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

Cystic Fibrosis Clinical Trial

— CFTR-EP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06045702
• Other study ID #: 29BRC22.0273
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: September 2025

Study information

• Verified date: September 2023
• Source: University Hospital, Brest
• Contact: Antoine VALERI, MD,PhD
• Phone: +33298347170
• Email: Antoine.Valeri[@]univ-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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..

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Infertility
• Infertility, Male

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	Antoine VALERI	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3D organisation of chromatin at the CFTR locus	Cultur Cell Model	2 years