Fertility of Spinal Cord Injured Men
Condition: Sperm Parameters of Spinal Cord Injured Men
MeSH terms: Spinal Cord Injuries
Study type: Interventional

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 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.
    

Intervention name(s): penile vibratory stimulation (PVS) or masturbation
Intervention type(s): Other
Intervention description(s): penile vibratory stimulation (PVS) or masturbation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Sperm parameters; Spinal cord injuries; Oxidative stress; Inflammatory syndrome