Establishment of a Primary Epididymal Cell Model From Epididymal Samples to Study CFTR Gene Regulation (CFTR-EP)
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| ClinicalTrials.gov Identifier: NCT06045702 |
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Recruitment Status :
Not yet recruiting
First Posted : September 21, 2023
Last Update Posted : September 25, 2023
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Sponsor:
University Hospital, Brest
Information provided by (Responsible Party):
University Hospital, Brest
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Brief 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..
| Condition or disease | Intervention/treatment |
|---|---|
| Cystic Fibrosis Congenital Bilateral Absence of Vas Deferens Sterility, Male | Procedure: Epididymal sample |
| Study Type : | Observational |
| Estimated Enrollment : | 20 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | Establishment of a Primary Epididymal Cell Model From Epididymal Samples to Study CFTR Gene Regulation |
| Estimated Study Start Date : | September 2023 |
| Estimated Primary Completion Date : | September 2025 |
| Estimated Study Completion Date : | September 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Cystic fibrosis
| Group/Cohort | Intervention/treatment |
|---|---|
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Group control
Adult patients with no genetic pathology other than male infertility of any type leading to an inability to procreate without medical assistance, and requiring surgery to recover spermatozoa for possible in vitro fertilization.
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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. |
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CFTR-associated pathology
Major patients with cystic fibrosis or male infertility due to agenesis of the vas deferens. These patients will be included in the study because they have the prospect of procreation by in vitro fertilisation requiring surgery to recover spermatozoa.
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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. |
Primary Outcome Measures :
- 3D organisation of chromatin at the CFTR locus [ Time Frame: 2 years ]Cultur Cell Model
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
The target population for this study will be adult male patients with all types of male infertility due to genital defects, including epididymal defects due to obstruction or agenesis of the vas deferens, cystic fibrosis or male infertility due to bilateral agenesis of the vas deferens.
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045702
Contacts
| Contact: Antoine VALERI, MD,PhD | +33298347170 | Antoine.Valeri@univ-brest.fr | |
| Contact: Stéphanie MOISAN, PhD | +332 98 01 65 67 | stephanie.moisan@chu-brest.fr |
Locations
| France | |
| Antoine VALERI | |
| Brest, France, 29200 | |
| Contact: Antoine VALERI, MD,PhD +33298347170 Antoine.Valeri@univ-brest.fr | |
Sponsors and Collaborators
University Hospital, Brest
Investigators
| Principal Investigator: | Antoine VALERI, MD,PhD | University Hospital, Brest |
| Responsible Party: | University Hospital, Brest |
| ClinicalTrials.gov Identifier: | NCT06045702 |
| Other Study ID Numbers: |
29BRC22.0273 |
| First Posted: | September 21, 2023 Key Record Dates |
| Last Update Posted: | September 25, 2023 |
| Last Verified: | September 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | All collected data that underlie results in a publication |
| Supporting Materials: |
Study Protocol |
| Time Frame: | Data will be available beginning three years and ending fifteen years following the final study report completion. |
| Access Criteria: | Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by University Hospital, Brest:
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Infertility Primary epididymal cells |
Additional relevant MeSH terms:
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Cystic Fibrosis Infertility Infertility, Male Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases |
Genetic Diseases, Inborn Infant, Newborn, Diseases Genital Diseases Urogenital Diseases Genital Diseases, Male Male Urogenital Diseases |