<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/NCT04408144</url>
  </required_header>
  <id_info>
    <org_study_id>0003-20-LND</org_study_id>
    <nct_id>NCT04408144</nct_id>
  </id_info>
  <brief_title>Addition of Dydrogesterone to the Luteal Phase Support After Fresh Embryo Transfer</brief_title>
  <official_title>Effectiveness of Treatment With Additional Dydrogesterone (Duphaston) to the Standard Luteal Phase Support After Fresh Embryo Transfer: a Prospective Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laniado Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laniado 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>
      Randomized controlled study, open label to compare effectiveness of addition of&#xD;
      dydrogesterone 20mg to the standard luteal phase support treatment after fresh embryos&#xD;
      transfer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the context of IVF treatment, it's a standard of care to use progesterone for endometrial&#xD;
      synchronization and for luteal phase support after embryos transfer and until week 9-12 of&#xD;
      pregnancy.&#xD;
&#xD;
      In Israel, as in most european countries, vaginal insert of Micronised Vaginal Progesterone&#xD;
      (MVP) is mostly prescribed.&#xD;
&#xD;
      Dydrogesterone is a potent active progesterone receptor agonist that is well tolerated,&#xD;
      orally administered and is considered to be sufficiently safe during pregnancy.&#xD;
&#xD;
      Based on recent publications, single oral dydrogesterone treatment seems to be a good option&#xD;
      in clinical practice for luteal phase support in IVF cycles with fresh embryos transfer.&#xD;
&#xD;
      But, until now, there is no publication evaluating the effectiveness of an addition of&#xD;
      Dydrogesterone to the standard of care.&#xD;
&#xD;
      The aim of the study is to compare effectiveness of addition of dydrogesterone 20mg to the&#xD;
      standard luteal phase support treatment after fresh embryos transfer.&#xD;
&#xD;
      The trial is a randomized controlled study, open label. Participants will receive either&#xD;
      standard treatment with an addition of oral 10mg dydrogesterone (Duphaston) 2 times daily or&#xD;
      the standard treatment without Dydrogesterone, starting on the day of fresh embryos transfer&#xD;
      until 10 weeks of gestation or until pregnancy test is negative.&#xD;
&#xD;
      Study participation will be proposed to every woman going through fresh embryos transfer in&#xD;
      Laniado IVF unit, who meets the inclusion/exclusion criteria.&#xD;
&#xD;
      The investigators aim to include 150 patients in each arm of the study, during 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">April 1, 2022</start_date>
  <completion_date type="Anticipated">May 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2022</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 rate</measure>
    <time_frame>9 month</time_frame>
    <description>The percentage of live newborns in the total cycles of treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Presence of fetal heartbeats at 12 weeks of gestation</measure>
    <time_frame>12 weeks</time_frame>
    <description>The percentage of pregnancies with heartbeats observed by ultrasound at 12 weeks in the total cycles of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of positive pregnancy tests on Day 14 after embryo transfer</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of obstetrical complications</measure>
    <time_frame>9 months</time_frame>
    <description>Obstetrical complications during pregnancy and labor. Examples- abruptio placenta, First trimester bleeding, Preterm Prelabor Rupture Of Membranes (PPROM), preterm labor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Newborn outcomes</measure>
    <time_frame>1 year</time_frame>
    <description>Appearance, Pulse, Grimace, Activity and Respiration (APGAR) score- between 0-10. 10 is the best outcome. 0 is the worst outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Newborn Weight</measure>
    <time_frame>9 months</time_frame>
    <description>in grammes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of Newborn malformations</measure>
    <time_frame>1 year</time_frame>
    <description>Abnormal findings of physical examination of the newborn</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>3 years</time_frame>
    <description>Adverse Events (AES) and Serious Adverse Events (SAES) will be recorded during all the study period</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Infertility</condition>
  <condition>IVF</condition>
  <arm_group>
    <arm_group_label>StudyGroup</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive an addition of dydrogesterone (Duphaston) to the standard treatment for luteal phase support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will receive the standard treatment for luteal phase support without Dydrogesterone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dydrogesterone 10mg Oral Tablet</intervention_name>
    <description>oral 10mg dydrogesterone (Duphaston) 2 times daily</description>
    <arm_group_label>StudyGroup</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a documented history of infertility who underwent IVF with or without&#xD;
             ICSI, going through embryos transfer (having in the past up to 2 previous embryos&#xD;
             transfer) and who gave written informed consent.&#xD;
&#xD;
          -  Body mass index ≥18 to ≤35 kg/m2&#xD;
&#xD;
          -  LH, prolactin (PRL), testosterone and thyroid-stimulating hormone (TSH) within normal&#xD;
             clinical limits or not considered clinically significant within 1 year prior to or at&#xD;
             screening&#xD;
&#xD;
          -  Normal transvaginal ultrasound at screening (or within 14 days prior to screening)&#xD;
&#xD;
          -  Planning a transfer of 1 or 2 fresh embryos.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous participation in this trial&#xD;
&#xD;
          -  Subjects with &gt;2 unsuccessful IVF attempts&#xD;
&#xD;
          -  Evidence of head, ear, eye, nose, throat, cardiovascular, respiratory, urogenital,&#xD;
             gastrointestinal/hepatic, hematologic/immunologic, dermatologic/connective tissue,&#xD;
             musculoskeletal, metabolic/nutritional, endocrine or neurologic/psychiatric disorders;&#xD;
&#xD;
          -  Recent major surgery (within 3 months);&#xD;
&#xD;
          -  Current or recent substance abuse, including that of alcohol and tobacco;&#xD;
&#xD;
          -  History of chemotherapy;&#xD;
&#xD;
          -  History of recurrent pregnancy loss (≥3 previous miscarriages)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Laniado Hospital</name>
      <address>
        <city>Netanya</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>May 12, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Laniado Hospital</investigator_affiliation>
    <investigator_full_name>Amir Weintraub</investigator_full_name>
    <investigator_title>Director, IVF Unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dydrogesterone</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/NCT04408144
org study id: 0003-20-LND
nct id: NCT04408144
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Randomized controlled study, open label to compare effectiveness of addition of
      dydrogesterone 20mg to the standard luteal phase support treatment after fresh embryos
      transfer.
In the context of IVF treatment, it's a standard of care to use progesterone for endometrial
      synchronization and for luteal phase support after embryos transfer and until week 9-12 of
      pregnancy.

