<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/NCT03300960</url>
  </required_header>
  <id_info>
    <org_study_id>1705-VLC-030-JG</org_study_id>
    <nct_id>NCT03300960</nct_id>
  </id_info>
  <brief_title>Usefulness of Medroxyprogesterone Acetate in Follicular Phase in Oocyte Donors. Undergoing Ovarian Stimulation</brief_title>
  <official_title>Usefulness of Medroxyprogesterone Acetate in Follicular Phase in Oocyte Donors.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Valenciano de Infertilidad, IVI VALENCIA</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Valenciano de Infertilidad, IVI VALENCIA</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to determine whether Medroxyprogesterone Acetate (MPA)&#xD;
      administration in follicular phase prevents premature luteinization with equal efficiency as&#xD;
      GnRH antagonists and otains similar clinical results in oocyte donation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Within the new guidelines for stimulation, the use of oral progesterone in follicular phase&#xD;
      allows GnRH analogue administration, resulting in greater comfort for patients as well as a&#xD;
      reduction in cost. Obtained results are similar to those from conventional protocols in terms&#xD;
      of: early luteinization, number of oocytes, embryos number and rate of implantation and&#xD;
      gestation or appearance of congenital malformations. Another advantage is the lower incidence&#xD;
      of OHSS (Ovarian Hyperstimulation Syndrome).&#xD;
&#xD;
      From a scientific point of view, it would allow a better understanding of folliculogenesis,&#xD;
      of progesterone mechanism of action on blocking LH secretion and its effect on ovarian and&#xD;
      later embryonic level.&#xD;
&#xD;
      From a clinical point of view, it would simplify COS (Controlled Ovarian Stimulation) by&#xD;
      reducing the number of medication administered subcutaneously and their possible side effects&#xD;
      on both systemic and local levels. It would be of special interest in 2 groups of patients,&#xD;
      for example, oocyte donors and patients undergoing preservation of fertility. To date, there&#xD;
      is a lack of studies along these lines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 20, 2017</start_date>
  <completion_date type="Actual">June 25, 2019</completion_date>
  <primary_completion_date type="Actual">June 25, 2019</primary_completion_date>
  <phase>Phase 3</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compare number of oocytes using GnRH antagonist versus PMA.</measure>
    <time_frame>36 hours: from triggering until Oocyte retrieval</time_frame>
    <description>Compare oocytes in COS cycles between two groups: using GnRH antagonist versus PMA for avoiding premature luteinization.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">318</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Provera</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Orgalutrán Ganirelix (GnRH antagonist)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Provera 10 mg.</intervention_name>
    <description>One 10 mg tablet of MPA (Medroxyprogesterone acetate) is administered every 24 hours from the onset of Controlled Ovarian Stimulation (COS), until the day of triggering.</description>
    <arm_group_label>Provera</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ganirelix (GnRH antagonist)</intervention_name>
    <description>One ampoule of Ganirelix (GnRH antagonist) a day once diameter of follicles are 14 mm diameter on average until triggering.</description>
    <arm_group_label>Orgalutrán Ganirelix (GnRH antagonist)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18-35 years (both included)&#xD;
&#xD;
          -  Regular Menses (between 25-35 days)&#xD;
&#xD;
          -  Absence of physical and psychic pathologies at the time of oocyte donation&#xD;
&#xD;
          -  BMI: 18-28 kg(m2 at the time of oocyte donation.&#xD;
&#xD;
          -  Other criteria to comply with:&#xD;
&#xD;
             i. With no relevant personal or family medical history ii. Signing of Informed Consent&#xD;
             iii. From a medical point of view:&#xD;
&#xD;
               1. Healthy ovaries and uterus, with no organic pathology&#xD;
&#xD;
               2. Ovaries without polycystic aspect&#xD;
&#xD;
               3. Antral Follicle Count &gt; 12 in the sum of both ovaries&#xD;
&#xD;
               4. Normal Karyotype&#xD;
&#xD;
