<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/NCT03788681</url>
  </required_header>
  <id_info>
    <org_study_id>Ain Shams Univ</org_study_id>
    <nct_id>NCT03788681</nct_id>
  </id_info>
  <brief_title>Luteal Phase Support With Estradiol In Poor Responders Undergoing In Vitro Fertilization</brief_title>
  <official_title>Luteal Phase Support With Estradiol In Poor Responders Undergoing In Vitro Fertilization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</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 role of progesterone (P) supplementation in the luteal phase of in vitro fertilization&#xD;
      (IVF) cycles is well established world-wide , but the influence of the luteal phase estradiol&#xD;
      level on implantation is not clearly defined . There is a significant difference in estradiol&#xD;
      levels between fertile and infertile cycles of fertile women who underwent donor&#xD;
      insemination.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Anticipated">September 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 1, 2019</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>live birth rate</measure>
    <time_frame>at least 28 weeks after ET</time_frame>
    <description>the number of deliveries that resulted in a live born neonate</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">170</enrollment>
  <condition>ICSI</condition>
  <arm_group>
    <arm_group_label>oral estradiol &quot; estradiol valerate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>this group will include ( 85 ) poor responder women undergoing a trial of IVF/ICSI .This group will receive oral estradiol &quot; estradiol valerate &quot; (Cyclo-Progynova® , 2mg , Bayer Schering Pharma Ag , Germany ) from within 24 hours ovum pickup of the cycle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>this group will include ( 85 ) poor responder women undergoing a trial of IVF/ICSI . This group will receive oral placebo (tablets) from within 24 hours ovum pickup of the cycle</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Estradiol Valerate</intervention_name>
    <description>oral estradiol &quot; estradiol valerate &quot; (Cyclo-Progynova)</description>
    <arm_group_label>oral estradiol &quot; estradiol valerate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>placebo</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants included in this study will have the following criteria : ( 2 of 3&#xD;
             criteria )&#xD;
&#xD;
               1. advanced maternal age or any other risk factor for POR :&#xD;
&#xD;
                    1. Age ≥35 years&#xD;
&#xD;
                    2. other risk factor of poor responder : ovarian surgery especially in case of&#xD;
                       endometrioma , chemotherapy, radiotherapy, autoimmune disorders, single&#xD;
                       ovary, chronic smoking, and unexplained Infertility.&#xD;
&#xD;
               2. previous poor ovarian response : Number of oocytes at the pickup time 3 or less .&#xD;
&#xD;
               3. Abnormal ovarian reserve tests :&#xD;
&#xD;
                    1. FSH ≥12 mIu/ml in the early follicular phase .&#xD;
&#xD;
                    2. Estradiol level more than 70 pg/dl in the early follicular phase&#xD;
&#xD;
                    3. Anti-Mullerian hormone (AMH) below 0.5-1.1 ng/ml.&#xD;
&#xD;
                    4. Antral follicle count (AFC) &lt; 5-7 follicles .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &gt;35 with good ovarian response .&#xD;
&#xD;
          2. any intra-uterine pathology can affect receptivity , ( for example ; Sub-mucosal&#xD;
             fibroid , intra-uterine adhesions ).&#xD;
&#xD;
          3. Severe male factor infertility.&#xD;
&#xD;
          4. Extended endometriosis (stage 3 or more) .&#xD;
&#xD;
          5. All contraindications for estradiol : venous thrombo-embolism , stroke and breast&#xD;
             cancer&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Radwa R Ali, MD</last_name>
    <phone>01283492979</phone>
    <phone_ext>02002</phone_ext>
    <email>radwaebed@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>AinShams university maternity hospital</name>
      <address>
        <city>Cairo</city>
        <state>Abbassya</state>
        <zip>11566</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mostafa f Gomaa, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>December 26, 2018</last_update_submitted>
  <last_update_submitted_qc>December 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Radwa Rasheedy Ali</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Estradiol 17 beta-cypionate</mesh_term>
    <mesh_term>Estradiol 3-benzoate</mesh_term>
    <mesh_term>Estradiol</mesh_term>
    <mesh_term>Polyestradiol phosphate</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/NCT03788681
org study id: Ain Shams Univ
nct id: NCT03788681
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The role of progesterone (P) supplementation in the luteal phase of in vitro fertilization
      (IVF) cycles is well established world-wide , but the influence of the luteal phase estradiol
      level on implantation is not clearly defined . There is a significant difference in estradiol
      levels between fertile and infertile cycles of fertile women who underwent donor
      insemination.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: live birth rate
time frame: at least 28 weeks after ET
description: the number of deliveries that resulted in a live born neonate
arm group label: oral estradiol " estradiol valerate
arm group type: Active Comparator
description: this group will include ( 85 ) poor responder women undergoing a trial of IVF/ICSI .This group will receive oral estradiol " estradiol valerate " (Cyclo-Progynova® , 2mg , Bayer Schering Pharma Ag , Germany ) from within 24 hours ovum pickup of the cycle.
arm group label: placebo
arm group type: Placebo Comparator
description: this group will include ( 85 ) poor responder women undergoing a trial of IVF/ICSI . This group will receive oral placebo (tablets) from within 24 hours ovum pickup of the cycle
intervention type: Drug
intervention name: Estradiol Valerate
description: oral estradiol " estradiol valerate " (Cyclo-Progynova)
arm group label: oral estradiol " estradiol valerate
intervention type: Drug
intervention name: Placebo Oral Tablet
description: placebo
arm group label: placebo
criteria: 
gender: Female
minimum age: 35 Years
maximum age: 44 Years
healthy volunteers: No
last name: Radwa R Ali, MD
phone: 01283492979
phone ext: 02002
email: radwaebed@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Radwa Rasheedy Ali
investigator title: Principal Investigator
mesh term: Estradiol 17 beta-cypionate
mesh term: Estradiol 3-benzoate
mesh term: Estradiol
mesh term: Polyestradiol phosphate