Fertility of Spinal Cord Injured Men (FertiSCI)
Primary Purpose
Sperm Parameters of Spinal Cord Injured Men
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
penile vibratory stimulation (PVS) or masturbation
Sponsored by
About this trial
This is an interventional prevention trial for Sperm Parameters of Spinal Cord Injured Men focused on measuring Sperm parameters, Spinal cord injuries, Oxidative stress, Inflammatory syndrome
Eligibility Criteria
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.
Sites / Locations
- Assistance Publique-Hôpitaux de Paris, Cochin Hospital, Department of Biology of Reproduction
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Spinal cord injured (SCI) men, para or tetraplegic
Arm Description
SCI men will have 4 medical visits associated to sperm retrieval (penile vibratory stimulation (PVS) or masturbation)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
spermogram
Sperm concentration, mobility and morphology
elastase
Measure of inflammation
DNA fragmentation
Sperm DNA integrity, measures oxidative stress
8 Hydroxydesoxyguanosine (8OHdG)
Oxydative stress
Seminal biochemistry
Secretion of seminal tract
Urinary and seminal infections
Bacteriological analysis of sperm and urine
Mode of urinary catheter
Spinal cord injury type
Type and level of the lesion
Concomitant treatments
Patient age and time to spinal cord injury
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.
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.
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.
elastase
Measure of inflammation
elastase
Measure of inflammation
elastase
Measure of inflammation
spermogram
Sperm concentration, mobility and morphology
spermogram
Sperm concentration, mobility and morphology
spermogram
Sperm concentration, mobility and morphology
DNA fragmentation
Sperm DNA integrity, measures oxidative stress
DNA fragmentation
Sperm DNA integrity, measures oxidative stress
DNA fragmentation
Sperm DNA integrity, measures oxidative stress
8 Hydroxydesoxyguanosine (8OHdG)
Oxydative stress
8 Hydroxydesoxyguanosine (8OHdG)
Oxydative stress
Seminal biochemistry
Secretion of seminal tract
Seminal biochemistry
Secretion of seminal tract
Seminal biochemistry
Secretion of seminal tract
Urinary and seminal infections
Bacteriological analysis of sperm and urine
Urinary and seminal infections
Bacteriological analysis of sperm and urine
Urinary and seminal infections
Bacteriological analysis of sperm and urine
Mode of urinary catheter
Mode of urinary catheter
Mode of urinary catheter
Concomitant treatments
Concomitant treatments
Concomitant treatments
Patient age and time to spinal cord injury
Patient age and time to spinal cord injury
Patient age and time to spinal cord injury
Full Information
NCT ID
NCT02144558
First Posted
May 19, 2014
Last Updated
April 16, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Agence de La Biomédecine
1. Study Identification
Unique Protocol Identification Number
NCT02144558
Brief Title
Fertility of Spinal Cord Injured Men
Acronym
FertiSCI
Official Title
Evolution of Sperm Parameters and Study of Risk Factors of Impairment of Sperm Quality in Spinal Cord Injuries. Longitudinal Prospective Study.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 24, 2014 (Actual)
Primary Completion Date
April 5, 2018 (Actual)
Study Completion Date
April 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Agence de La Biomédecine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sperm Parameters of Spinal Cord Injured Men
Keywords
Sperm parameters, Spinal cord injuries, Oxidative stress, Inflammatory syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spinal cord injured (SCI) men, para or tetraplegic
Arm Type
Experimental
Arm Description
SCI men will have 4 medical visits associated to sperm retrieval (penile vibratory stimulation (PVS) or masturbation)
Intervention Type
Other
Intervention Name(s)
penile vibratory stimulation (PVS) or masturbation
Intervention Description
penile vibratory stimulation (PVS) or masturbation
Primary Outcome Measure Information:
Title
Sperm viability: percent of live spermatozoa among 100 counted spermatozoa.
Description
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.
