<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/NCT03760783</url>
  </required_header>
  <id_info>
    <org_study_id>FSD-ATM-2018-03</org_study_id>
    <nct_id>NCT03760783</nct_id>
  </id_info>
  <brief_title>The Effects of Microgravity on Human Sperm</brief_title>
  <official_title>The Effects of Microgravity on Human Sperm</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Universitari Dexeus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universitat Politècnica de Catalunya</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dexeus Clinic Woman</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut Universitari Dexeus</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>
      It has been described that microgravity affects cellular and molecular structures. Cell&#xD;
      membrane, cytoskeleton, cytoplasm and nucleus have been found to be sensible to gravitational&#xD;
      changes. Alterations in the male and female reproductive systems have also been reported in&#xD;
      mouse and other animals. The effects of microgravity on human reproductive cells remain&#xD;
      unknown.&#xD;
&#xD;
      The main objective of this experimental study is to investigate the effect of simulated&#xD;
      microgravity in human male reproductive cells under in vitro conditions. Induced microgravity&#xD;
      conditions will be obtained with a smaller single-engine aerobatic aircraft that can provide&#xD;
      parabolic flights.&#xD;
&#xD;
      The main parameters to be analyzed are: sperm motility, vitality, DNA fragmentation and&#xD;
      apoptosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2018</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 1, 2021</primary_completion_date>
  <phase>N/A</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Sperm motility</measure>
    <time_frame>In earth gravity g=1(&lt;4 hours before Parabolic flight) and after simulated microgravity exposure (&lt;4 hours Post Parabolic Flight)</time_frame>
    <description>The percentage of normal spermatozoa in terms of motility grades a,b,c according to WHO</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change Sperm Morphology</measure>
    <time_frame>In earth gravity g=1(&lt;4 hours before Parabolic flight) and after simulated microgravity exposure (&lt;4 hours Post Parabolic Flight)</time_frame>
    <description>The percentage of normal spermatozoa in terms of morphology is assessed by staining. The lower reference limit for normal forms is 4% (WHO 2010).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change Sperm Vitality</measure>
    <time_frame>In earth gravity g=1(&lt;4 hours before Parabolic flight) and after simulated microgravity exposure (&lt;4 hours Post Parabolic Flight)</time_frame>
    <description>The percentage of live spermatozoa is assessed by identifying those with an intact cell membrane, from dye exclusion. The lower reference limit for vitality (membrane-intact spermatozoa) is 58% (WHO 2010).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Sperm DNA Fragmentation</measure>
    <time_frame>In earth gravity g=1(&lt;4 hours before Parabolic flight) and after simulated microgravity exposure (&lt;4 hours Post Parabolic Flight)</time_frame>
    <description>Sperm DNA fragmentation is evaluated by Halosperm® kit, based on the SCD technique, patented by Halotech. This kit is based on a controlled DNA denaturation process to facilitate the subsequent removal of the proteins contained in each spermatozoon. In this way, normal spermatozoa create halos formed by loops of DNA at the head of the sperm, which are not present in those with damaged DNA.&#xD;
Thresholds for frequency of Sperm DNA Fragmentation (SDF) have been suggested by Dr. Evenson et al. (Evenson and Nixon, Reprod Biomed Online 12:466-472, 2006). The authors reported that couples with no known infertility problems were more likely to achieve a pregnancy/delivery if the DNA fragmentation index (DFI) was &lt;30%.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change Sperm APOPTOSIS (Annexin V )</measure>
    <time_frame>In earth gravity g=1(&lt;4 hours before Parabolic flight) and after simulated microgravity exposure (&lt;4 hours Post Parabolic Flight)</time_frame>
    <description>Annexin V recognizes an antigen (externalized phosphatidylserine, EPS) in the plasma membrane of apoptotic cells. Apoptotic cell depletion begins with the magnetic labeling of apoptotic cells by the MACS® ART Annexin V Reagent. The labeled cells are then passed through a separation column located in a fixed magnetic field. Unwanted cells are selectively retained in the column. Living spermatozoa are not labeled by the reagent, so they pass through the column and are collected for later use.&#xD;
In our study, after collecting living spermatozoa we also collected the retained apoptotic spermatozoa for comparing the concentration (M/ml) of apoptotic vs no apoptotic cells.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Semen Quality</condition>
  <arm_group>
    <arm_group_label>Effect of microgravity on human sperm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Simulated microgravity flight</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Parabolic flight</intervention_name>
