Sperm Parameters of Spinal Cord Injured MenFertiSCINCT02144558
Fertility of Spinal Cord Injured Men
A study testing penile vibratory stimulation (PVS) or masturbation in people with Sperm Parameters of Spinal Cord Injured Men, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Spinal cord injured (SCI) men, para or tetraplegic, most often have an infertility, caused among others by a deficiency of sperm quality particularly motility and vitality. Several mechanisms have been proposed: low frequency of ejaculation, recurrent urinary tract and seminal infections, presence of an inflammatory… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Sperm Parameters of Spinal Cord Injured Men
- What is being tested?
- penile vibratory stimulation (PVS) or masturbation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 24 Apr 2014to 5 Apr 2018
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Spinal cord injured men aged between 18 and 60 years
- Strict antegrade ejaculation obtained by masturbation or penil vibratory stimulation
- Signature of an informed and written consent to participate to the study.
Who cannot join
- Total or partial retrograde ejaculation
- Major patients protected
- Men no affiliated with a french social security regime.
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique-Hôpitaux de Paris, Cochin Hospital, Department of Biology of Reproduction
Paris, 75014
About this study
Official title: Evolution of Sperm Parameters and Study of Risk Factors of Impairment of Sperm Quality in Spinal Cord Injuries. Longitudinal Prospective Study.
Spinal cord injured (SCI) men, para or tetraplegic, most often have an infertility, caused among others by a deficiency of sperm quality particularly motility and vitality. Several mechanisms have been proposed: low frequency of ejaculation, recurrent urinary tract and seminal infections, presence of an inflammatory syndrome (IS) and an oxidative stress (OS). However, no French study of sperm quality has been conducted in this population that could identify aggravating factors of sperm quality and a way to prevent them.
Hypothesis: Sperm parameters decrease rapidly following spinal cord injury and next stabilise. However, unidentified yet risk factors could influence long-term evolution of sperm parameters.
The objective is to study the evolution of sperm parameters during 18 months taking into account bladder management, recurrent urinary tract and bladder infections, IS and OS. The evaluation of these parameters and their consequences will be indicative to determine one or more risk factors of sperm degradation and determine a strategy for long term support to avoid the use of ART either by sperm cryopreservation and/or by preventing risk factors
Read the detailed description
SCI men are mostly young adults who have not completed their parental project. Infertility has many causes: erectile dysfunction, anejaculation (85% of SCI ) and altered sperm parameters. Penile vibratory stimulation allows 75 % of the sperm collection. If sperm quality is sufficient, intravaginal insemination of their partner at home is possible. The use of AMP remains common, which is damaging to men non sterile priori. In SCI, sperm concentration remains satisfactory but mobility and vitality are impaired. The installation of this irreversible degradation likely occurs very quickly after the trauma. The possible deterioration of sperm parameters with time is not known. The following pathophysiological mechanisms have been proposed: i) increased scrotal temperature, ii) decreased ejaculatory frequency, iii) recurrent urinary tract and seminal infections, iv ) inflammation and oxidative stress in the semen. Patients, and even rehabilitation doctors often submit an application for preventive sperm conservation but in the absence of prospective longitudinal data on the evolution of sperm quality of SCI men over the time and identified risk factors of degradation, the indication and timing of preventive cryopreservation remain to be defined.
Hypothesis: The sperm parameters, mobility and vitality, in SCI patients with or without penile vibratory stimulation (PVS), decrease in the immediate aftermath of trauma and next stabilize out the occurrence of intercurrent medical events or symptomatic urogenital infections. However, unidentified yet risk factors could influence long-term evolution of these sperm parameters.
Main objective: Monitoring the evolution of sperm parameters for 18 months: concentration, mobility, vitality, sperm morphology, inflammatory syndrome and oxidative stress on 4 ejaculates collected by masturbation or SVP at 6-month intervals.
Secondary objectives: In case of impaired sperm quality, identify risk factors for this change.
SCI men will have 4 medical visits associated to sperm retrieval spaced to 6 months during 18 months. At each visit medical and reproductive informations will be collected.