Time Frame
18 month
Secondary Outcome Measure Information:
Title
spermogram
Description
Sperm concentration, mobility and morphology
Time Frame
18 months
Title
elastase
Description
Measure of inflammation
Time Frame
6 month
Title
DNA fragmentation
Description
Sperm DNA integrity, measures oxidative stress
Time Frame
18 months
Title
8 Hydroxydesoxyguanosine (8OHdG)
Description
Oxydative stress
Time Frame
18 months
Title
Seminal biochemistry
Description
Secretion of seminal tract
Time Frame
18 months
Title
Urinary and seminal infections
Description
Bacteriological analysis of sperm and urine
Time Frame
18 months
Title
Mode of urinary catheter
Time Frame
18 months
Title
Spinal cord injury type
Description
Type and level of the lesion
Time Frame
0 months
Title
Concomitant treatments
Time Frame
18 months
Title
Patient age and time to spinal cord injury
Time Frame
18 months
Title
Sperm viability: percent of live spermatozoa among 100 counted spermatozoa.
Description
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.
Time Frame
6 months
Title
Sperm viability: percent of live spermatozoa among 100 counted spermatozoa.
Description
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.
Time Frame
12 months
Title
Sperm viability: percent of live spermatozoa among 100 counted spermatozoa.
Description
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.
Time Frame
0 months
Title
elastase
Description
Measure of inflammation
Time Frame
0 month
Title
elastase
Description
Measure of inflammation
Time Frame
12 month
Title
elastase
Description
Measure of inflammation
Time Frame
18 month
Title
spermogram
Description
Sperm concentration, mobility and morphology
Time Frame
0 months
Title
spermogram
Description
Sperm concentration, mobility and morphology
Time Frame
6 months
Title
spermogram
Description
Sperm concentration, mobility and morphology
Time Frame
12 months
Title
DNA fragmentation
Description
Sperm DNA integrity, measures oxidative stress
Time Frame
0 month
Title
DNA fragmentation
Description
Sperm DNA integrity, measures oxidative stress
Time Frame
6 months
Title
DNA fragmentation
Description
Sperm DNA integrity, measures oxidative stress
Time Frame
12 months
Title
8 Hydroxydesoxyguanosine (8OHdG)
Description
Oxydative stress
Time Frame
0 months
Title
8 Hydroxydesoxyguanosine (8OHdG)
Description
Oxydative stress
Time Frame
6 months
Title
Seminal biochemistry
Description
Secretion of seminal tract
Time Frame
0 months
Title
Seminal biochemistry
Description
Secretion of seminal tract
Time Frame
6 months
Title
Seminal biochemistry
Description
Secretion of seminal tract
Time Frame
12 months
Title
Urinary and seminal infections
Description
Bacteriological analysis of sperm and urine
Time Frame
0 months
Title
Urinary and seminal infections
Description
Bacteriological analysis of sperm and urine
Time Frame
6 months
Title
Urinary and seminal infections
Description
Bacteriological analysis of sperm and urine
Time Frame
12 months
Title
Mode of urinary catheter
Time Frame
0 months
Title
Mode of urinary catheter
Time Frame
6 months
Title
Mode of urinary catheter
Time Frame
12 months
Title
Concomitant treatments
Time Frame
0 month
Title
Concomitant treatments
Time Frame
6 months
Title
Concomitant treatments
Time Frame
12 months
Title
Patient age and time to spinal cord injury
Time Frame
0 month
Title
Patient age and time to spinal cord injury
Time Frame
6 months
Title
Patient age and time to spinal cord injury
Time Frame
12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Céline Chalas, PhD
Organizational Affiliation
Cochin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique-Hôpitaux de Paris, Cochin Hospital, Department of Biology of Reproduction
City
Paris
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
20850834
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.
Results Reference
background
PubMed Identifier
9176453
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. doi: 10.1016/s0015-0282(97)81448-3.
Results Reference
background
PubMed Identifier
17804864
Citation
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. doi: 10.2164/jandrol.107.003574. Epub 2007 Sep 5.
Results Reference
background
Learn more about this trial
Fertility of Spinal Cord Injured Men
We'll reach out to this number within 24 hrs