Fertility of Spinal Cord Injured Men

Sperm Parameters of Spinal Cord Injured Men Clinical Trial

— FertiSCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02144558
• Other study ID #: P130703
• Status: Completed
• Phase: N/A
• Start date: April 24, 2014
• Est. completion date: April 5, 2018

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 5, 2018
• Est. primary completion date: April 5, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sperm Parameters of Spinal Cord Injured Men
• Spinal Cord Injuries

Intervention

Other:
• penile vibratory stimulation (PVS) or masturbation
penile vibratory stimulation (PVS) or masturbation

Locations

Country	Name	City	State
France	Assistance Publique-Hôpitaux de Paris, Cochin Hospital, Department of Biology of Reproduction	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Agence de La Biomédecine

Country where clinical trial is conducted

France, 

References & Publications (3)

Brackett 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. Epub 2007 Sep 5. — View Citation

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. — View Citation

Padron 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 month
Secondary	spermogram	Sperm concentration, mobility and morphology	18 months
Secondary	elastase	Measure of inflammation	6 month
Secondary	DNA fragmentation	Sperm DNA integrity, measures oxidative stress	18 months
Secondary	8 Hydroxydesoxyguanosine (8OHdG)	Oxydative stress	18 months
Secondary	Seminal biochemistry	Secretion of seminal tract	18 months
Secondary	Urinary and seminal infections	Bacteriological analysis of sperm and urine	18 months
Secondary	Mode of urinary catheter		18 months
Secondary	Spinal cord injury type	Type and level of the lesion	0 months
Secondary	Concomitant treatments		18 months
Secondary	Patient age and time to spinal cord injury		18 months
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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.	0 months
Secondary	elastase	Measure of inflammation	0 month
Secondary	elastase	Measure of inflammation	12 month
Secondary	elastase	Measure of inflammation	18 month
Secondary	spermogram	Sperm concentration, mobility and morphology	0 months
Secondary	spermogram	Sperm concentration, mobility and morphology	6 months
Secondary	spermogram	Sperm concentration, mobility and morphology	12 months
Secondary	DNA fragmentation	Sperm DNA integrity, measures oxidative stress	0 month
Secondary	DNA fragmentation	Sperm DNA integrity, measures oxidative stress	6 months
Secondary	DNA fragmentation	Sperm DNA integrity, measures oxidative stress	12 months
Secondary	8 Hydroxydesoxyguanosine (8OHdG)	Oxydative stress	0 months
Secondary	8 Hydroxydesoxyguanosine (8OHdG)	Oxydative stress	6 months
Secondary	Seminal biochemistry	Secretion of seminal tract	0 months
Secondary	Seminal biochemistry	Secretion of seminal tract	6 months
Secondary	Seminal biochemistry	Secretion of seminal tract	12 months
Secondary	Urinary and seminal infections	Bacteriological analysis of sperm and urine	0 months
Secondary	Urinary and seminal infections	Bacteriological analysis of sperm and urine	6 months
Secondary	Urinary and seminal infections	Bacteriological analysis of sperm and urine	12 months
Secondary	Mode of urinary catheter		0 months
Secondary	Mode of urinary catheter		6 months
Secondary	Mode of urinary catheter		12 months
Secondary	Concomitant treatments		0 month
Secondary	Concomitant treatments		6 months
Secondary	Concomitant treatments		12 months
Secondary	Patient age and time to spinal cord injury		0 month
Secondary	Patient age and time to spinal cord injury		6 months
Secondary	Patient age and time to spinal cord injury		12 months