Knowledge of the evolution of sperm parameters and risk factors of its degradation over time must answer with the criteria of "evidence based medicine" the request of sperm cryopreservation frequently expressed by SCI patients. This study should lead to the optimization of the management of infertility in patients with spinal cord injuries and giving directions for research aiming to prevent the degradation of sperm parameters. Finally, this study should provide the rationale for future research on clinical risk factors and / or biological degradation of sperm and biological markers of risk of degradation.
- Being tested
- penile vibratory stimulation (PVS) or masturbation
- Keywords
- Sperm parameters, Spinal cord injuries, Oxidative stress, Inflammatory syndrome
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
penile vibratory stimulation (PVS) or masturbationOther
penile vibratory stimulation (PVS) or masturbation
| Study group | Role | What they receive |
|---|---|---|
| Spinal cord injured (SCI) men, para or tetraplegic | Experimental | SCI men will have 4 medical visits associated to sperm retrieval (penile vibratory stimulation (PVS) or masturbation) Receives: Other: penile vibratory stimulation (PVS) or masturbation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm viability: percent of live spermatozoa among 100 counted spermatozoa.
Sperm viability is a stable criteria of evaluation and it has a good repeatability in our lab.
Sperm viability is measured on fresh sperm 30 minutes after ejaculation using eosine nigrosine coloration. This measure is repeated on each of the four ejaculates obtained at 6 months apart.
Measured: 18 month
Secondary outcomes (39)
spermogram
Sperm concentration, mobility and morphology
Measured: 18 months
elastase
Measure of inflammation
Measured: 6 month
DNA fragmentation
Sperm DNA integrity, measures oxidative stress
Measured: 18 months
8 Hydroxydesoxyguanosine (8OHdG)
Oxydative stress
Measured: 18 months
Seminal biochemistry
Secretion of seminal tract
Measured: 18 months
Urinary and seminal infections
Bacteriological analysis of sperm and urine
Measured: 18 months
Mode of urinary catheter
Measured: 18 months
Spinal cord injury type
Type and level of the lesion
Measured: 0 months
Concomitant treatments
Measured: 18 months
Patient age and time to spinal cord injury
Measured: 18 months
Sperm viability: percent of live spermatozoa among 100 counted spermatozoa.
Sperm viability is a stable criteria of evaluation and it has a good repeatability in our lab.
Sperm viability is measured on fresh sperm 30 minutes after ejaculation using eosine nigrosine coloration. This measure is repeated on each of the four ejaculates obtained at 6 months apart.
Measured: 6 months
Sperm viability: percent of live spermatozoa among 100 counted spermatozoa.
Sperm viability is a stable criteria of evaluation and it has a good repeatability in our lab.
Sperm viability is measured on fresh sperm 30 minutes after ejaculation using eosine nigrosine coloration. This measure is repeated on each of the four ejaculates obtained at 6 months apart.
Measured: 12 months
Sperm viability: percent of live spermatozoa among 100 counted spermatozoa.
Sperm viability is a stable criteria of evaluation and it has a good repeatability in our lab.
Sperm viability is measured on fresh sperm 30 minutes after ejaculation using eosine nigrosine coloration. This measure is repeated on each of the four ejaculates obtained at 6 months apart.
