xml: <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/NCT06006091</url>
    </required_header>
    <id_info>
      <org_study_id>InternationalPMCHH-1</org_study_id>
      <nct_id>NCT06006091</nct_id>
    </id_info>
    <brief_title>The Effectiveness of the Letrozole-induced Endometrial Preparation Protocol in Frozen-thawed Embryo Transfer (FET)</brief_title>
    <official_title>Clinical Outcomes of Letrozole-induced Endometrial Preparation Regimens Versus Conventional Endometrial Preparation Regimens Including Natural Cycle, Hormone Replacement Regimens in FET, a Randomized Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>International Peace Maternity and Child Health Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>International Peace Maternity and Child Health Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this single center, non-blinded, randomized controlled clinical trial to&#xD;
        comparison of pregnancy outcomes and perinatal outcomes in patients undergoing IVF treatment&#xD;
        (including ICSI) with FET with letrozole-induce endothelial preparation protocol versus&#xD;
        natural cycles, hormone replacement protocol.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  To investigate whether letrozole-induce endothelial preparation is effective in&#xD;
             improving the live birth rate and clinical pregnancy rate.&#xD;
  &#xD;
          -  To explore its possible impact on clinically important indicators such as spontaneous&#xD;
             abortion rate, implantation cycle cancellation rate, days of endothelial preparation,&#xD;
             and number of visits to the clinic.&#xD;
  &#xD;
        The study subjects were randomized into groups starting at D1-D3 of the menstrual cycle. The&#xD;
        study subjects were stratified according to whether their menstrual cycles were regular or&#xD;
        not, and were divided into the following endothelial preparation regimens according to the&#xD;
        pre-prepared stratified zoned randomized group numbers: (1) regular menstrual cycles (25-35&#xD;
        d): letrozole ovulation-promoting cycles, natural cycles, and hormone-replacement cycles; and&#xD;
        (2) irregular menstrual cycles (&lt;25 d or &gt;35 d): letrozole ovulation-promoting cycles,&#xD;
        hormone-replacement cycle.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2026</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Live birth</measure>
      <time_frame>40-42 weeks'estimated gestational age</time_frame>
      <description>The number of deliveries resulting in at least one live birth</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Clinical pregnancy</measure>
      <time_frame>5-7 weeks' estimated gestational age</time_frame>
      <description>Clinical pregnancies diagnosed by ultrasonographic visualisation of gestational sacs, the number of clinical pregnancies expressed per 100 embryo transfer cycles</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>embryo implantation</measure>
      <time_frame>14 day after embryo transfer</time_frame>
      <description>Serum Human Chorionic Gonadotropin levels &gt;10 IU/L, the number of gestational sacs observed divided by the number of embryos transferred</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">858</enrollment>
    <condition>Letrozole</condition>
    <condition>Infertility, Female</condition>
    <arm_group>
      <arm_group_label>Letrozole-induced endometrial preparation protocol</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Starting at D3 of the menstrual cycle, letrozole 2.5 mg po qd was administered for 5 days. After 1 week, ultrasound was performed to dynamically monitor follicular development, and 75-150 IU im qd of human menopausal gonadotrophin (hMG) given to continue ovulation stimulation as needed, and oestradiol valerate 2 mg po qd was given to regulate endometrial thickness until the follicle developed to 16 mm in diameter and 7 mm in endometrial thickness. The follicles developed to ≥16 mm in diameter and ≥7 mm in lining thickness and were dynamically monitored by ultrasound and serum sex hormone levels to determine the day of ovulation. From the day of ovulation, dexamethasone 10 mg po tid was administered, and cleavage-stage embryos were transferred 2 or 3 days later, or blastocysts were transferred 5 days later. Deferiprone 10 mg po tid was continued for 14 days after transfer.