               5. Negative results in infectious illness screening (Hepatitis B Virus; Hepatitis C&#xD;
                  Virus, VIH Virus Syphilis)&#xD;
&#xD;
               6. Results within range of general analysis of hemogram, hemostasia y biochemistry.&#xD;
&#xD;
                  Exclusion Criteria:&#xD;
&#xD;
          -  Any systemic or metabolic disorder which contraindicate the use of Gonadotrophines&#xD;
&#xD;
          -  Medical background of Trombophlebitis or thromboembolic phenomena or Arterial&#xD;
             Hypertension&#xD;
&#xD;
          -  Severe hepatic insufficiency, cardiovascular illness&#xD;
&#xD;
          -  Suspicion or evidence of malignity of mamarian glands or other hormone dependant&#xD;
             genital organs&#xD;
&#xD;
          -  Known infection of Hepatitis B Virus; Hepatitis C Virus or VIH Virus&#xD;
&#xD;
          -  Known hypersensitivity to PMA or its excipients&#xD;
&#xD;
          -  Any reason or cause which excluede from the oocyte donation program&#xD;
&#xD;
          -  Participation in another clinical trial in the two months prior to the inclusion on&#xD;
             this study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juan Giles, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gynecologist IVI Valencia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IVI Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46015</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <last_update_submitted>August 24, 2021</last_update_submitted>
  <last_update_submitted_qc>August 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2021</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>Medroxyprogesterone Acetate</mesh_term>
    <mesh_term>Ganirelix</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03300960
org study id: 1705-VLC-030-JG
nct id: NCT03300960
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether Medroxyprogesterone Acetate (MPA)
      administration in follicular phase prevents premature luteinization with equal efficiency as
      GnRH antagonists and otains similar clinical results in oocyte donation.
Within the new guidelines for stimulation, the use of oral progesterone in follicular phase
      allows GnRH analogue administration, resulting in greater comfort for patients as well as a
      reduction in cost. Obtained results are similar to those from conventional protocols in terms
      of: early luteinization, number of oocytes, embryos number and rate of implantation and
      gestation or appearance of congenital malformations. Another advantage is the lower incidence
      of OHSS (Ovarian Hyperstimulation Syndrome).

      From a scientific point of view, it would allow a better understanding of folliculogenesis,
      of progesterone mechanism of action on blocking LH secretion and its effect on ovarian and
      later embryonic level.

      From a clinical point of view, it would simplify COS (Controlled Ovarian Stimulation) by
      reducing the number of medication administered subcutaneously and their possible side effects
      on both systemic and local levels. It would be of special interest in 2 groups of patients,
      for example, oocyte donors and patients undergoing preservation of fertility. To date, there
      is a lack of studies along these lines.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Compare number of oocytes using GnRH antagonist versus PMA.
time frame: 36 hours: from triggering until Oocyte retrieval
description: Compare oocytes in COS cycles between two groups: using GnRH antagonist versus PMA for avoiding premature luteinization.
arm group label: Provera
arm group type: Experimental
arm group label: Orgalutrán Ganirelix (GnRH antagonist)
arm group type: Active Comparator
intervention type: Drug
intervention name: Provera 10 mg.
description: One 10 mg tablet of MPA (Medroxyprogesterone acetate) is administered every 24 hours from the onset of Controlled Ovarian Stimulation (COS), until the day of triggering.
arm group label: Provera
intervention type: Drug
intervention name: Ganirelix (GnRH antagonist)
description: One ampoule of Ganirelix (GnRH antagonist) a day once diameter of follicles are 14 mm diameter on average until triggering.
arm group label: Orgalutrán Ganirelix (GnRH antagonist)
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Juan Giles, MD PhD
role: Principal Investigator
affiliation: Gynecologist IVI Valencia
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Infertility
mesh term: Medroxyprogesterone Acetate
mesh term: Ganirelix
sharing ipd: Undecided