  Regular cycle (25-35 days)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of polycystic ovarian syndrome (PCOS) Rotterdam criteria&#xD;
&#xD;
          -  Endometriosis stage 3 or 4 AFS&#xD;
&#xD;
          -  Treatment with GnRH-analogues during the previous 6 months&#xD;
&#xD;
          -  Intake of oral contraceptive pill (OCP) or any hormonal treatment during the last 3&#xD;
             months&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Human Mo Fatemi, Medical Director</last_name>
    <role>Principal Investigator</role>
    <affiliation>IVI Middle East Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IVI Middle East Fertilty Clinic</name>
      <address>
        <city>Abu Dhabi</city>
        <country>United Arab Emirates</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Arab Emirates</country>
  </location_countries>
  <reference>
    <citation>Fatemi HM, Van Vaerenbergh I. Significance of premature progesterone rise in IVF. Curr Opin Obstet Gynecol. 2015 Jun;27(3):242-8. doi: 10.1097/GCO.0000000000000172.</citation>
    <PMID>25811257</PMID>
  </reference>
  <reference>
    <citation>Patton PE, Lim JY, Hickok LR, Kettel LM, Larson JM, Pau KY. Precision of progesterone measurements with the use of automated immunoassay analyzers and the impact on clinical decisions for in vitro fertilization. Fertil Steril. 2014 Jun;101(6):1629-36. doi: 10.1016/j.fertnstert.2014.02.037. Epub 2014 Mar 21.</citation>
    <PMID>24661729</PMID>
  </reference>
  <results_reference>
    <citation>Venetis CA, Kolibianakis EM, Bosdou JK, Tarlatzis BC. Progesterone elevation and probability of pregnancy after IVF: a systematic review and meta-analysis of over 60 000 cycles. Hum Reprod Update. 2013 Sep-Oct;19(5):433-57. doi: 10.1093/humupd/dmt014. Epub 2013 Jul 4.</citation>
    <PMID>23827986</PMID>
  </results_reference>
  <results_reference>
    <citation>Huang R, Fang C, Xu S, Yi Y, Liang X. Premature progesterone rise negatively correlated with live birth rate in IVF cycles with GnRH agonist: an analysis of 2,566 cycles. Fertil Steril. 2012 Sep;98(3):664-670.e2. doi: 10.1016/j.fertnstert.2012.05.024. Epub 2012 Jun 15.</citation>
    <PMID>22704632</PMID>
  </results_reference>
  <results_reference>
    <citation>Ochsenkuhn R, Arzberger A, von Schonfeldt V, Gallwas J, Rogenhofer N, Crispin A, Thaler CJ, Noss U. Subtle progesterone rise on the day of human chorionic gonadotropin administration is associated with lower live birth rates in women undergoing assisted reproductive technology: a retrospective study with 2,555 fresh embryo transfers. Fertil Steril. 2012 Aug;98(2):347-54. doi: 10.1016/j.fertnstert.2012.04.041. Epub 2012 May 24.</citation>
    <PMID>22633265</PMID>
  </results_reference>
  <results_reference>
    <citation>Xu B, Li Z, Zhang H, Jin L, Li Y, Ai J, Zhu G. Serum progesterone level effects on the outcome of in vitro fertilization in patients with different ovarian response: an analysis of more than 10,000 cycles. Fertil Steril. 2012 Jun;97(6):1321-7.e1-4. doi: 10.1016/j.fertnstert.2012.03.014. Epub 2012 Apr 10.</citation>
    <PMID>22494924</PMID>
  </results_reference>
  <results_reference>
    <citation>Labarta E, Martinez-Conejero JA, Alama P, Horcajadas JA, Pellicer A, Simon C, Bosch E. Endometrial receptivity is affected in women with high circulating progesterone levels at the end of the follicular phase: a functional genomics analysis. Hum Reprod. 2011 Jul;26(7):1813-25. doi: 10.1093/humrep/der126. Epub 2011 May 2.</citation>
    <PMID>21540246</PMID>
  </results_reference>
  <results_reference>
    <citation>Van Vaerenbergh I, Fatemi HM, Blockeel C, Van Lommel L, In't Veld P, Schuit F, Kolibianakis EM, Devroey P, Bourgain C. Progesterone rise on HCG day in GnRH antagonist/rFSH stimulated cycles affects endometrial gene expression. Reprod Biomed Online. 2011 Mar;22(3):263-71. doi: 10.1016/j.rbmo.2010.11.002. Epub 2010 Nov 13.</citation>
    <PMID>21273126</PMID>
  </results_reference>
  <results_reference>
    <citation>Bosch E, Labarta E, Crespo J, Simon C, Remohi J, Jenkins J, Pellicer A. Circulating progesterone levels and ongoing pregnancy rates in controlled ovarian stimulation cycles for in vitro fertilization: analysis of over 4000 cycles. Hum Reprod. 2010 Aug;25(8):2092-100. doi: 10.1093/humrep/deq125. Epub 2010 Jun 10.</citation>
    <PMID>20539042</PMID>
  </results_reference>
  <results_reference>
