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OpenTrials
Completed

NCT Number: NCT02144558

Fertility of Spinal Cord Injured Men

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

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Key information

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique-Hôpitaux de Paris, Cochin Hospital, Department of Biology of Reproduction

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Total or partial retrograde ejaculation
  • Major patients protected
  • Men no affiliated with a french social security regime.

Treatment and study plan

penile vibratory stimulation (PVS) or masturbation

Other

penile vibratory stimulation (PVS) or masturbation

Primary outcomes

  1. 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.

Secondary outcomes

  1. spermogram

    Time frame: 18 months

    Sperm concentration, mobility and morphology

  2. elastase

    Time frame: 6 month

    Measure of inflammation

  3. DNA fragmentation

    Time frame: 18 months

    Sperm DNA integrity, measures oxidative stress

  4. 8 Hydroxydesoxyguanosine (8OHdG)

    Time frame: 18 months

    Oxydative stress

  5. Seminal biochemistry

    Time frame: 18 months

    Secretion of seminal tract

  6. Urinary and seminal infections

    Time frame: 18 months

    Bacteriological analysis of sperm and urine

  7. Mode of urinary catheter

    Time frame: 18 months

  8. Spinal cord injury type

    Time frame: 0 months

    Type and level of the lesion

  9. Concomitant treatments

    Time frame: 18 months

  10. Patient age and time to spinal cord injury

    Time frame: 18 months

  11. Sperm viability: percent of live spermatozoa among 100 counted spermatozoa.

    Time frame: 6 months

    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.

  12. Sperm viability: percent of live spermatozoa among 100 counted spermatozoa.

    Time frame: 12 months

    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.

  13. Sperm viability: percent of live spermatozoa among 100 counted spermatozoa.

    Time frame: 0 months

    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.

  14. elastase

    Time frame: 0 month

    Measure of inflammation

  15. elastase

    Time frame: 12 month

    Measure of inflammation

  16. elastase

    Time frame: 18 month

    Measure of inflammation

  17. spermogram

    Time frame: 0 months

    Sperm concentration, mobility and morphology

  18. spermogram

    Time frame: 6 months

    Sperm concentration, mobility and morphology

  19. spermogram

    Time frame: 12 months

    Sperm concentration, mobility and morphology

  20. DNA fragmentation

    Time frame: 0 month

    Sperm DNA integrity, measures oxidative stress

  21. DNA fragmentation

    Time frame: 6 months

    Sperm DNA integrity, measures oxidative stress

  22. DNA fragmentation

    Time frame: 12 months

    Sperm DNA integrity, measures oxidative stress

  23. 8 Hydroxydesoxyguanosine (8OHdG)

    Time frame: 0 months

    Oxydative stress

  24. 8 Hydroxydesoxyguanosine (8OHdG)

    Time frame: 6 months

    Oxydative stress

  25. Seminal biochemistry

    Time frame: 0 months

    Secretion of seminal tract

  26. Seminal biochemistry

    Time frame: 6 months

    Secretion of seminal tract

  27. Seminal biochemistry

    Time frame: 12 months

    Secretion of seminal tract

  28. Urinary and seminal infections

    Time frame: 0 months

    Bacteriological analysis of sperm and urine

  29. Urinary and seminal infections

    Time frame: 6 months

    Bacteriological analysis of sperm and urine

  30. Urinary and seminal infections

    Time frame: 12 months

    Bacteriological analysis of sperm and urine

  31. Mode of urinary catheter

    Time frame: 0 months

  32. Mode of urinary catheter

    Time frame: 6 months

  33. Mode of urinary catheter

    Time frame: 12 months

  34. Concomitant treatments

    Time frame: 0 month

  35. Concomitant treatments

    Time frame: 6 months

  36. Concomitant treatments

    Time frame: 12 months

  37. Patient age and time to spinal cord injury

    Time frame: 0 month

  38. Patient age and time to spinal cord injury

    Time frame: 6 months

  39. Patient age and time to spinal cord injury

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Agence de La Biomédecine
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Evolution of Sperm Parameters and Study of Risk Factors of Impairment of Sperm Quality in Spinal Cord Injuries. Longitudinal Prospective Study.

Acronym: FertiSCI

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
May 22, 2014
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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