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

Sponsor

Centre Hospitalier Intercommunal Creteil (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05374720

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Salpingectomy Hysterectomy Primary Ciliary Dyskinesia Ectopic Pregnancy	Procedure: salpingectomy Procedure: hysterectomy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Salpingectomy for Extra-Uterine Pregnancy patients with salpingectomy for Ectopic Pregnancy	Procedure: salpingectomy Removal of one of the fallopian tubes.
Sham Comparator: hysterectomies patients with hysterectomy for prolapsus, adenomyosis or myomectomy	Procedure: hysterectomy remove the uterus, whole or only part. It may also involve the removal of the cervix, ovaries, fallopian tubes and other surrounding structures.

Arm

Intervention/Treatment

Experimental: Salpingectomy for Extra-Uterine Pregnancy

patients with salpingectomy for Ectopic Pregnancy

Procedure: salpingectomy

Removal of one of the fallopian tubes.

Sham Comparator: hysterectomies

patients with hysterectomy for prolapsus, adenomyosis or myomectomy

Procedure: hysterectomy

remove the uterus, whole or only part. It may also involve the removal of the cervix, ovaries, fallopian tubes and other surrounding structures.

Outcome Measures

Primary Outcome Measures

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
molecular tubal cilia [through study completion, an average of 6 week after surgery]
Ultrastructure morphology of tubal cell cilia by electron microscopy
functional composition of tubal cell by video microscopy [through study completion, an average of 6 week after surgery]
amplitude of moment by video microscopy
functional composition of tubal cell by video microscopy [through study completion, an average of 6 week after surgery]
frequency of moment by video microscopy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Intercommunal Créteil	Créteil	Val-deMarne	France	94000

Sponsors and Collaborators

Centre Hospitalier Intercommunal Creteil

Investigators

Principal Investigator: Rana i MITRI-FRANGIEH, Centre Hospitalier Intercommunal Créteil

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Intercommunal Creteil

ClinicalTrials.gov Identifier:

NCT05374720

Other Study ID Numbers:

CILTUBE

First Posted:

May 16, 2022

Last Update Posted:

May 16, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Intercommunal Creteil

miscarriage

tubal cilia

Additional relevant MeSH terms:

Ciliary Motility Disorders

Dyskinesias

Pregnancy, Ectopic

Cardiac Complexes, Premature

Study Results

No Results Posted as of May 16, 2022