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

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

Study Overview

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 Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Val-deMarne
      • Créteil, Val-deMarne, France, 94000
        • Centre Hospitalier Intercommunal Créteil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
morphological of tubal cilia
Time Frame: 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)
through study completion, an average of 6 week after surgery
Molecular difference in tubal cilia between patients with or without GEU salpingectomy
Time Frame: 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
through study completion, an average of 6 week after surgery
molecular tubal cilia
Time Frame: through study completion, an average of 6 week after surgery
Ultrastructure morphology of tubal cell cilia by electron microscopy
through study completion, an average of 6 week after surgery
functional composition of tubal cell by video microscopy
Time Frame: through study completion, an average of 6 week after surgery
amplitude of moment by video microscopy
through study completion, an average of 6 week after surgery
functional composition of tubal cell by video microscopy
Time Frame: through study completion, an average of 6 week after surgery
frequency of moment by video microscopy
through study completion, an average of 6 week after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2022

Primary Completion (Actual)

October 9, 2023

Study Completion (Actual)

October 9, 2023

Study Registration Dates

First Submitted

March 7, 2022

First Submitted That Met QC Criteria

May 13, 2022

First Posted (Actual)

May 16, 2022

Study Record Updates

Last Update Posted (Actual)

June 12, 2026

Last Update Submitted That Met QC Criteria

June 11, 2026

Last Verified

June 1, 2026

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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