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The Effects of Microgravity on Human Sperm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03760783
Recruitment Status : Completed
First Posted : November 30, 2018
Last Update Posted : March 31, 2022
Sponsor:
Collaborators:
Universitat Politècnica de Catalunya
Dexeus Clinic Woman
Information provided by (Responsible Party):
Montserrat Boada, Institut Universitari Dexeus

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Semen Quality Other: Parabolic flight Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effects of Microgravity on Human Sperm
Actual Study Start Date : November 20, 2018
Actual Primary Completion Date : December 1, 2021
Actual Study Completion Date : December 31, 2021
Arms and Interventions
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Arm Intervention/treatment
Effect of microgravity on human sperm
Simulated microgravity flight
 Other: Parabolic flight
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


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    The percentage of normal spermatozoa in terms of motility grades a,b,c according to WHO

  2. 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) ]
    The percentage of normal spermatozoa in terms of morphology is assessed by staining. The lower reference limit for normal forms is 4% (WHO 2010).

  3. 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) ]
    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).

  4. 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) ]

    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%.


  5. 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) ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers (men)
  • Who accepted to take part in the study
  • Who gave their written informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760783


Locations
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Spain
Women's Health Dexeus Departament d'Obstetrícia, Ginecologia i Reproducció
Barcelona, Spain, 08028
Sponsors and Collaborators
Institut Universitari Dexeus
Universitat Politècnica de Catalunya
Dexeus Clinic Woman
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Montserrat Boada, Director of Reproductive Laboratory, Institut Universitari Dexeus
ClinicalTrials.gov Identifier: NCT03760783    
Other Study ID Numbers: FSD-ATM-2018-03
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No