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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05374720
Other study ID # CILTUBE
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date December 31, 2024

Study information

Verified date June 2023
Source Centre Hospitalier Intercommunal Creteil
Contact Rana MITRI- FRANGIEH
Phone +33 01 57 02 22 86
Email rana.mitri-frangieh@chicreteil.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary Ciliary Dyskinesia associated with abnormalities of lateralization of organs (with existence of a situs inversus in 50% of cases) and secondary fertility disorders related in humans to abnormalities of mobility of sperm but very little data on the structure and function of tubal cilia in women


Description:

Primary Ciliary Dyskinesia (DCP) is a rare genetic disease (1 in 15,000 individuals at birth), which manifests itself in chronic respiratory infections (bronchopneumopathies and rhinosinusitis type) associated with abnormalities of lateralization of organs (with existence of a situs inversus in 50% of cases) and secondary fertility disorders related in humans to abnormalities of sperm mobility. However, there is very little data in the literature on the structure and function of tubal cilia in women with DCP. Before considering a study of tubal cilia in patients with DCP, it seems necessary to specify in DCP patients or not DCP, the molecular and morphological composition of tubal cilia and to look for ciliary abnormalities in case of GEU


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with scheduled salpingectomy (Ectopic pregnancy, hysterectomy for prolapsus, adenomyosis or myomectomy) - Major patients ( >18 years) Exclusion Criteria: - Patient not willing to participate in the study

Study Design


Intervention

Procedure:
salpingectomy
Removal of one of the fallopian tubes.
hysterectomy
remove the uterus, whole or only part. It may also involve the removal of the cervix, ovaries, fallopian tubes and other surrounding structures.

Locations

Country Name City State
France Centre Hospitalier Intercommunal Créteil Créteil Val-deMarne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary morphological of tubal cilia Molecular compositor of tubal ciliar by immunofluorescence study of 14 proteins in vivo and in vitro (tissue cells from patient fallopian tubes) through study completion, an average of 6 week after surgery
Primary Molecular difference in tubal cilia between patients with or without GEU salpingectomy compares molecular compositor of tubal ciliar by immunofluorecence study of 14 proteins in vivo and in vitro between patients with or without GEU salpingectomy through study completion, an average of 6 week after surgery
Primary molecular tubal cilia Ultrastructure morphology of tubal cell cilia by electron microscopy through study completion, an average of 6 week after surgery
Primary functional composition of tubal cell by video microscopy amplitude of moment by video microscopy through study completion, an average of 6 week after surgery
Primary functional composition of tubal cell by video microscopy frequency of moment by video microscopy through study completion, an average of 6 week after surgery
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