<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/NCT03040830</url>
  </required_header>
  <id_info>
    <org_study_id>P4 luteal support and ET</org_study_id>
    <nct_id>NCT03040830</nct_id>
  </id_info>
  <brief_title>Effect of Timing Progesterone Luteal Support on Embryo Transfer</brief_title>
  <official_title>Does the Time of Starting Progesterone (P4) Luteal Support (LS) Affects Embryo Transfer (ET) in Long Agonist Protocol Down-regulated ICSI Cycles?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura Integrated Fertility Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura Integrated Fertility Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to know whether starting progesterone luteal support in intra cytoplasmic&#xD;
      sperm injection (ICSI) cycles on the day of ovum pickup affects the degree of difficulty of&#xD;
      embryo transfer compared with starting luteal support on day of embryo transfer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Double blind Randomized Controlled Trial (RCT) : the clinicians and the patents were blinded&#xD;
      of the allocation group.&#xD;
&#xD;
      A total of 137 embryo transfers were randomly allocated into either arm I (67 ) starting&#xD;
      luteal support as daily IM injections of 100 mg prontogest on day of egg retrieval , or arm&#xD;
      II (66) starting the same P4 dose on day of embryo transfer&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2015</start_date>
  <completion_date type="Actual">January 1, 2017</completion_date>
  <primary_completion_date type="Actual">October 30, 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Double blind Randomized Controlled Trial : the clinicians and the patents were blinded of the allocation group.&#xD;
A total of 137 embryo transfers (ETs) were randomly allocated into either group A (67 ) starting luteal support as daily intra muscular (IM) injections of 100 mg prontogest on day of egg retrieval, or group B (66) starting the same P4 dose on day of embryo transfer.Transfer technique was blind tactile using Labotect catheter and was considered difficult if the inner ET catheter was blood stained and /or sounding or dilating the cervix was needed. Cervical traction or blood staining of outer sheath did not indicate difficulty</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
    <masking_description>The randomization</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>difficult embryo transfer</measure>
    <time_frame>3 minutes</time_frame>
    <description>presence of blood on embryo transfer catheter and or need for sounding or dilating the cervix to pass the embryo transfer catheter to the endometrial cavity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cycle outcome</measure>
    <time_frame>4 weeks</time_frame>
    <description>clinical cycle pregnancy rate calculated as number of clinical pregnancies (gestational sacs shown by ultrasound ) per 100 cases transferred multiplied by 100.Implantation rate calculated by the outcome of dividing the total number of gestational sacs in the arm by the total number of embryos transferred.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Progesterone Luteal Support in ICSI</condition>
  <condition>Embryo Transfer</condition>
  <arm_group>
    <arm_group_label>Egg retrieval arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>67 ICSI cases are started daily 100 mg IM prontogest on the day of egg retrieval until the day of pregnancy test.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Embryo transfer arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>66 ICSI cases are started daily 100 mg IM prontogest on the day of embryo transfer until the day of pregnancy test.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Progesterone 100 IM/day</intervention_name>
    <description>Progesterone IM 100 mg /day was started on day of egg retrieval in egg retrieval arm and on day of embryo transfer in the embryo transfer arm</description>
    <arm_group_label>Egg retrieval arm</arm_group_label>
    <arm_group_label>Embryo transfer arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first ICSI trial, normal uterus, normal cervix, normal ovarian response ,easy mock&#xD;
             transfer,patient consenting&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age over 38, difficult mock transfer, low and high ovarian response, patient not&#xD;
             consenting&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>infertile females undergoing first ICSI cycle</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Mochtar MH, Van Wely M, Van der Veen F. Timing luteal phase support in GnRH agonist down-regulated IVF/embryo transfer cycles. Hum Reprod. 2006 Apr;21(4):905-8. doi: 10.1093/humrep/dei437. Epub 2005 Dec 22.</citation>
    <PMID>16373409</PMID>
  </reference>
  <reference>
    <citation>Senciboy D.N and Sharpe-Timms K.L: Progesterone affects the cervix prior to embryo transfer. , Fertility and Sterility ,2001: 76 , Issue 3 , S220 - S221</citation>
  </reference>
  <reference>
    <citation>Ghanem ME, Ragab AE, Alboghdady LA, Helal AS, Bedairy MH, Bahlol IA, Abdelaziz A. Difficult embryo transfer (ET) components and cycle outcome. Which is more harmful?. Middle East Fertility Society Journal. 2016 Jun 30;21(2):114-119</citation>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura Integrated Fertility Center</investigator_affiliation>
    <investigator_full_name>Mohamad Elsaid Ghanem</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Progesterone</mesh_term>
  </intervention_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/NCT03040830
org study id: P4 luteal support and ET
nct id: NCT03040830
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study aims to know whether starting progesterone luteal support in intra cytoplasmic
      sperm injection (ICSI) cycles on the day of ovum pickup affects the degree of difficulty of
      embryo transfer compared with starting luteal support on day of embryo transfer
Double blind Randomized Controlled Trial (RCT) : the clinicians and the patents were blinded
      of the allocation group.

