<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/NCT03809026</url>
  </required_header>
  <id_info>
    <org_study_id>Lab.Reprod.Biol. - Odense.03</org_study_id>
    <nct_id>NCT03809026</nct_id>
  </id_info>
  <brief_title>The Potential of Sperm Retrieved by Micro-TESE to Fertilize Vitrified/Warmed Oocytes</brief_title>
  <official_title>The Potential of Sperm Retrieved by Micro-TESE to Fertilize Vitrified/Warmed Oocytes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      Couples referred for microdissection-TESE (m-TESE) due to Klinefelter's syndrome, maturation&#xD;
      stop in the spermatogenesis, or failed retrieval of testicular spermatozoa by conventional&#xD;
      techniques with needle or TruCut are included. The women are stimulated with FSH in IVF&#xD;
      protocols and the aspirated oocytes vitrified with usual applied techniques. Fresh sperm&#xD;
      retrieved by micro-TESE are used for fertilization of the warmed oocytes. when it is not&#xD;
      possible to obtain testicular sperm, the couples are offered fertilization with warmed&#xD;
      oocytes.&#xD;
&#xD;
      Fertilization, cleavage, implantation and pregnancy rates using sperm from the patients&#xD;
      versus from sperm donors will be compared.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2015</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cleavage rate</measure>
    <time_frame>six years</time_frame>
    <description>Measurement of % of cleavage among the warmed oocytes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pregnancy rate</measure>
    <time_frame>six years</time_frame>
    <description>Measurement of serum-hCG and ultrasonography at gestation age week 7</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fertilization rate</measure>
    <time_frame>six years</time_frame>
    <description>Measurement of % of fertilization among the warmed oocytes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implantation rate</measure>
    <time_frame>six years</time_frame>
    <description>Measurement of the % of transferred embryos implanting into the uterus</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Azoospermia, Nonobstructive</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <description>Couples where the men have Klinefelter's syndrome, maturation stop in the spermatogenesis or failed retrieval of testicular sperm by conventional techniques with needle or TruCut, and where testicular sperm could be obtained by micro-TESE.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Couples as in the study group, but where testicular sperm could not be obtained by micro-TESE. The oocytes therefore must be fertilized using donor sperm.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Men referred to micro-TESE due to Klinefelter's syndrome, maturation stop in the&#xD;
        spermatogenesis, or failed sperm retrieval using conventional needles or TruCut.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Couples referred for micro-TESE&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Actually we treat infertile couples with a man and a woman, but the variable originates from the man.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Jens Fedder, MD, PhD</last_name>
    <phone>+45 26820368</phone>
    <email>fedder@dadlnet.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Centre of Andrology &amp; Fertility Clinic, Department D, Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <zip>DK-5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jens Fedder, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre of Andrology &amp; Fertility Clinic, Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <zip>DK-5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jens Fedder, MD, PhD</last_name>
      <phone>+45 26820368</phone>
      <email>fedder@dadlnet.dk</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>May 25, 2022</last_update_submitted>
  <last_update_submitted_qc>May 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Jens Fedder</investigator_full_name>
    <investigator_title>Professor, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Azoospermia</keyword>
  <keyword>micro-TESE</keyword>
  <keyword>Klinefelter's syndrome</keyword>
  <keyword>Cryptorchidism</keyword>
  <keyword>Vitrified oocytes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azoospermia</mesh_term>
  </condition_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/NCT03809026
org study id: Lab.Reprod.Biol. - Odense.03
nct id: NCT03809026
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Couples referred for microdissection-TESE (m-TESE) due to Klinefelter's syndrome, maturation
      stop in the spermatogenesis, or failed retrieval of testicular spermatozoa by conventional
      techniques with needle or TruCut are included. The women are stimulated with FSH in IVF
      protocols and the aspirated oocytes vitrified with usual applied techniques. Fresh sperm
      retrieved by micro-TESE are used for fertilization of the warmed oocytes. when it is not
      possible to obtain testicular sperm, the couples are offered fertilization with warmed
      oocytes.

      Fertilization, cleavage, implantation and pregnancy rates using sperm from the patients
      versus from sperm donors will be compared.
observational model: Case-Control
time perspective: Prospective
measure: Cleavage rate
time frame: six years
description: Measurement of % of cleavage among the warmed oocytes
measure: Pregnancy rate
time frame: six years
description: Measurement of serum-hCG and ultrasonography at gestation age week 7
measure: Fertilization rate
time frame: six years
description: Measurement of % of fertilization among the warmed oocytes
measure: Implantation rate
time frame: six years
description: Measurement of the % of transferred embryos implanting into the uterus
arm group label: Study group
description: Couples where the men have Klinefelter's syndrome, maturation stop in the spermatogenesis or failed retrieval of testicular sperm by conventional techniques with needle or TruCut, and where testicular sperm could be obtained by micro-TESE.
arm group label: Control group
description: Couples as in the study group, but where testicular sperm could not be obtained by micro-TESE. The oocytes therefore must be fertilized using donor sperm.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
gender based: Yes
gender description: Actually we treat infertile couples with a man and a woman, but the variable originates from the man.
minimum age: 18 Years
maximum age: 100 Years
last name: Jens Fedder, MD, PhD
phone: +45 26820368
email: fedder@dadlnet.dk
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Jens Fedder
investigator title: Professor, MD, PhD
mesh term: Azoospermia
sharing ipd: Undecided