<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/NCT03763786</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS 243105</org_study_id>
    <secondary_id>2018-001915-63</secondary_id>
    <nct_id>NCT03763786</nct_id>
  </id_info>
  <brief_title>Frozen Embryo Transfer With GnRH-antagonist Trial</brief_title>
  <official_title>A Randomised Controlled Pilot Trial of the Use of GnRH-antagonist Pituitary Suppression During Medicated Frozen-thawed Embryo Transfer (FET) Cycles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oxford</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Oxford Fertility Limited, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Oxford</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The fertility treatment in vitro fertilisation (IVF), sometimes including intra-cytoplasmic&#xD;
      sperm injection (ICSI), involves the creation of embryos in a laboratory. These embryos are&#xD;
      then transferred into the womb of the patient with the hope of a resulting pregnancy and live&#xD;
      birth. Embryos can also be cryopreserved (frozen) and stored, and then later replaced in a&#xD;
      cycle called frozen embryo transfer (FET). There are several methods of preparing the&#xD;
      patient's womb to receive the frozen-thawed embryo(s) but commonly embryos are replaced&#xD;
      during a medicated cycle. Usually oestrogen and progesterone are administered to prepare the&#xD;
      womb lining for embryo transfer at the appropriate time, and in addition a drug called a GnRH&#xD;
      antagonist is administered to prevent a women's own hormones from interfering with this&#xD;
      process as it is thought this might lead to higher numbers of cycles being cancelled.&#xD;
      However, there is some suspicion that this drug (GnRH antagonist) may not be required and&#xD;
      that women are using this drug unnecessarily.&#xD;
&#xD;
      Some clinics do not use GnRH antagonists in FET cycles, but the investigators do not know if&#xD;
      they have higher rates of cancelled cycles as a result.&#xD;
&#xD;
      This pilot study aims to compare cycles of medicated FET using oestrogen and progesterone,&#xD;
      either with or without pituitary suppression in the form of GnRH antagonist (Cetrotide), in&#xD;
      patients over the next 18 months who are planning FET cycles at Oxford Fertility, UK to find&#xD;
      out if both give the same chance of having a baby, which treatment is better for patients and&#xD;
      to assess the feasibility of undertaking a future larger study. Cetrotide is a marketed and&#xD;
      well-known medication and any risk or serious adverse effects are unlikely. The study is an&#xD;
      open label prospective randomised controlled trial. Funding for the medication (Cetrotide) is&#xD;
      provided by Oxford Fertility.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</primary_completion_date>
  <phase>Phase 4</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>To treatment or pregnancy end (up to 9 months)</time_frame>
    <description>Livebirth rate per FET treatment cycle</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cancellation rate</measure>
    <time_frame>Through study completion (18 months)</time_frame>
    <description>Number of cycles cancelled over number of treatment cycles started</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Clinical Pregnancy Rate</measure>
    <time_frame>To treatment or pregnancy end (up to 9 months)</time_frame>
    <description>Defined as number of intrauterine pregnancies with at least one fetal heart visible on an early pregnancy ultrasound scan per treatment cycle.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>No GnRH antaogonist</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cetrorelix Acetate (NOT given) Daily 0.25mg Subcutaneous injection for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard GnRH antoagonist</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cetrorelix Acetate (control) Daily 0.25mg Subcutaneous injection for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cetrorelix Acetate</intervention_name>
    <description>Used a standard</description>
    <arm_group_label>No GnRH antaogonist</arm_group_label>
    <arm_group_label>Standard GnRH antoagonist</arm_group_label>
    <other_name>Cetrotide</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing and able to give informed consent for participation in the study.&#xD;
&#xD;
          -  Planning to undergo medicated FET&#xD;
&#xD;
          -  Blastocyst embryo in storage available for transfer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously randomised into the trial.&#xD;
&#xD;
          -  A history of 3 or more consecutive implantation failures (after fresh or frozen embryo&#xD;
             transfer).&#xD;
&#xD;
          -  A history of recurrent miscarriage (3 or more consecutive miscarriages).&#xD;
&#xD;
          -  Contraindication to the use of medications for FET cycle.&#xD;
&#xD;
          -  Biopsied embryos.&#xD;
&#xD;
          -  Donor embryos or eggs (use of donor sperm is not excluded).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Oxford Fertility</name>
      <address>
        <city>Oxford</city>
        <zip>OX4 2HW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>April 23, 2019</last_update_submitted>
  <last_update_submitted_qc>April 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Cetrorelix</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03763786
org study id: IRAS 243105
secondary id: 2018-001915-63
nct id: NCT03763786
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The fertility treatment in vitro fertilisation (IVF), sometimes including intra-cytoplasmic
      sperm injection (ICSI), involves the creation of embryos in a laboratory. These embryos are
      then transferred into the womb of the patient with the hope of a resulting pregnancy and live
      birth. Embryos can also be cryopreserved (frozen) and stored, and then later replaced in a
      cycle called frozen embryo transfer (FET). There are several methods of preparing the
      patient's womb to receive the frozen-thawed embryo(s) but commonly embryos are replaced
      during a medicated cycle. Usually oestrogen and progesterone are administered to prepare the
      womb lining for embryo transfer at the appropriate time, and in addition a drug called a GnRH
      antagonist is administered to prevent a women's own hormones from interfering with this
      process as it is thought this might lead to higher numbers of cycles being cancelled.
      However, there is some suspicion that this drug (GnRH antagonist) may not be required and
      that women are using this drug unnecessarily.

      Some clinics do not use GnRH antagonists in FET cycles, but the investigators do not know if
      they have higher rates of cancelled cycles as a result.

      This pilot study aims to compare cycles of medicated FET using oestrogen and progesterone,
      either with or without pituitary suppression in the form of GnRH antagonist (Cetrotide), in
      patients over the next 18 months who are planning FET cycles at Oxford Fertility, UK to find
      out if both give the same chance of having a baby, which treatment is better for patients and
      to assess the feasibility of undertaking a future larger study. Cetrotide is a marketed and
      well-known medication and any risk or serious adverse effects are unlikely. The study is an
      open label prospective randomised controlled trial. Funding for the medication (Cetrotide) is
      provided by Oxford Fertility.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Live Birth Rate
time frame: To treatment or pregnancy end (up to 9 months)
description: Livebirth rate per FET treatment cycle
measure: Cancellation rate
time frame: Through study completion (18 months)
description: Number of cycles cancelled over number of treatment cycles started
measure: Clinical Pregnancy Rate
time frame: To treatment or pregnancy end (up to 9 months)
description: Defined as number of intrauterine pregnancies with at least one fetal heart visible on an early pregnancy ultrasound scan per treatment cycle.
arm group label: No GnRH antaogonist
arm group type: Experimental
description: Cetrorelix Acetate (NOT given) Daily 0.25mg Subcutaneous injection for 7 days
arm group label: Standard GnRH antoagonist
arm group type: Active Comparator
description: Cetrorelix Acetate (control) Daily 0.25mg Subcutaneous injection for 7 days
intervention type: Drug
intervention name: Cetrorelix Acetate
description: Used a standard
arm group label: No GnRH antaogonist
arm group label: Standard GnRH antoagonist
other name: Cetrotide
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Infertility
mesh term: Cetrorelix
sharing ipd: No