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Clinical Trials in France / NCT06045702
Recruiting Observational

Establishment of a Primary Epididymal Cell Model From Epididymal Samples to Study CFTR Gene Regulation

NCT06045702 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-09-11
Last updated
2026-03-20

Condition(s) studied

Cystic FibrosisCongenital Bilateral Absence of Vas DeferensSterility, Male

Investigational drug(s) / intervention(s)

Epididymal sample

Epididymal sample: During a planned surgical procedure carried out by the Urology and Medically Assisted Reproduction (MAP) department at Brest University Hospital in the patients included in the study, a remnant epididymal sample (between ½ and ¼ of a cc) will be kept for research purposes. These patients suffer from male infertility, leading them to undergo surgery in order to check for the presence of spermatozoa in the epididymis, and to recover spermatozoa which will be frozen and flaked in the AMP department of the CHU Brest, in the event of future procreation by in vitro fertilisation.

Study summary

The aim of this observational study is to better understand the role and involvement of the regulatory elements of the CFTR gene, with the aim of better describing the 3D organisation of chromatin at the CFTR locus in epididymal cells in patients with male infertility of any kind, or with cystic fibrosis or bilateral agenesis of the vas deferens, requiring scheduled surgery.

The main questions it aims to answer are:

* to better characterise this 3D organisation of the CFTR locus, the study of regulatory elements in primary epididymal cells is the most relevant and realistic model.
* to gain a better understanding of the regulation of the CFTR gene in epididymal cells in order to gain a better understanding of the pathology of male infertility caused by bilateral agenesis of the vas deferens, a symptom and also a borderline form of cystic fibrosis.

Participants will Epididymal samples will be taken by a urologist for the AMP department during the planned surgery. The rest of the samples taken will be recovered for research purposes, with the aim of recovering the epididymal cells contained in the sample. This is in no way an additional procedure and will have no impact on the patient's health..

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Male patients over 18 years of age * Patients, without genetic pathology, scheduled for epididymal sampling surgery * Patients with cystic fibrosis or bilateral vas deferens agenesis, scheduled for epididymal sampling surgery. * Signature of a consent form Exclusion Criteria: * Patients not scheduled for epididymal harvesting surgery * Patients under legal protection (guardianship, curatorship) * Refusal to participate

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Antoine VALERI Brest France Recruiting

More University Hospital, Brest trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06045702 on ClinicalTrials.gov ↗ ← All trials in France