Measured: 0 months
elastase
Measure of inflammation
Measured: 0 month
elastase
Measure of inflammation
Measured: 12 month
elastase
Measure of inflammation
Measured: 18 month
spermogram
Sperm concentration, mobility and morphology
Measured: 0 months
spermogram
Sperm concentration, mobility and morphology
Measured: 6 months
spermogram
Sperm concentration, mobility and morphology
Measured: 12 months
DNA fragmentation
Sperm DNA integrity, measures oxidative stress
Measured: 0 month
DNA fragmentation
Sperm DNA integrity, measures oxidative stress
Measured: 6 months
DNA fragmentation
Sperm DNA integrity, measures oxidative stress
Measured: 12 months
8 Hydroxydesoxyguanosine (8OHdG)
Oxydative stress
Measured: 0 months
8 Hydroxydesoxyguanosine (8OHdG)
Oxydative stress
Measured: 6 months
Seminal biochemistry
Secretion of seminal tract
Measured: 0 months
Seminal biochemistry
Secretion of seminal tract
Measured: 6 months
Seminal biochemistry
Secretion of seminal tract
Measured: 12 months
Urinary and seminal infections
Bacteriological analysis of sperm and urine
Measured: 0 months
Urinary and seminal infections
Bacteriological analysis of sperm and urine
Measured: 6 months
Urinary and seminal infections
Bacteriological analysis of sperm and urine
Measured: 12 months
Mode of urinary catheter
Measured: 0 months
Mode of urinary catheter
Measured: 6 months
Mode of urinary catheter
Measured: 12 months
Concomitant treatments
Measured: 0 month
Concomitant treatments
Measured: 6 months
Concomitant treatments
Measured: 12 months
Patient age and time to spinal cord injury
Measured: 0 month
Patient age and time to spinal cord injury
Measured: 6 months
Patient age and time to spinal cord injury
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study start24 Apr 2014
- Primary completion5 Apr 2018
- Study completion5 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sperm Parameters of Spinal Cord Injured MenStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Agence de La Biomédecine, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Céline Chalas, PhD, Principal investigator, Cochin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144558
- Sponsor's protocol ID
- P130703
- Acronym
- FertiSCI
- Status last verified
- Sep 2025
- First submitted
- 19 May 2014
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Iremashvili V, Brackett NL, Ibrahim E, Aballa TC, Lynne CM. Semen quality remains stable during the chronic phase of spinal cord injury: a longitudinal study. J Urol. 2010 Nov;184(5):2073-7. doi: 10.1016/j.juro.2010.06.112. Epub 2010 Sep 17.
PubMed 20850834Padron OF, Brackett NL, Sharma RK, Lynne CM, Thomas AJ Jr, Agarwal A. Seminal reactive oxygen species and sperm motility and morphology in men with spinal cord injury. Fertil Steril. 1997 Jun;67(6):1115-20. doi: 10.1016/s0015-0282(97)81448-3.
PubMed 9176453Brackett NL, Ibrahim E, Grotas JA, Aballa TC, Lynne CM. Higher sperm DNA damage in semen from men with spinal cord injuries compared with controls. J Androl. 2008 Jan-Feb;29(1):93-9; discussion 100-1. doi: 10.2164/jandrol.107.003574. Epub 2007 Sep 5.
PubMed 17804864Chalas C, Jilet L, Wolf JP, Drouineaud V, Abdoul H, Patrat C, Denys P, Giuliano F. Prospective analysis over time of semen parameters in spinal cord-injured patients: Results of a pilot study. Andrology. 2022 Jan;10(1):120-127. doi: 10.1111/andr.13089. Epub 2021 Aug 13.
PubMed 34347944
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Sperm Parameters and Study of Risk Factors of Impairment of Sperm Quality in Spinal Cord Injuries. Longitudinal Prospective Study.
- ClinicalTrials.gov ID
- NCT02144558
- Acronym / sponsor ID
- FertiSCI / P130703
- Keywords
- Sperm parameters, Spinal cord injuries, Oxidative stress, Inflammatory syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Agence de La Biomédecine, URC-CIC Paris Descartes Necker Cochin
- Study start
- 24 Apr 2014 (actual)
- Primary completion
- 5 Apr 2018 (actual)
- Study completion
- 5 Apr 2018 (actual)
- First posted
- 22 May 2014 (estimated)
- 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.
Spinal cord injured (SCI) men, para or tetraplegic, most often have an infertility, caused among others by a deficiency of sperm quality particularly motility and vitality. Several mechanisms have been proposed: low frequency of ejaculation, recurrent urinary tract and seminal infections, presence of an inflammatory syndrome (IS) and an oxidative stress (OS). However, no French study of sperm quality has been conducted in this population that could identify aggravating factors of sperm quality and a way to prevent them.
