Evolution of Sperm Parameters and Study of Risk Factors of Impairment of Sperm Quality in Spinal Cord Injuries. Longitudinal Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Sperm viability: percent of live spermatozoa among 100 counted spermatozoa.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Total or partial retrograde ejaculation
- •Major patients protected
- •Men no affiliated with a french social security regime.
结局指标
主要结局
Sperm viability: percent of live spermatozoa among 100 counted spermatozoa.
时间窗: 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.
次要结局
- Seminal biochemistry(12 months)
- spermogram(12 months)
- DNA fragmentation(12 months)
- Concomitant treatments(12 months)
- 8 Hydroxydesoxyguanosine (8OHdG)(6 months)
- Urinary and seminal infections(12 months)
- Mode of urinary catheter(12 months)
- Patient age and time to spinal cord injury(12 months)
- Sperm viability: percent of live spermatozoa among 100 counted spermatozoa.(0 months)
- elastase(18 month)
- Spinal cord injury type(0 months)