<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/NCT02992756</url>
  </required_header>
  <id_info>
    <org_study_id>1607-BIO-057-MF</org_study_id>
    <nct_id>NCT02992756</nct_id>
  </id_info>
  <brief_title>Influence of PRGF (Plasma Rich in Growth Factors) Puncture in Ovaries With Low Follicular Reservetechniques</brief_title>
  <acronym>PRGFO-2020</acronym>
  <official_title>Influence of PRGF (Plasma Rich in Growth Factors) Puncture in Ovaries With Low Follicular Reserve</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IVI Bilbao</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IVI Bilbao</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>
      Assisted reproduction patients candidates to an IVF/ICSI cycle with low follicular reserve:&#xD;
      after at least one cycle of stimulation obtaining 0-4 oocytes.&#xD;
&#xD;
      Improve the follicular response in patients with low response, increasing the number of&#xD;
      follicles in subsequent cycles to treatment with growth factors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 29, 2021</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of follicles recruited after instability of ovarian growth factors</measure>
    <time_frame>two months; Time included in two protocols of ovarian stimulation</time_frame>
    <description>o demonstrate an increase of at least 20% in the number of MII oocytes in a cycle after IVF/ICSI treatment with PRGF®-Endoret® compared to previous cycles in low IVF/ICSI patients.&#xD;
IVF/ICSI treatment with PRGF®-Endoret® with respect to previous cycles in low responders.&#xD;
responders</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rates of pregnancy rates</measure>
    <time_frame>three months after embryo transfer after treatment of growth factors</time_frame>
    <description>Increase pregnancy rates and decrease the number of cycles of accumulation of oocytes.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Low Ovarian Reserve</condition>
  <arm_group>
    <arm_group_label>Instillation of growth factors</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients candidates to an IVF/ICSI cycle with low follicular reserve: after at least one cycle of stimulation obtaining 0-3 oocytes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Growth Factors</intervention_name>
    <description>one dose 3-6 mL of PRP obtained by PRGF Endoret</description>
    <arm_group_label>Instillation of growth factors</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients must give written consent.&#xD;
&#xD;
          2. To be a healthy woman acting voluntarily, aged 18 to 42 years (both inclusive) at the&#xD;
             time of study selection time of selection for the study.&#xD;
&#xD;
          3. Have a BMI ≥ 18 kg/m2 and ≤ 35 kg/m2&#xD;
&#xD;
          4. Patients with low ovarian reserve (AMH &lt;1.1 ng/mL) according to the Bologna criteria.&#xD;
&#xD;
          5. Patients who are going to undergo IVF/ICSI cycle with low follicular response: who&#xD;
             after a previous cycle of stimulation have obtained 0-3 or more follicular 0-3 oocytes&#xD;
             have been obtained after a previous stimulation cycle; or if 0-3 oocytes are expected&#xD;
             to be obtained at the present time (less than 4 follicles).&#xD;
&#xD;
             oocytes (less than 4 follicles in the basal ultrasound).&#xD;
&#xD;
          6. To have recent analytical results (haemogram, biochemistry and coagulation); at least&#xD;
             11 months prior to inclusion in the study and a serology, according to clinical&#xD;
             practice.&#xD;
&#xD;
        Translated with www.DeepL.com/Translator (free version)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Marcos Ferrando, PhD</last_name>
    <phone>944806020</phone>
    <email>marcos.ferrando@ivirma.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fernando Quintana</last_name>
    <phone>944806020</phone>
    <email>fernando.quintana@ivirma.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>IVI Bilbao</name>
      <address>
        <city>Leioa</city>
        <state>Vizcaya</state>
        <zip>48940</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marcos Ferrando</last_name>
      <phone>944806020</phone>
      <email>marcos.ferrando@ivirma.com</email>
    </contact>
    <contact_backup>
      <last_name>Fernando Quintana</last_name>
      <phone>944806020</phone>
      <email>fernando.quintana@ivirma.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitogens</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/NCT02992756
org study id: 1607-BIO-057-MF
nct id: NCT02992756
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Assisted reproduction patients candidates to an IVF/ICSI cycle with low follicular reserve:
      after at least one cycle of stimulation obtaining 0-4 oocytes.

      Improve the follicular response in patients with low response, increasing the number of
      follicles in subsequent cycles to treatment with growth factors.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of follicles recruited after instability of ovarian growth factors
time frame: two months; Time included in two protocols of ovarian stimulation
description: o demonstrate an increase of at least 20% in the number of MII oocytes in a cycle after IVF/ICSI treatment with PRGF®-Endoret® compared to previous cycles in low IVF/ICSI patients.
IVF/ICSI treatment with PRGF®-Endoret® with respect to previous cycles in low responders.
responders
measure: Rates of pregnancy rates
time frame: three months after embryo transfer after treatment of growth factors
description: Increase pregnancy rates and decrease the number of cycles of accumulation of oocytes.
arm group label: Instillation of growth factors
arm group type: Experimental
description: Patients candidates to an IVF/ICSI cycle with low follicular reserve: after at least one cycle of stimulation obtaining 0-3 oocytes.
intervention type: Drug
intervention name: Growth Factors
description: one dose 3-6 mL of PRP obtained by PRGF Endoret
arm group label: Instillation of growth factors
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: No
last name: Marcos Ferrando, PhD
phone: 944806020
email: marcos.ferrando@ivirma.com
last name: Fernando Quintana
phone: 944806020
email: fernando.quintana@ivirma.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Spain
responsible party type: Sponsor
mesh term: Mitogens
sharing ipd: No