Clinical Trials Directory

Trials / Completed

CompletedNCT04073888

Study of the Spermatic Characteristics of Patients With Fabry Disease

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
22 (actual)
Sponsor
University Hospital, Bordeaux · Academic / Other
Sex
Male
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

The objective of this project is to estimate the prevalence of spermatic abnormalities in patients with Fabry disease.The main objective of this project is to estimate the prevalence of spermatic abnormalities in patients with Fabry disease.

Detailed description

Fabry disease is a lysosomal storage burden of X-linked genetic transmission due to alpha-galactosidase deficiency. This enzyme deficiency causes deposits of globotriaosylceramide in virtually all cell types of the body. The majority of hemizygous men develop a severe multisystemic disease dominated by renal failure, neurological and cardiac involvement. There is a specific treatment based on enzyme replacement therapy. The incidence of Fabry disease is estimated between 1/60000 and 1/3500 in the general population. Infertility in Fabry disease is poorly documented. Only a few cases have been reported, from alteration of spermogram to azoospermia. The identification of deposits suggestive of Gb3 in light microscopy and electron microscopy at the level of the genital tract argues in favor of the attack of this device. The low prevalence of Fabry disease requires a cross-sectional multicenter study to determine the frequency of alterations in sperm characteristics, their impact on fertility, and the possible effect of substitution therapy, in order to establish appropriate measures. adequate preventive measures. The objective of this project is to estimate the prevalence of spermatic abnormalities in patients with Fabry disease.The main objective of this project is to estimate the prevalence of spermatic abnormalities in patients with Fabry disease.

Conditions

Interventions

TypeNameDescription
PROCEDURESemen collectionSemen collection for seminogram and spermocytogram

Timeline

Start date
2009-02-20
Primary completion
2013-10-18
Completion
2013-10-18
First posted
2019-08-29
Last updated
2019-08-29

Source: ClinicalTrials.gov record NCT04073888. Inclusion in this directory is not an endorsement.