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Natural cycles endometrial preparation protocol</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Follicular development was monitored dynamically by ultrasound from D8-D11of the menstrual cycle until the follicles developed to ≥16 mm in diameter and ≥7 mm in endothelial thickness, and the day of ovulation was determined by dynamic ultrasound monitoring and detection of serum sex hormone levels. Deferiprone 10 mg po tid was administered from the day of ovulation, and D2 or D3 cleavage stage embryos were transferred 2 or 3 days later, or blastocysts were transferred 5 days later. Deferiprone 10 mg po tid was continued for a total of 14 days after transfer. Cycles were canceled if endothelial thickness was &lt;7 mm on the day of ovulation or if serum progesterone levels were 5 nmol/L before ovulation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Hormone replacement cycles endometrial preparation protocol</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Starting from D1-D5 of the menstrual cycle, estradiol valerate 2 mg po bid was administered for 7 days, followed by ultrasound for dynamic monitoring of endothelial and follicular development, and if the endothelial thickness was &lt;7 mm, the dosage of estradiol valerate was increased to 3-4 mg po bid as appropriate. The number of days of hormone replacement ranged from 11-20 days, and when the endothelial thickness was 7 mm, luteinizing hormone vaginal slow-release gel 90 mg pv qd was added, as well as dexedrine and progesterone 10 mg po bid to transform the endothelium 2 or 3 days later or 5 days later. Progesterone 10 mg po bid was added to transform the endothelium, and cleavage stage embryos were transferred 2 or 3 days later, or blastocysts were transferred 5 days later. Luteal support as described above was continued for a total of 14 days after transfer.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Letrozole</intervention_name>
      <description>Different endothelial preparations according to groups, see arm descriptions for details</description>
      <arm_group_label>Letrozole-induced endometrial preparation protocol</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Women &lt;40 years of age undergoing IVF or ICSI at our reproductive center with a total of ≤3&#xD;
          superovulation cycles , and with ≥2 cleavage embryos or ≥1 blastocyst were cryopreserved.&#xD;
          Previous cycles of embryo transfer ≤ 2 and only one transfer cycle with 1-2 embryos per&#xD;
          study subject was enrolled.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with chromosomal abnormalities in either spouse, hydrosalpinx, severe&#xD;
               endometriosis, adenomyosis, and uterine and uterine cavity organic diseases such as&#xD;
               uterine malformations, endometrial polyps, and uterine adhesions;&#xD;
  &#xD;
            2. patients who underwent pre-implantation genetic diagnosis (PGT);&#xD;
  &#xD;
            3. patients who underwent ICSI using surgically obtained epididymal or testicular&#xD;
               spermatozoa;&#xD;
  &#xD;
            4. patients with a Body mass index (BMI, = weight/height2 ) &gt; 30 kg/m2;&#xD;
  &#xD;
            5. patients with recurrent spontaneous abortions;&#xD;
  &#xD;
            6. patients with sequential embryo transfer.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>As this was an assisted reproduction-related study, the population included was physiologically (with uterus and ovaries) and genetically (with XX sex chromosomes) female.</gender_description>
      <minimum_age>N/A</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Chengliang Zhou, Dr.</last_name>
      <phone>08613758240793</phone>
      <email>chengliang_zhou@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xiaojun Chen, Dr.</last_name>
      <phone>19921917097</phone>
      <email>cxj8012@hotmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Yu Xiao</name>
        <address>
          <city>Shanghai</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yu Xiao, Dr.</last_name>
        <email>ethanhsiao@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>International Peace Maternity and Child Health Hospital</investigator_affiliation>
      <investigator_full_name>Chenliang Zhou</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <keyword>Frozen-thawed embryo transfer</keyword>
    <keyword>Letroziole</keyword>
    <keyword>Endothelial preparation protocol</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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Letrozole</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06006091
  org study id: InternationalPMCHH-1
  nct id: NCT06006091
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this single center, non-blinded, randomized controlled clinical trial to
        comparison of pregnancy outcomes and perinatal outcomes in patients undergoing IVF treatment
        (including ICSI) with FET with letrozole-induce endothelial preparation protocol versus
        natural cycles, hormone replacement protocol.
  
        The main questions it aims to answer are:
  
          -  To investigate whether letrozole-induce endothelial preparation is effective in
             improving the live birth rate and clinical pregnancy rate.
  
          -  To explore its possible impact on clinically important indicators such as spontaneous
             abortion rate, implantation cycle cancellation rate, days of endothelial preparation,
             and number of visits to the clinic.
