<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/NCT04485819</url>
  </required_header>
  <id_info>
    <org_study_id>MH0003</org_study_id>
    <nct_id>NCT04485819</nct_id>
  </id_info>
  <brief_title>Optimal Embryonic Stage for Transfer in Poor Responders</brief_title>
  <official_title>Achieving Better Clinical Outcomes With Blastocyt Transfer in Poor Responders: a Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ganin Fertility Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ganin 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>
      A Prospective cohort study including couples with poor responder females who undergoing ICSI&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose:&#xD;
&#xD;
      To determine the optimal embryonic stage for transfer in poor responders.&#xD;
&#xD;
      Method:&#xD;
&#xD;
      Patients were divided into day 3 transfer group and day 5 transfer group. All cases had the&#xD;
      same stimulation protocol and planning to do fresh embryo transfer. Assessments will be at&#xD;
      Day 1, Day 3 and Day 5/6 according to Gardner's criteria 1999. Embryological and clinical&#xD;
      data were recorded and then analyzed using SPSS (version 23) statistical software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">March 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2021</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>Live birth rate</measure>
    <time_frame>delivery of healthy neonate after 37 weeks of pregnancy</time_frame>
    <description>percentage of cycles started with the intent of egg retrieval that led to a live birth.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Implantation rate</measure>
    <time_frame>6 weeks of pregnancy</time_frame>
    <description>Percentage of the implanted embryos number for each group / number of transferred embryos.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>after 6 weeks of embryonic transfer</time_frame>
    <description>Percentage of pregnant cases with fetal heart / transferred cases for each group</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancellation rate</measure>
    <time_frame>5:6 days of ICSI</time_frame>
    <description>percentage of blast transfer cases who did not achieve blast stage (cancelled cases) / total number of blast stage cases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fertilization rate</measure>
    <time_frame>16:19 hours after intracytoplasmic injection(ICSI)</time_frame>
    <description>Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cleavage rate</measure>
    <time_frame>72 hours after ICSI</time_frame>
    <description>Percentage of cleaved embryos / Number of fertilized oocytes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High quality day 3 embryos</measure>
    <time_frame>72 hours after ICSI</time_frame>
    <description>High quality D3 embryos according to Gardner's criteria / total cleaved embryos</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blast rate</measure>
    <time_frame>5:6 days of ICSI</time_frame>
    <description>Percentage of total blastocysts / Total cleaved embryos</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High quality blast rate</measure>
    <time_frame>5:6 days of ICSI</time_frame>
    <description>Morphological grading of trophectoderm and Inner cell mass using Gardner's criteria 1999, from grade A and B ( A is the highest quality). Total high grade embryos/ total blast embryos.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Poor Response to Ovulation Induction</condition>
  <condition>Infertility, Female</condition>
  <arm_group>
    <arm_group_label>Cleavage stage transfer</arm_group_label>
    <description>Poor responders who transfer their embryos in cleavage stage on day 3</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Blast stage transfer</arm_group_label>
    <description>Poor responders who transfer their embryos on blast stage on day 5/6</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cleavage stage transfer</intervention_name>
    <description>transferring embryos through ICSI procedures for poor responders on cleavage stage of embryonic development.</description>
    <arm_group_label>Cleavage stage transfer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blast stage transfer</intervention_name>
    <description>transferring embryos through ICSI procedures for poor responders on blast stage of embryonic development.</description>
    <arm_group_label>Blast stage transfer</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Poor responders undergoing ICSI procedures at Ganin fertility center in Egypt&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  poor responders females with AMH≤ 1.2ng and have ≤ 5 mature oocytes&#xD;
&#xD;
          -  couples whose planning to do fresh transfer&#xD;
&#xD;
          -  male partners have normal semen parameters according to WHO 2010.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  sperm or oocyte donation&#xD;
&#xD;
          -  gestational carriers&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>poor responders females with AMH≤ 1.2ng and have ≤ 5 mature oocytes</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manar Hozyen, MSc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ganin Fertility Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amira Hassan, BSc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ganin Fertility Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hanaa Elkhader, BSc.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ganin Fertility Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hosam Zaki</last_name>
    <role>Study Chair</role>
    <affiliation>Ganin Fertility Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Manar M Hozyen, MSc.</last_name>
    <phone>+2001229483320</phone>
    <email>manarnrc@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amira Hassan, BSc.</last_name>
    <email>manarnrc@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ganin fertility center</name>
      <address>
        <city>Cairo</city>
        <zip>11728</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Poor responders</keyword>
  <keyword>Embryo transfer</keyword>
  <keyword>Cancellation rate</keyword>
  <keyword>Implantation rate</keyword>
  <keyword>Live birth rate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</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/NCT04485819
org study id: MH0003
nct id: NCT04485819
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A Prospective cohort study including couples with poor responder females who undergoing ICSI
Purpose:

