Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy

Hysterectomy Clinical Trial

— CILTUBE  

Official title:

Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05374720
• Other study ID #: CILTUBE
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Ciliary Motility Disorders
• Dyskinesias
• Ectopic Pregnancy
• Hysterectomy
• Pregnancy, Ectopic
• Primary Ciliary Dyskinesia
• Salpingectomy

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