<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/NCT01689454</url>
  </required_header>
  <id_info>
    <org_study_id>EG48BSept12</org_study_id>
    <secondary_id>EG2</secondary_id>
    <nct_id>NCT01689454</nct_id>
  </id_info>
  <brief_title>ISM1 Versus EmbrioGen Media for Embryo Culture With Previous Failure Implantation in ART Treatments</brief_title>
  <official_title>Prospective Randomized Controlled Trail to Assess the Efficacy of EmbryoGen Culture Medium to Improve Ongoing Pregnancy and Implantation Rates in IVF Treatments of Patients With a Previous History of Implantation Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biogenesi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biogenesi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recently, it has been suggested that culture of embryos in EmbryoGen medium can increase the&#xD;
      live birth rate in IVF patients with a previous history of pregnancy loss.&#xD;
&#xD;
      Couples requiring IVF treatment and with a past experience of implantation failure will be&#xD;
      included in the study.&#xD;
&#xD;
      Controlled ovarian stimulation protocol will consist of an agonist down regulation and&#xD;
      follicular stimulation by recombinant FSH. Fertilization will be achieved by standard IVF or&#xD;
      intracytoplasmic sperm injection. Fertilized eggs will be cultured in 6% CO2, 5% O2, 89% N2&#xD;
      atmosphere in microdrops. In the treatment group EmbryoGen culture medium (EG, Origio, Måløv,&#xD;
      Denmark) will be adopted throughout the culture period. In the control group, inseminated&#xD;
      oocytes will be cultured in standard culture conditions, i.e. IMS1 medium (ISM1, Origio,&#xD;
      Måløv, Denmark), maintaining unchanged all other culture conditions.&#xD;
&#xD;
      Procedures of embryo transfer, will be carried out on day 2 using EmbryoGen or ISM1&#xD;
      respectively. The endometrial support will be the same in the two groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">September 2013</completion_date>
  <primary_completion_date type="Anticipated">June 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ongoing Pregnancy Rate after 12 weeks of gestation</measure>
    <time_frame>12 weeks after conception</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ongoing Implantation Rate after 12 weeks of gestation</measure>
    <time_frame>12 weeks after conception</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Infertility</condition>
  <condition>Implantation Failure</condition>
  <arm_group>
    <arm_group_label>IVF treatment ISM1</arm_group_label>
    <description>Embryo culture in ISM1 medium</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IVF treatment EG</arm_group_label>
    <description>Embryo culture in EmbryoGen medium</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Infertile couple with an indication for standard IVF or intracytoplasmic sperm injection.&#xD;
        Moreover all couples had previous implantation failures after ART treatment (minimun 2&#xD;
        maximun 4 embryo replacements).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women experiencing at least two (maximum 4) failures of implantation after ART&#xD;
             treatments (with elective embryo transfer)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Frozen spermatozoa&#xD;
&#xD;
          -  Frozen oocytes&#xD;
&#xD;
          -  women PCO and PCOS&#xD;
&#xD;
          -  women with previous pregnancy, miscarriage or biochemical pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mariabeatrice Dal Canto, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Biogenesi Reproductive Medicine Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Biogenesi Reproductive Medicine Centre</name>
      <address>
        <city>Monza</city>
        <state>MB</state>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Agerholm I, Loft A, Hald F, Lemmen JG, Munding B, Sorensen PD, Ziebe S. Culture of human oocytes with granulocyte-macrophage colony-stimulating factor has no effect on embryonic chromosomal constitution. Reprod Biomed Online. 2010 Apr;20(4):477-84. doi: 10.1016/j.rbmo.2009.12.026. Epub 2009 Dec 28.</citation>
    <PMID>20129825</PMID>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>September 17, 2012</last_update_submitted>
  <last_update_submitted_qc>September 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>IVF</keyword>
  <keyword>embryo culture</keyword>
  <keyword>Ongoing pregnancy rate</keyword>
  <keyword>Ongoing implantation rate</keyword>
  <keyword>Miscarriage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_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/NCT01689454
org study id: EG48BSept12
secondary id: EG2
nct id: NCT01689454
lead sponsor: 
has dmc: No
Recently, it has been suggested that culture of embryos in EmbryoGen medium can increase the
      live birth rate in IVF patients with a previous history of pregnancy loss.

      Couples requiring IVF treatment and with a past experience of implantation failure will be
      included in the study.

      Controlled ovarian stimulation protocol will consist of an agonist down regulation and
      follicular stimulation by recombinant FSH. Fertilization will be achieved by standard IVF or
      intracytoplasmic sperm injection. Fertilized eggs will be cultured in 6% CO2, 5% O2, 89% N2
      atmosphere in microdrops. In the treatment group EmbryoGen culture medium (EG, Origio, Måløv,
      Denmark) will be adopted throughout the culture period. In the control group, inseminated
      oocytes will be cultured in standard culture conditions, i.e. IMS1 medium (ISM1, Origio,
      Måløv, Denmark), maintaining unchanged all other culture conditions.

      Procedures of embryo transfer, will be carried out on day 2 using EmbryoGen or ISM1
      respectively. The endometrial support will be the same in the two groups.
observational model: Cohort
time perspective: Prospective
measure: Ongoing Pregnancy Rate after 12 weeks of gestation
time frame: 12 weeks after conception
measure: Ongoing Implantation Rate after 12 weeks of gestation
time frame: 12 weeks after conception
arm group label: IVF treatment ISM1
description: Embryo culture in ISM1 medium
arm group label: IVF treatment EG
description: Embryo culture in EmbryoGen medium
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Mariabeatrice Dal Canto, PhD
role: Principal Investigator
affiliation: Biogenesi Reproductive Medicine Centre
facility: 
country: Italy
citation: Agerholm I, Loft A, Hald F, Lemmen JG, Munding B, Sorensen PD, Ziebe S. Culture of human oocytes with granulocyte-macrophage colony-stimulating factor has no effect on embryonic chromosomal constitution. Reprod Biomed Online. 2010 Apr;20(4):477-84. doi: 10.1016/j.rbmo.2009.12.026. Epub 2009 Dec 28.
PMID: 20129825
responsible party type: Sponsor
mesh term: Infertility