Semen QualityNCT03760783
The Effects of Microgravity on Human Sperm
A study testing Parabolic flight in people with Semen Quality, run by Fundacion Dexeus at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Semen Quality
- What is being tested?
- Parabolic flight
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 20 Nov 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers (men)
- Who accepted to take part in the study
- Who gave their written informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Women's Health Dexeus Departament d'Obstetrícia, Ginecologia i Reproducció
Barcelona, 08028
About this study
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.
- Conditions
- Semen Quality
- Being tested
- Parabolic flight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parabolic flightOther
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
| Study group | Role | What they receive |
|---|---|---|
| Effect of microgravity on human sperm | Other | Simulated microgravity flight Receives: Other: Parabolic flight |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sperm motility
The percentage of normal spermatozoa in terms of motility grades a,b,c according to WHO
Measured: In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)
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).
Measured: In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)
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).
Measured: In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)
Change in Sperm DNA Fragmentation
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%.
Measured: In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)
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 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.
Measured: In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start20 Nov 2018
- Primary completion1 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Semen QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Politècnica de Catalunya, Dexeus Clinic Woman
- Responsible party
- Principal investigator, Montserrat Boada, Fundacion Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760783
- Sponsor's protocol ID
- FSD-ATM-2018-03
- Status last verified
- Mar 2022
- First submitted
- 15 Nov 2018
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boada M, Perez-Poch A, Ballester M, Garcia-Monclus S, Gonzalez DV, Garcia S, Barri PN, Veiga A. Microgravity effects on frozen human sperm samples. J Assist Reprod Genet. 2020 Sep;37(9):2249-2257. doi: 10.1007/s10815-020-01877-5. Epub 2020 Jul 18.
PubMed 32683528
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Microgravity on Human Sperm
- ClinicalTrials.gov ID
- NCT03760783
- Acronym / sponsor ID
- FSD-ATM-2018-03
- Conditions
- Semen Quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Collaborators
- Universitat Politècnica de Catalunya, Dexeus Clinic Woman
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effect of microgravity on human sperm | Other | Other: Parabolic flightSimulated microgravity flight |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers (men)
- Who accepted to take part in the study
- Who gave their written informed consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parabolic flightSperm 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 | Other | Effect of microgravity on human sperm |
Primary outcome
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
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).
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).
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%.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 32683528Boada M, Perez-Poch A, Ballester M, Garcia-Monclus S, Gonzalez DV, Garcia S, Barri PN, Veiga A. Microgravity effects on frozen human sperm samples. J Assist Reprod Genet. 2020 Sep;37(9):2249-2257. doi: 10.1007/s10815-020-01877-5. Epub 2020 Jul 18.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parabolic flight in people with Semen Quality, run by Fundacion Dexeus at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03760783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.