TerminatedNot Applicable

Study of the Spermatic Characteristics of Patients With Fabry Disease

Stopped: target number of subjects not reached

France22 participantsStarted 2009-02-20

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * male patients with Fabry disease regardless of the clinical form of the disease; treated with enzyme replacement therapy or not (from the initial diagnosis). The definite diagnosis of Fabry disease will be established on the deficit of the activity of alpha galactosidase A (\<12%). A molecular genetic study is desirable but not mandatory, * patients aged 18 to 65, * giving their free and informed consent to participate, after information on the research. Exclusion Criteria: * persons placed under the protection of justice, * unaffiliated or non-beneficiary subject of a social security scheme.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

volume (ml) of sperm

Timeframe: At Day 1

pH of sperm

Timeframe: At Day 1

Count (million / ml) of spermatozoids

Timeframe: At Day 1

Mobility (%) and mobility type of spermatozoa according to WHO classification of spermatozoids

Timeframe: At Day 1

Total number of spermatozoa in one ejaculate

Timeframe: At Day 1

Total number of progressive motile spermatozoa

Timeframe: At Day 1

Existence of leukospermia yes/no

Timeframe: At Day 1

% of typical forms of spermatozoids

Timeframe: At Day 1

Trial details

NCT IDNCT04073888

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-10-18

View on ClinicalTrials.gov More Fabry Disease trials

Who can participate

Age range

18 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

volume (ml) of sperm

Timeframe: At Day 1

pH of sperm

Timeframe: At Day 1

Count (million / ml) of spermatozoids

Timeframe: At Day 1

Mobility (%) and mobility type of spermatozoa according to WHO classification of spermatozoids

Timeframe: At Day 1

Total number of spermatozoa in one ejaculate

Timeframe: At Day 1

Total number of progressive motile spermatozoa

Timeframe: At Day 1

Existence of leukospermia yes/no

Timeframe: At Day 1

% of typical forms of spermatozoids

Timeframe: At Day 1