Fertility of Spinal Cord Injured Men

NCT02144558 | Completed

• 1 other identifier: P130703
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Sperm Parameters of Spinal Cord Injured Men

Keywords

Sperm parameters; Spinal cord injuries; Oxidative stress; Inflammatory syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (39)

• spermogram

  18 months

• elastase

  6 month

• DNA fragmentation

  18 months

• 8 Hydroxydesoxyguanosine (8OHdG)

  18 months

• Seminal biochemistry

  18 months

Study Arms (1)

Spinal cord injured (SCI) men, para or tetraplegic

EXPERIMENTAL

SCI men will have 4 medical visits associated to sperm retrieval (penile vibratory stimulation (PVS) or masturbation)

Other: penile vibratory stimulation (PVS) or masturbation

Interventions

penile vibratory stimulation (PVS) or masturbation OTHER

penile vibratory stimulation (PVS) or masturbation

Spinal cord injured (SCI) men, para or tetraplegic

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Agence de La Biomédecine: collaborator
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

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

Paris, 75014, France

Location

Related Publications (4)

• Chalas C, Jilet L, Wolf JP, Drouineaud V, Abdoul H, Patrat C, Denys P, Giuliano F. Prospective analysis over time of semen parameters in spinal cord-injured patients: Results of a pilot study. Andrology. 2022 Jan;10(1):120-127. doi: 10.1111/andr.13089. Epub 2021 Aug 13.

  PMID: 34347944 BACKGROUND

• 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.

  PMID: 20850834 BACKGROUND

• 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.

  PMID: 9176453 BACKGROUND

• 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.

  PMID: 17804864 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

poliovirus receptor

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Céline Chalas, PhD

  Cochin Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: May 22, 2014
• Study Start: April 24, 2014
• Primary Completion: April 5, 2018
• Study Completion: April 5, 2018
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

FR (1)