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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03760783
Other study ID # FSD-ATM-2018-03
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 20, 2018
Est. completion date December 31, 2021

Study information

Verified date March 2022
Source Institut Universitari Dexeus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 31, 2021
Est. primary completion date December 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Healthy volunteers (men) - Who accepted to take part in the study - Who gave their written informed consent

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain Women's Health Dexeus Departament d'Obstetrícia, Ginecologia i Reproducció Barcelona

Sponsors (3)

Lead Sponsor Collaborator
Institut Universitari Dexeus Dexeus Clinic Woman, Universitat Politècnica de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Sperm motility The percentage of normal spermatozoa in terms of motility grades a,b,c according to WHO In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)
Primary Change Sperm Morphology The percentage of normal spermatozoa in terms of morphology is assessed by staining. The lower reference limit for normal forms is 4% (WHO 2010). In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)
Primary Change Sperm Vitality 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). In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)
Primary Change in Sperm DNA Fragmentation Sperm DNA fragmentation is evaluated by HalospermĀ® 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%.
In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)
Primary Change Sperm APOPTOSIS (Annexin V ) 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 MACSĀ® 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.
In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)
See also
  Status Clinical Trial Phase
Recruiting NCT03464656 - Oxidative Stress In Semen And Male Infertility Phase 4
Terminated NCT01296230 - Varicocelectomy: Can Sex-hormones Predict Improvements in Semen Quality? N/A
Completed NCT02667080 - Sperm Quality in Consecutive Sperm Samples After 4-7 Days and 2 Hours of Sexual Abstinence N/A

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