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NCT02144558: FertiSCI
Fertility of Spinal Cord Injured Men
NA trial testing penile vibratory stimulation (PVS) or masturbation in Sperm Parameters of Spinal Cord Injured Men in 35 participants. Completed in 5 April 2018.
5 April 2018
Quick facts
| Lead sponsor | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 35 |
| Start date | 24 April 2014 |
| Primary completion | 5 April 2018 |
| Estimated completion | 5 April 2018 |
| Sites | 1 location across France |
Drugs / interventions tested
- penile vibratory stimulation (PVS) or masturbation
Conditions studied
- Sperm Parameters of Spinal Cord Injured Men — all drugs for Sperm Parameters of Spinal Cord Injured Men →
Sponsor
Assistance Publique - Hôpitaux de Paris — full company profile →
Who can join
Adults 18 to 60, male only, with Sperm Parameters of Spinal Cord Injured Men. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02144558
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02144558 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
- Last refreshed: 11 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02144558.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing