<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/NCT03001492</url>
  </required_header>
  <id_info>
    <org_study_id>Progesterone</org_study_id>
    <nct_id>NCT03001492</nct_id>
  </id_info>
  <brief_title>Does Premature Luteinization Matter?</brief_title>
  <official_title>Does Measurement of Serum Progesterone on the Day of Trigger Matter?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Elevation of serum progesterone on the day of ovulation triggering in IVF/ICSI cycles is&#xD;
      suggested to be associated with compromized outcomes. Others found that this rise didnot&#xD;
      affect the IVF/ICSI outcomes. It is still controversal if premature luteinization would&#xD;
      affect the IVF/ICSI outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <primary_completion_date type="Anticipated">June 2018</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>Clinical pregnacy rate</measure>
    <time_frame>14 days after the day of embryo transfer (ET)</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Premature Progesterone Rise</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All the women undergo controlled ovarian hyperstimulation for IVF/ICSI. only fresh cycles&#xD;
        will be involved&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Planned fresh Embryo transfer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cancelation of the embryo transfer for any reason&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Osama Abdalmageed</last_name>
    <role>Principal Investigator</role>
    <affiliation>Women health center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Osama Abdalmageed</last_name>
    <email>drosamast1981@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Osama Abdalmageed</name>
      <address>
        <city>Assiut</city>
        <state>Non-US/Non-Canadian</state>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Osama Abdalmageed</last_name>
      <email>drosamast1981@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Sonmezer M, Pelin Cil A, Atabekoglu C, Ozkavukcu S, Ozmen B. Does premature luteinization or early surge of LH impair cycle outcome? Report of two successful outcomes. J Assist Reprod Genet. 2009 Mar;26(2-3):159-63. doi: 10.1007/s10815-009-9299-5. Epub 2009 Feb 18.</citation>
    <PMID>19224360</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>December 23, 2016</last_update_submitted>
  <last_update_submitted_qc>December 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 26, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Osama Saber Thabet Abdalmageed</investigator_full_name>
    <investigator_title>Lecturer of OBGYN, Women Health Hospital, Assiut Univerisity</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</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/NCT03001492
org study id: Progesterone
nct id: NCT03001492
lead sponsor: 
has dmc: No
Elevation of serum progesterone on the day of ovulation triggering in IVF/ICSI cycles is
      suggested to be associated with compromized outcomes. Others found that this rise didnot
      affect the IVF/ICSI outcomes. It is still controversal if premature luteinization would
      affect the IVF/ICSI outcomes.
observational model: Cohort
time perspective: Prospective
measure: Clinical pregnacy rate
time frame: 14 days after the day of embryo transfer (ET)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: No
last name: Osama Abdalmageed
role: Principal Investigator
affiliation: Women health center
last name: Osama Abdalmageed
email: drosamast1981@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
citation: Sonmezer M, Pelin Cil A, Atabekoglu C, Ozkavukcu S, Ozmen B. Does premature luteinization or early surge of LH impair cycle outcome? Report of two successful outcomes. J Assist Reprod Genet. 2009 Mar;26(2-3):159-63. doi: 10.1007/s10815-009-9299-5. Epub 2009 Feb 18.
PMID: 19224360
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Osama Saber Thabet Abdalmageed
investigator title: Lecturer of OBGYN, Women Health Hospital, Assiut Univerisity
mesh term: Premature Birth