    <citation>Kyrou D, Popovic-Todorovic B, Fatemi HM, Bourgain C, Haentjens P, Van Landuyt L, Devroey P. Does the estradiol level on the day of human chorionic gonadotrophin administration have an impact on pregnancy rates in patients treated with rec-FSH/GnRH antagonist? Hum Reprod. 2009 Nov;24(11):2902-9. doi: 10.1093/humrep/dep290. Epub 2009 Aug 11.</citation>
    <PMID>19671625</PMID>
  </results_reference>
  <results_reference>
    <citation>Strott CA, Yoshimi T, Lipsett MB. Plasma progesterone and 17-hydroxyprogesterone in normal men and children with congenital adrenal hyperplasia. J Clin Invest. 1969 May;48(5):930-9. doi: 10.1172/JCI106052.</citation>
    <PMID>4305376</PMID>
  </results_reference>
  <results_reference>
    <citation>Bungum L, Jacobsson AK, Rosen F, Becker C, Yding Andersen C, Guner N, Giwercman A. Circadian variation in concentration of anti-Mullerian hormone in regularly menstruating females: relation to age, gonadotrophin and sex steroid levels. Hum Reprod. 2011 Mar;26(3):678-84. doi: 10.1093/humrep/deq380. Epub 2011 Jan 11.</citation>
    <PMID>21227943</PMID>
  </results_reference>
  <results_reference>
    <citation>Bungum L, Franssohn F, Bungum M, Humaidan P, Giwercman A. The circadian variation in Anti-Mullerian hormone in patients with polycystic ovary syndrome differs significantly from normally ovulating women. PLoS One. 2013 Sep 4;8(9):e68223. doi: 10.1371/journal.pone.0068223. eCollection 2013.</citation>
    <PMID>24023708</PMID>
  </results_reference>
  <results_reference>
    <citation>Seifer DB, Baker VL, Leader B. Age-specific serum anti-Mullerian hormone values for 17,120 women presenting to fertility centers within the United States. Fertil Steril. 2011 Feb;95(2):747-50. doi: 10.1016/j.fertnstert.2010.10.011. Epub 2010 Nov 13.</citation>
    <PMID>21074758</PMID>
  </results_reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>February 27, 2018</last_update_submitted>
  <last_update_submitted_qc>February 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>ART Fertility Clinics LLC</investigator_affiliation>
    <investigator_full_name>Prof Dr. Human Fatemi</investigator_full_name>
    <investigator_title>Medical Director</investigator_title>
  </responsible_party>
  <keyword>P4,ART,IVF,FSH,LH,AMH</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02975713
org study id: 1609-ABU-070-HF
nct id: NCT02975713
lead sponsor: 
has dmc: No
To evaluate the influence of circadian rhythm on progesterone levels during follicular phase
      of natural cycle and during follicular phase of controlled ovarian stimulation during IVF.
The primary aim of this study is to determine the circadian rhythm of progesterone in a
      stimulated cycle. Sample size calculations show that the study needs to recruit 10 women to
      show any significant differences in progesterone secreted in the morning at 8 am compared to
      that secreted in the evening at 8 pm. We have increased the number of participants to 12 in
      order to compensate for any possible drop outs. The hormones FSH, LH, Progesterone and
      Estradiol will be measured at days 2/3, 8, 10 and 12 of a normal and stimulated cycle so that
      each patient serves as her own control.

      This study will provide the basis to establish the optimal blood sampling time for
      progesterone measurement and to more accurately determine the cut-off level for progesterone
      for favourable pregnancy outcomes in ART.
observational model: Case-Control
time perspective: Prospective
measure: Progesterone levels during follicular phase
time frame: 2-4 months
description: The primary aim of this study is to determine the circadian rhythm of progesterone in a stimulated cycle.
blood samples extracted from the vein
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Human Mo Fatemi, Medical Director
role: Principal Investigator
affiliation: IVI Middle East Clinic
facility: 
country: United Arab Emirates
citation: Fatemi HM, Van Vaerenbergh I. Significance of premature progesterone rise in IVF. Curr Opin Obstet Gynecol. 2015 Jun;27(3):242-8. doi: 10.1097/GCO.0000000000000172.
PMID: 25811257
citation: Patton PE, Lim JY, Hickok LR, Kettel LM, Larson JM, Pau KY. Precision of progesterone measurements with the use of automated immunoassay analyzers and the impact on clinical decisions for in vitro fertilization. Fertil Steril. 2014 Jun;101(6):1629-36. doi: 10.1016/j.fertnstert.2014.02.037. Epub 2014 Mar 21.
PMID: 24661729
citation: Venetis CA, Kolibianakis EM, Bosdou JK, Tarlatzis BC. Progesterone elevation and probability of pregnancy after IVF: a systematic review and meta-analysis of over 60 000 cycles. Hum Reprod Update. 2013 Sep-Oct;19(5):433-57. doi: 10.1093/humupd/dmt014. Epub 2013 Jul 4.