Hypothesis: Sperm parameters decrease rapidly following spinal cord injury and next stabilise. However, unidentified yet risk factors could influence long-term evolution of sperm parameters.
The objective is to study the evolution of sperm parameters during 18 months taking into account bladder management, recurrent urinary tract and bladder infections, IS and OS. The evaluation of these parameters and their consequences will be indicative to determine one or more risk factors of sperm degradation and determine a strategy for long term support to avoid the use of ART either by sperm cryopreservation and/or by preventing risk factors
Detailed description
SCI men are mostly young adults who have not completed their parental project. Infertility has many causes: erectile dysfunction, anejaculation (85% of SCI ) and altered sperm parameters. Penile vibratory stimulation allows 75 % of the sperm collection. If sperm quality is sufficient, intravaginal insemination of their partner at home is possible. The use of AMP remains common, which is damaging to men non sterile priori. In SCI, sperm concentration remains satisfactory but mobility and vitality are impaired. The installation of this irreversible degradation likely occurs very quickly after the trauma. The possible deterioration of sperm parameters with time is not known. The following pathophysiological mechanisms have been proposed: i) increased scrotal temperature, ii) decreased ejaculatory frequency, iii) recurrent urinary tract and seminal infections, iv ) inflammation and oxidative stress in the semen. Patients, and even rehabilitation doctors often submit an application for preventive sperm conservation but in the absence of prospective longitudinal data on the evolution of sperm quality of SCI men over the time and identified risk factors of degradation, the indication and timing of preventive cryopreservation remain to be defined.
Hypothesis: The sperm parameters, mobility and vitality, in SCI patients with or without penile vibratory stimulation (PVS), decrease in the immediate aftermath of trauma and next stabilize out the occurrence of intercurrent medical events or symptomatic urogenital infections. However, unidentified yet risk factors could influence long-term evolution of these sperm parameters.
Main objective: Monitoring the evolution of sperm parameters for 18 months: concentration, mobility, vitality, sperm morphology, inflammatory syndrome and oxidative stress on 4 ejaculates collected by masturbation or SVP at 6-month intervals.
Secondary objectives: In case of impaired sperm quality, identify risk factors for this change.
SCI men will have 4 medical visits associated to sperm retrieval spaced to 6 months during 18 months. At each visit medical and reproductive informations will be collected.
Knowledge of the evolution of sperm parameters and risk factors of its degradation over time must answer with the criteria of "evidence based medicine" the request of sperm cryopreservation frequently expressed by SCI patients. This study should lead to the optimization of the management of infertility in patients with spinal cord injuries and giving directions for research aiming to prevent the degradation of sperm parameters. Finally, this study should provide the rationale for future research on clinical risk factors and / or biological degradation of sperm and biological markers of risk of degradation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal cord injured (SCI) men, para or tetraplegic | Experimental | Other: penile vibratory stimulation (PVS) or masturbationSCI men will have 4 medical visits associated to sperm retrieval (penile vibratory stimulation (PVS) or masturbation) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Spinal cord injured men aged between 18 and 60 years
- Strict antegrade ejaculation obtained by masturbation or penil vibratory stimulation
- Signature of an informed and written consent to participate to the study.
Key exclusion criteria (3 listed)
- Total or partial retrograde ejaculation
- Major patients protected
- Men no affiliated with a french social security regime.
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 |
|---|---|---|
| penile vibratory stimulation (PVS) or masturbationpenile vibratory stimulation (PVS) or masturbation | Other | Spinal cord injured (SCI) men, para or tetraplegic |
Primary outcome
Sperm viability: percent of live spermatozoa among 100 counted spermatozoa.
Time frame: 18 month
Sperm viability is a stable criteria of evaluation and it has a good repeatability in our lab. Sperm viability is measured on fresh sperm 30 minutes after ejaculation using eosine nigrosine coloration. This measure is repeated on each of the four ejaculates obtained at 6 months apart.
