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

Not Applicable

Recruiting

• Conditions: Hysterectomy; Primary Ciliary Dyskinesia; Ectopic Pregnancy; Salpingectomy
• Interventions: Procedure: salpingectomy; Procedure: hysterectomy

• Registration Number: NCT05374720
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

Brief 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

Detailed 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

Study Timeline

• Study First Submitted: 2022-03-07
• Study First Submitted QC: 2022-05-13
• Study First Posted: 2022-05-16
• Study Start: 2022-10-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-16
• Last Update Posted: 2023-06-18
• Primary Completion: 2024-03-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Salpingectomy for Extra-Uterine Pregnancy	salpingectomy	patients with salpingectomy for Ectopic Pregnancy
hysterectomies	hysterectomy	patients with hysterectomy for prolapsus, adenomyosis or myomectomy

Primary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Intercommunal Créteil; 🇫🇷 Créteil, Val-deMarne, France