<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/NCT04455191</url>
  </required_header>
  <id_info>
    <org_study_id>JianCH-RM2020-001</org_study_id>
    <nct_id>NCT04455191</nct_id>
  </id_info>
  <brief_title>Comparison of Thawing Embryos in Advance and on the Day of Transfer on Pregnancy Outcomes in FET Cycle</brief_title>
  <official_title>Comparison of the Effects of Thawing Embryos in Advance and Thawing on the Day of Transfer on Pregnancy Outcomes in the Frozen Embryo Transfer Cycle</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jinan Central Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jinan Central Hospital</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>
      Respectively for patients with repeated transplant failure and routine patients, Thawing&#xD;
      frozen embryos in advance (18h) to extend the duration of embryonic development or thawing&#xD;
      embryos on the day of transfer in the frozen embryo transfer cycle, to analyze which way can&#xD;
      improve clinical pregnancy outcomes, is there a significant difference between the two ways&#xD;
      or two types of patients?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although in clinical practice, thawed embryos with appropriate development time will be&#xD;
      selected strictly according to the number of days after ovulation, there are still two&#xD;
      problems in actual clinical treatment: one is the embryonic factor, although the rate of&#xD;
      embryonic development is generally the same, However, the phenomenon of delayed embryo&#xD;
      division and development often occurs. The second is the endometrial factor. There are&#xD;
      reports that a small number of people will move the transplant window forward, or the&#xD;
      transplant window is narrow. This potentially creates the risk of embryo-endometrial&#xD;
      mismatch. Based on this, the research team focused on patients with frozen embryo transfer&#xD;
      cycles and put forward the strategy of &quot;thawing embryos in advance and prolonging the&#xD;
      development period of embryos properly&quot; in an effort to achieve better repair of damage&#xD;
      caused by embryo freezing and fine-tuning of embryo-endometrial interaction time. Therefore,&#xD;
      it is necessary to compare thawing embryos in advance and thawing on the day of transfer on&#xD;
      pregnancy outcomes in patients with repeated transplant failure and routine patients&#xD;
      respectively.&#xD;
&#xD;
      The purpose of this study is to analyze which way can improve clinical pregnancy and birth&#xD;
      outcomes, is there a significant difference between the two ways or two types of patients?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2021</primary_completion_date>
  <phase>N/A</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>Screening</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical Pregnancy Rate (Pregnancy or Not)</measure>
    <time_frame>6 weeks</time_frame>
    <description>Observe the clinical pregnancy rate under different embryo thawing time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Live Birth Rate (Birth or Not)</measure>
    <time_frame>40 weeks</time_frame>
    <description>Observe the live birth rate under different embryo thawing time</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>In Vitro Fertilization</condition>
  <condition>Frozen Embryo Transfer</condition>
  <arm_group>
    <arm_group_label>Thawing Embryos in Advance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thawing embryos one day in advance (16:00), 18h before embryos transfer (10:00).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Thawing Embryos on the Day of Transfer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thawing embryos on the day of transfer (8:00), 2h before embryos transfer (10:00).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thawing Embryos in Advance</intervention_name>
    <description>Thaw Embryos one day in Advance</description>
    <arm_group_label>Thawing Embryos in Advance</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thawing Embryos on the Day of Transfer</intervention_name>
    <description>Thaw Embryos on the morning of transfer day.</description>
    <arm_group_label>Thawing Embryos on the Day of Transfer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged &lt;=35 years old;&#xD;
&#xD;
          -  Regular menstrual cycle;&#xD;
&#xD;
          -  Baseline follicle stimulating hormone (FSH) &lt;12 IU/L;&#xD;
&#xD;
          -  Infertility, pure fallopian tube or/and male factor;&#xD;
&#xD;
          -  At least 2 high-quality day 3 embryos or 1 high-quality day 5 blastocyst are used for&#xD;
             ET.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with repeated transplant failure:&#xD;
&#xD;
          -  Abnormal uterus, such as adenomyosis, endometriosis, endometrial polyps or Asherman&#xD;
             syndrome;&#xD;
&#xD;
          -  Abnormal ovaries, such as low ovarian response and polycystic ovary syndrome (PCOS);&#xD;
&#xD;
          -  The endometrial thickness of FET day is &lt;7 mm.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women in childbearing age intend to do IVF-FET</gender_description>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yingchun Zhang, Dr</last_name>
    <role>Study Director</role>
    <affiliation>Jinan Central Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jinan Central Hospital Affiliated to Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Jinan Central Hospital</investigator_affiliation>
    <investigator_full_name>Bin Wu</investigator_full_name>
    <investigator_title>Reproductive medicine department</investigator_title>
  </responsible_party>
  <keyword>Frozen embryos</keyword>
  <keyword>Thawing</keyword>
  <!-- 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/NCT04455191
org study id: JianCH-RM2020-001
nct id: NCT04455191
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Respectively for patients with repeated transplant failure and routine patients, Thawing
      frozen embryos in advance (18h) to extend the duration of embryonic development or thawing
      embryos on the day of transfer in the frozen embryo transfer cycle, to analyze which way can
      improve clinical pregnancy outcomes, is there a significant difference between the two ways
      or two types of patients?
Although in clinical practice, thawed embryos with appropriate development time will be
      selected strictly according to the number of days after ovulation, there are still two
      problems in actual clinical treatment: one is the embryonic factor, although the rate of
      embryonic development is generally the same, However, the phenomenon of delayed embryo
      division and development often occurs. The second is the endometrial factor. There are
      reports that a small number of people will move the transplant window forward, or the
      transplant window is narrow. This potentially creates the risk of embryo-endometrial
      mismatch. Based on this, the research team focused on patients with frozen embryo transfer
      cycles and put forward the strategy of "thawing embryos in advance and prolonging the
      development period of embryos properly" in an effort to achieve better repair of damage
      caused by embryo freezing and fine-tuning of embryo-endometrial interaction time. Therefore,
      it is necessary to compare thawing embryos in advance and thawing on the day of transfer on
      pregnancy outcomes in patients with repeated transplant failure and routine patients
      respectively.

      The purpose of this study is to analyze which way can improve clinical pregnancy and birth
      outcomes, is there a significant difference between the two ways or two types of patients?
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Participant)
measure: Clinical Pregnancy Rate (Pregnancy or Not)
time frame: 6 weeks
description: Observe the clinical pregnancy rate under different embryo thawing time
measure: Live Birth Rate (Birth or Not)
time frame: 40 weeks
description: Observe the live birth rate under different embryo thawing time
arm group label: Thawing Embryos in Advance
arm group type: Experimental
description: Thawing embryos one day in advance (16:00), 18h before embryos transfer (10:00).
arm group label: Thawing Embryos on the Day of Transfer
arm group type: Experimental
description: Thawing embryos on the day of transfer (8:00), 2h before embryos transfer (10:00).
intervention type: Procedure
intervention name: Thawing Embryos in Advance
description: Thaw Embryos one day in Advance
arm group label: Thawing Embryos in Advance
intervention type: Procedure
intervention name: Thawing Embryos on the Day of Transfer
description: Thaw Embryos on the morning of transfer day.
arm group label: Thawing Embryos on the Day of Transfer
criteria: 
gender: Female
gender based: Yes
gender description: Women in childbearing age intend to do IVF-FET
minimum age: 25 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yingchun Zhang, Dr
role: Study Director
affiliation: Jinan Central Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Jinan Central Hospital
investigator full name: Bin Wu
investigator title: Reproductive medicine department