    <description>Sperm analysis (total motility M/ml; grade a+b sperm M/ml, vitality, DNA Frag and apoptosis) will be measured on ground at 1g before the flight and after flight were sperm samples have been exposed to simulated microgravity</description>
    <arm_group_label>Effect of microgravity on human sperm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers (men)&#xD;
&#xD;
          -  Who accepted to take part in the study&#xD;
&#xD;
          -  Who gave their written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Women's Health Dexeus Departament d'Obstetrícia, Ginecologia i Reproducció</name>
      <address>
        <city>Barcelona</city>
        <zip>08028</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>https://www.dexeus.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>March 30, 2022</last_update_submitted>
  <last_update_submitted_qc>March 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institut Universitari Dexeus</investigator_affiliation>
    <investigator_full_name>Montserrat Boada</investigator_full_name>
    <investigator_title>Director of Reproductive Laboratory</investigator_title>
  </responsible_party>
  <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/NCT03760783
org study id: FSD-ATM-2018-03
nct id: NCT03760783
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It has been described that microgravity affects cellular and molecular structures. Cell
      membrane, cytoskeleton, cytoplasm and nucleus have been found to be sensible to gravitational
      changes. Alterations in the male and female reproductive systems have also been reported in
      mouse and other animals. The effects of microgravity on human reproductive cells remain
      unknown.

      The main objective of this experimental study is to investigate the effect of simulated
      microgravity in human male reproductive cells under in vitro conditions. Induced microgravity
      conditions will be obtained with a smaller single-engine aerobatic aircraft that can provide
      parabolic flights.

      The main parameters to be analyzed are: sperm motility, vitality, DNA fragmentation and
      apoptosis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in Sperm motility
time frame: In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)
description: The percentage of normal spermatozoa in terms of motility grades a,b,c according to WHO
measure: Change Sperm Morphology
time frame: In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)
description: The percentage of normal spermatozoa in terms of morphology is assessed by staining. The lower reference limit for normal forms is 4% (WHO 2010).
measure: Change Sperm Vitality
time frame: In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)
description: The percentage of live spermatozoa is assessed by identifying those with an intact cell membrane, from dye exclusion. The lower reference limit for vitality (membrane-intact spermatozoa) is 58% (WHO 2010).
measure: Change in Sperm DNA Fragmentation
time frame: In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)
description: Sperm DNA fragmentation is evaluated by Halosperm® kit, based on the SCD technique, patented by Halotech. This kit is based on a controlled DNA denaturation process to facilitate the subsequent removal of the proteins contained in each spermatozoon. In this way, normal spermatozoa create halos formed by loops of DNA at the head of the sperm, which are not present in those with damaged DNA.
Thresholds for frequency of Sperm DNA Fragmentation (SDF) have been suggested by Dr. Evenson et al. (Evenson and Nixon, Reprod Biomed Online 12:466-472, 2006). The authors reported that couples with no known infertility problems were more likely to achieve a pregnancy/delivery if the DNA fragmentation index (DFI) was <30%.
measure: Change Sperm APOPTOSIS (Annexin V )
time frame: In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)
description: Annexin V recognizes an antigen (externalized phosphatidylserine, EPS) in the plasma membrane of apoptotic cells. Apoptotic cell depletion begins with the magnetic labeling of apoptotic cells by the MACS® ART Annexin V Reagent. The labeled cells are then passed through a separation column located in a fixed magnetic field. Unwanted cells are selectively retained in the column. Living spermatozoa are not labeled by the reagent, so they pass through the column and are collected for later use.
In our study, after collecting living spermatozoa we also collected the retained apoptotic spermatozoa for comparing the concentration (M/ml) of apoptotic vs no apoptotic cells.
arm group label: Effect of microgravity on human sperm
arm group type: Other
description: Simulated microgravity flight
intervention type: Other
intervention name: Parabolic flight
description: Sperm analysis (total motility M/ml; grade a+b sperm M/ml, vitality, DNA Frag and apoptosis) will be measured on ground at 1g before the flight and after flight were sperm samples have been exposed to simulated microgravity
arm group label: Effect of microgravity on human sperm
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Spain
url: https://www.dexeus.com/
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Institut Universitari Dexeus
investigator full name: Montserrat Boada
investigator title: Director of Reproductive Laboratory
sharing ipd: No