PMID: 23827986
citation: Huang R, Fang C, Xu S, Yi Y, Liang X. Premature progesterone rise negatively correlated with live birth rate in IVF cycles with GnRH agonist: an analysis of 2,566 cycles. Fertil Steril. 2012 Sep;98(3):664-670.e2. doi: 10.1016/j.fertnstert.2012.05.024. Epub 2012 Jun 15.
PMID: 22704632
citation: Ochsenkuhn R, Arzberger A, von Schonfeldt V, Gallwas J, Rogenhofer N, Crispin A, Thaler CJ, Noss U. Subtle progesterone rise on the day of human chorionic gonadotropin administration is associated with lower live birth rates in women undergoing assisted reproductive technology: a retrospective study with 2,555 fresh embryo transfers. Fertil Steril. 2012 Aug;98(2):347-54. doi: 10.1016/j.fertnstert.2012.04.041. Epub 2012 May 24.
PMID: 22633265
citation: Xu B, Li Z, Zhang H, Jin L, Li Y, Ai J, Zhu G. Serum progesterone level effects on the outcome of in vitro fertilization in patients with different ovarian response: an analysis of more than 10,000 cycles. Fertil Steril. 2012 Jun;97(6):1321-7.e1-4. doi: 10.1016/j.fertnstert.2012.03.014. Epub 2012 Apr 10.
PMID: 22494924
citation: Labarta E, Martinez-Conejero JA, Alama P, Horcajadas JA, Pellicer A, Simon C, Bosch E. Endometrial receptivity is affected in women with high circulating progesterone levels at the end of the follicular phase: a functional genomics analysis. Hum Reprod. 2011 Jul;26(7):1813-25. doi: 10.1093/humrep/der126. Epub 2011 May 2.
PMID: 21540246
citation: Van Vaerenbergh I, Fatemi HM, Blockeel C, Van Lommel L, In't Veld P, Schuit F, Kolibianakis EM, Devroey P, Bourgain C. Progesterone rise on HCG day in GnRH antagonist/rFSH stimulated cycles affects endometrial gene expression. Reprod Biomed Online. 2011 Mar;22(3):263-71. doi: 10.1016/j.rbmo.2010.11.002. Epub 2010 Nov 13.
PMID: 21273126
citation: Bosch E, Labarta E, Crespo J, Simon C, Remohi J, Jenkins J, Pellicer A. Circulating progesterone levels and ongoing pregnancy rates in controlled ovarian stimulation cycles for in vitro fertilization: analysis of over 4000 cycles. Hum Reprod. 2010 Aug;25(8):2092-100. doi: 10.1093/humrep/deq125. Epub 2010 Jun 10.
PMID: 20539042
citation: Kyrou D, Popovic-Todorovic B, Fatemi HM, Bourgain C, Haentjens P, Van Landuyt L, Devroey P. Does the estradiol level on the day of human chorionic gonadotrophin administration have an impact on pregnancy rates in patients treated with rec-FSH/GnRH antagonist? Hum Reprod. 2009 Nov;24(11):2902-9. doi: 10.1093/humrep/dep290. Epub 2009 Aug 11.
PMID: 19671625
citation: Strott CA, Yoshimi T, Lipsett MB. Plasma progesterone and 17-hydroxyprogesterone in normal men and children with congenital adrenal hyperplasia. J Clin Invest. 1969 May;48(5):930-9. doi: 10.1172/JCI106052.
PMID: 4305376
citation: Bungum L, Jacobsson AK, Rosen F, Becker C, Yding Andersen C, Guner N, Giwercman A. Circadian variation in concentration of anti-Mullerian hormone in regularly menstruating females: relation to age, gonadotrophin and sex steroid levels. Hum Reprod. 2011 Mar;26(3):678-84. doi: 10.1093/humrep/deq380. Epub 2011 Jan 11.
PMID: 21227943
citation: Bungum L, Franssohn F, Bungum M, Humaidan P, Giwercman A. The circadian variation in Anti-Mullerian hormone in patients with polycystic ovary syndrome differs significantly from normally ovulating women. PLoS One. 2013 Sep 4;8(9):e68223. doi: 10.1371/journal.pone.0068223. eCollection 2013.
PMID: 24023708
citation: Seifer DB, Baker VL, Leader B. Age-specific serum anti-Mullerian hormone values for 17,120 women presenting to fertility centers within the United States. Fertil Steril. 2011 Feb;95(2):747-50. doi: 10.1016/j.fertnstert.2010.10.011. Epub 2010 Nov 13.
PMID: 21074758
responsible party type: Principal Investigator
investigator affiliation: ART Fertility Clinics LLC
investigator full name: Prof Dr. Human Fatemi
investigator title: Medical Director
sharing ipd: No