  
        The study subjects were randomized into groups starting at D1-D3 of the menstrual cycle. The
        study subjects were stratified according to whether their menstrual cycles were regular or
        not, and were divided into the following endothelial preparation regimens according to the
        pre-prepared stratified zoned randomized group numbers: (1) regular menstrual cycles (25-35
        d): letrozole ovulation-promoting cycles, natural cycles, and hormone-replacement cycles; and
        (2) irregular menstrual cycles (<25 d or >35 d): letrozole ovulation-promoting cycles,
        hormone-replacement cycle.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Live birth
  time frame: 40-42 weeks'estimated gestational age
  description: The number of deliveries resulting in at least one live birth
  measure: Clinical pregnancy
  time frame: 5-7 weeks' estimated gestational age
  description: Clinical pregnancies diagnosed by ultrasonographic visualisation of gestational sacs, the number of clinical pregnancies expressed per 100 embryo transfer cycles
  measure: embryo implantation
  time frame: 14 day after embryo transfer
  description: Serum Human Chorionic Gonadotropin levels >10 IU/L, the number of gestational sacs observed divided by the number of embryos transferred
  arm group label: Letrozole-induced endometrial preparation protocol
  arm group type: Experimental
  description: Starting at D3 of the menstrual cycle, letrozole 2.5 mg po qd was administered for 5 days. After 1 week, ultrasound was performed to dynamically monitor follicular development, and 75-150 IU im qd of human menopausal gonadotrophin (hMG) given to continue ovulation stimulation as needed, and oestradiol valerate 2 mg po qd was given to regulate endometrial thickness until the follicle developed to 16 mm in diameter and 7 mm in endometrial thickness. The follicles developed to ≥16 mm in diameter and ≥7 mm in lining thickness and were dynamically monitored by ultrasound and serum sex hormone levels to determine the day of ovulation. From the day of ovulation, dexamethasone 10 mg po tid was administered, and cleavage-stage embryos were transferred 2 or 3 days later, or blastocysts were transferred 5 days later. Deferiprone 10 mg po tid was continued for 14 days after transfer.
  arm group label: Natural cycles endometrial preparation protocol
  arm group type: No Intervention
  description: Follicular development was monitored dynamically by ultrasound from D8-D11of the menstrual cycle until the follicles developed to ≥16 mm in diameter and ≥7 mm in endothelial thickness, and the day of ovulation was determined by dynamic ultrasound monitoring and detection of serum sex hormone levels. Deferiprone 10 mg po tid was administered from the day of ovulation, and D2 or D3 cleavage stage embryos were transferred 2 or 3 days later, or blastocysts were transferred 5 days later. Deferiprone 10 mg po tid was continued for a total of 14 days after transfer. Cycles were canceled if endothelial thickness was <7 mm on the day of ovulation or if serum progesterone levels were 5 nmol/L before ovulation.
  arm group label: Hormone replacement cycles endometrial preparation protocol
  arm group type: No Intervention
  description: Starting from D1-D5 of the menstrual cycle, estradiol valerate 2 mg po bid was administered for 7 days, followed by ultrasound for dynamic monitoring of endothelial and follicular development, and if the endothelial thickness was <7 mm, the dosage of estradiol valerate was increased to 3-4 mg po bid as appropriate. The number of days of hormone replacement ranged from 11-20 days, and when the endothelial thickness was 7 mm, luteinizing hormone vaginal slow-release gel 90 mg pv qd was added, as well as dexedrine and progesterone 10 mg po bid to transform the endothelium 2 or 3 days later or 5 days later. Progesterone 10 mg po bid was added to transform the endothelium, and cleavage stage embryos were transferred 2 or 3 days later, or blastocysts were transferred 5 days later. Luteal support as described above was continued for a total of 14 days after transfer.
  intervention type: Drug
  intervention name: Letrozole
  description: Different endothelial preparations according to groups, see arm descriptions for details
  arm group label: Letrozole-induced endometrial preparation protocol
  criteria: 
  gender: Female
  gender based: Yes
  gender description: As this was an assisted reproduction-related study, the population included was physiologically (with uterus and ovaries) and genetically (with XX sex chromosomes) female.
  minimum age: N/A
  maximum age: 40 Years
  healthy volunteers: No
  last name: Chengliang Zhou, Dr.
  phone: 08613758240793
  email: chengliang_zhou@163.com
  last name: Xiaojun Chen, Dr.
  phone: 19921917097
  email: cxj8012@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: International Peace Maternity and Child Health Hospital
  investigator full name: Chenliang Zhou
  investigator title: Director
  mesh term: Infertility
  mesh term: Infertility, Female
  mesh term: Letrozole