      To determine the optimal embryonic stage for transfer in poor responders.

      Method:

      Patients were divided into day 3 transfer group and day 5 transfer group. All cases had the
      same stimulation protocol and planning to do fresh embryo transfer. Assessments will be at
      Day 1, Day 3 and Day 5/6 according to Gardner's criteria 1999. Embryological and clinical
      data were recorded and then analyzed using SPSS (version 23) statistical software.
observational model: Cohort
time perspective: Prospective
measure: Live birth rate
time frame: delivery of healthy neonate after 37 weeks of pregnancy
description: percentage of cycles started with the intent of egg retrieval that led to a live birth.
measure: Implantation rate
time frame: 6 weeks of pregnancy
description: Percentage of the implanted embryos number for each group / number of transferred embryos.
measure: Clinical pregnancy rate
time frame: after 6 weeks of embryonic transfer
description: Percentage of pregnant cases with fetal heart / transferred cases for each group
measure: Cancellation rate
time frame: 5:6 days of ICSI
description: percentage of blast transfer cases who did not achieve blast stage (cancelled cases) / total number of blast stage cases
measure: Fertilization rate
time frame: 16:19 hours after intracytoplasmic injection(ICSI)
description: Percentage of fertilized oocyte (appearance of two pronuclei) / Number of injected oocytes
measure: Cleavage rate
time frame: 72 hours after ICSI
description: Percentage of cleaved embryos / Number of fertilized oocytes
measure: High quality day 3 embryos
time frame: 72 hours after ICSI
description: High quality D3 embryos according to Gardner's criteria / total cleaved embryos
measure: Blast rate
time frame: 5:6 days of ICSI
description: Percentage of total blastocysts / Total cleaved embryos
measure: High quality blast rate
time frame: 5:6 days of ICSI
description: Morphological grading of trophectoderm and Inner cell mass using Gardner's criteria 1999, from grade A and B ( A is the highest quality). Total high grade embryos/ total blast embryos.
arm group label: Cleavage stage transfer
description: Poor responders who transfer their embryos in cleavage stage on day 3
arm group label: Blast stage transfer
description: Poor responders who transfer their embryos on blast stage on day 5/6
intervention type: Other
intervention name: Cleavage stage transfer
description: transferring embryos through ICSI procedures for poor responders on cleavage stage of embryonic development.
arm group label: Cleavage stage transfer
intervention type: Other
intervention name: Blast stage transfer
description: transferring embryos through ICSI procedures for poor responders on blast stage of embryonic development.
arm group label: Blast stage transfer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: poor responders females with AMH≤ 1.2ng and have ≤ 5 mature oocytes
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Manar Hozyen, MSc.
role: Principal Investigator
affiliation: Ganin Fertility Center
last name: Amira Hassan, BSc.
role: Principal Investigator
affiliation: Ganin Fertility Center
last name: Hanaa Elkhader, BSc.
role: Principal Investigator
affiliation: Ganin Fertility Center
last name: Hosam Zaki
role: Study Chair
affiliation: Ganin Fertility Center
last name: Manar M Hozyen, MSc.
phone: +2001229483320
email: manarnrc@gmail.com
last name: Amira Hassan, BSc.
email: manarnrc@gmail.com
facility: 
status: Recruiting
country: Egypt
responsible party type: Sponsor
mesh term: Infertility
mesh term: Infertility, Female