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NCT Number: NCT06045702

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

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..

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Key information

Conditions

Cystic Fibrosis Congenital Bilateral Absence of Vas Deferens Congenital bilateral aplasia of vas deferens Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Genital Diseases Genital Diseases, Male Infant, Newborn, Diseases Infertility Infertility, Male Lung Diseases Male Urogenital Diseases Pancreatic Diseases Respiratory Tract Diseases Sterility, Male Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epididymal sample

Procedure

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.

Primary outcomes

  1. 3D organisation of chromatin at the CFTR locus

    Time frame: 2 years

    Cultur Cell Model

Study contacts

Contact information is provided by the study sponsor or research team.

Antoine VALERI, MD,PhD

CONTACT

[email protected]

+33298347170

Stéphanie MOISAN, PhD

CONTACT

[email protected]

+332 98 01 65 67

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: CFTR-EP

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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