      In Israel, as in most european countries, vaginal insert of Micronised Vaginal Progesterone
      (MVP) is mostly prescribed.

      Dydrogesterone is a potent active progesterone receptor agonist that is well tolerated,
      orally administered and is considered to be sufficiently safe during pregnancy.

      Based on recent publications, single oral dydrogesterone treatment seems to be a good option
      in clinical practice for luteal phase support in IVF cycles with fresh embryos transfer.

      But, until now, there is no publication evaluating the effectiveness of an addition of
      Dydrogesterone to the standard of care.

      The aim of the study is to compare effectiveness of addition of dydrogesterone 20mg to the
      standard luteal phase support treatment after fresh embryos transfer.

      The trial is a randomized controlled study, open label. Participants will receive either
      standard treatment with an addition of oral 10mg dydrogesterone (Duphaston) 2 times daily or
      the standard treatment without Dydrogesterone, starting on the day of fresh embryos transfer
      until 10 weeks of gestation or until pregnancy test is negative.

      Study participation will be proposed to every woman going through fresh embryos transfer in
      Laniado IVF unit, who meets the inclusion/exclusion criteria.

      The investigators aim to include 150 patients in each arm of the study, during 2 years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Live birth rate
time frame: 9 month
description: The percentage of live newborns in the total cycles of treatment
measure: Presence of fetal heartbeats at 12 weeks of gestation
time frame: 12 weeks
description: The percentage of pregnancies with heartbeats observed by ultrasound at 12 weeks in the total cycles of treatment
measure: Frequency of positive pregnancy tests on Day 14 after embryo transfer
time frame: 14 days
measure: Rates of obstetrical complications
time frame: 9 months
description: Obstetrical complications during pregnancy and labor. Examples- abruptio placenta, First trimester bleeding, Preterm Prelabor Rupture Of Membranes (PPROM), preterm labor
measure: Newborn outcomes
time frame: 1 year
description: Appearance, Pulse, Grimace, Activity and Respiration (APGAR) score- between 0-10. 10 is the best outcome. 0 is the worst outcome.
measure: Newborn Weight
time frame: 9 months
description: in grammes
measure: Rates of Newborn malformations
time frame: 1 year
description: Abnormal findings of physical examination of the newborn
measure: Incidence of Treatment-Emergent Adverse Events
time frame: 3 years
description: Adverse Events (AES) and Serious Adverse Events (SAES) will be recorded during all the study period
arm group label: StudyGroup
arm group type: Experimental
description: Patients will receive an addition of dydrogesterone (Duphaston) to the standard treatment for luteal phase support
arm group label: Control Group
arm group type: No Intervention
description: Patients will receive the standard treatment for luteal phase support without Dydrogesterone
intervention type: Drug
intervention name: Dydrogesterone 10mg Oral Tablet
description: oral 10mg dydrogesterone (Duphaston) 2 times daily
arm group label: StudyGroup
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Laniado Hospital
investigator full name: Amir Weintraub
investigator title: Director, IVF Unit
mesh term: Infertility
mesh term: Dydrogesterone