39 secondary outcomes
spermogram
Time frame: 18 months
elastase
Time frame: 6 month
DNA fragmentation
Time frame: 18 months
8 Hydroxydesoxyguanosine (8OHdG)
Time frame: 18 months
Seminal biochemistry
Time frame: 18 months
Urinary and seminal infections
Time frame: 18 months
Mode of urinary catheter
Time frame: 18 months
Spinal cord injury type
Time frame: 0 months
Concomitant treatments
Time frame: 18 months
Patient age and time to spinal cord injury
Time frame: 18 months
Sperm viability: percent of live spermatozoa among 100 counted spermatozoa.
Time frame: 6 months
Sperm viability: percent of live spermatozoa among 100 counted spermatozoa.
Time frame: 12 months
Sperm viability: percent of live spermatozoa among 100 counted spermatozoa.
Time frame: 0 months
elastase
Time frame: 0 month
elastase
Time frame: 12 month
elastase
Time frame: 18 month
spermogram
Time frame: 0 months
spermogram
Time frame: 6 months
spermogram
Time frame: 12 months
DNA fragmentation
Time frame: 0 month
DNA fragmentation
Time frame: 6 months
DNA fragmentation
Time frame: 12 months
8 Hydroxydesoxyguanosine (8OHdG)
Time frame: 0 months
8 Hydroxydesoxyguanosine (8OHdG)
Time frame: 6 months
Seminal biochemistry
Time frame: 0 months
Seminal biochemistry
Time frame: 6 months
Seminal biochemistry
Time frame: 12 months
Urinary and seminal infections
Time frame: 0 months
Urinary and seminal infections
Time frame: 6 months
Urinary and seminal infections
Time frame: 12 months
Mode of urinary catheter
Time frame: 0 months
Mode of urinary catheter
Time frame: 6 months
Mode of urinary catheter
Time frame: 12 months
Concomitant treatments
Time frame: 0 month
Concomitant treatments
Time frame: 6 months
Concomitant treatments
Time frame: 12 months
Patient age and time to spinal cord injury
Time frame: 0 month
Patient age and time to spinal cord injury
Time frame: 6 months
Patient age and time to spinal cord injury
Time frame: 12 months
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 11 Sep 2025.
- Background: PubMed 20850834Iremashvili V, Brackett NL, Ibrahim E, Aballa TC, Lynne CM. Semen quality remains stable during the chronic phase of spinal cord injury: a longitudinal study. J Urol. 2010 Nov;184(5):2073-7. doi: 10.1016/j.juro.2010.06.112. Epub 2010 Sep 17.
- Background: PubMed 9176453Padron OF, Brackett NL, Sharma RK, Lynne CM, Thomas AJ Jr, Agarwal A. Seminal reactive oxygen species and sperm motility and morphology in men with spinal cord injury. Fertil Steril. 1997 Jun;67(6):1115-20. doi: 10.1016/s0015-0282(97)81448-3.
- Background: PubMed 17804864Brackett NL, Ibrahim E, Grotas JA, Aballa TC, Lynne CM. Higher sperm DNA damage in semen from men with spinal cord injuries compared with controls. J Androl. 2008 Jan-Feb;29(1):93-9; discussion 100-1. doi: 10.2164/jandrol.107.003574. Epub 2007 Sep 5.
- Results publication: PubMed 34347944Chalas C, Jilet L, Wolf JP, Drouineaud V, Abdoul H, Patrat C, Denys P, Giuliano F. Prospective analysis over time of semen parameters in spinal cord-injured patients: Results of a pilot study. Andrology. 2022 Jan;10(1):120-127. doi: 10.1111/andr.13089. Epub 2021 Aug 13.
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.
Céline Chalas, PhD principal investigator
Cochin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing penile vibratory stimulation (PVS) or masturbation in people with Sperm Parameters of Spinal Cord Injured Men, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 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 11 Sep 2025. 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 France. 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?
Sperm viability: percent of live spermatozoa among 100 counted spermatozoa. (time frame: 18 month). 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 NCT02144558, which also lists 4 linked publications.
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 11 Sep 2025.