      A total of 137 embryo transfers were randomly allocated into either arm I (67 ) starting
      luteal support as daily IM injections of 100 mg prontogest on day of egg retrieval , or arm
      II (66) starting the same P4 dose on day of embryo transfer
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double blind Randomized Controlled Trial : the clinicians and the patents were blinded of the allocation group.
A total of 137 embryo transfers (ETs) were randomly allocated into either group A (67 ) starting luteal support as daily intra muscular (IM) injections of 100 mg prontogest on day of egg retrieval, or group B (66) starting the same P4 dose on day of embryo transfer.Transfer technique was blind tactile using Labotect catheter and was considered difficult if the inner ET catheter was blood stained and /or sounding or dilating the cervix was needed. Cervical traction or blood staining of outer sheath did not indicate difficulty
primary purpose: Treatment
masking: Double (Participant, Care Provider)
masking description: The randomization
measure: difficult embryo transfer
time frame: 3 minutes
description: presence of blood on embryo transfer catheter and or need for sounding or dilating the cervix to pass the embryo transfer catheter to the endometrial cavity
measure: cycle outcome
time frame: 4 weeks
description: clinical cycle pregnancy rate calculated as number of clinical pregnancies (gestational sacs shown by ultrasound ) per 100 cases transferred multiplied by 100.Implantation rate calculated by the outcome of dividing the total number of gestational sacs in the arm by the total number of embryos transferred.
arm group label: Egg retrieval arm
arm group type: Experimental
description: 67 ICSI cases are started daily 100 mg IM prontogest on the day of egg retrieval until the day of pregnancy test.
arm group label: Embryo transfer arm
arm group type: Active Comparator
description: 66 ICSI cases are started daily 100 mg IM prontogest on the day of embryo transfer until the day of pregnancy test.
intervention type: Drug
intervention name: Progesterone 100 IM/day
description: Progesterone IM 100 mg /day was started on day of egg retrieval in egg retrieval arm and on day of embryo transfer in the embryo transfer arm
arm group label: Egg retrieval arm
arm group label: Embryo transfer arm
criteria: 
gender: Female
gender based: Yes
gender description: infertile females undergoing first ICSI cycle
minimum age: 18 Years
maximum age: 38 Years
healthy volunteers: No
citation: Mochtar MH, Van Wely M, Van der Veen F. Timing luteal phase support in GnRH agonist down-regulated IVF/embryo transfer cycles. Hum Reprod. 2006 Apr;21(4):905-8. doi: 10.1093/humrep/dei437. Epub 2005 Dec 22.
PMID: 16373409
citation: Senciboy D.N and Sharpe-Timms K.L: Progesterone affects the cervix prior to embryo transfer. , Fertility and Sterility ,2001: 76 , Issue 3 , S220 - S221
citation: Ghanem ME, Ragab AE, Alboghdady LA, Helal AS, Bedairy MH, Bahlol IA, Abdelaziz A. Difficult embryo transfer (ET) components and cycle outcome. Which is more harmful?. Middle East Fertility Society Journal. 2016 Jun 30;21(2):114-119
responsible party type: Principal Investigator
investigator affiliation: Mansoura Integrated Fertility Center
investigator full name: Mohamad Elsaid Ghanem
investigator title: Professor
mesh term: Progesterone