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

Primary Purpose

Salpingectomy, Hysterectomy, Primary Ciliary Dyskinesia

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

salpingectomy

hysterectomy

About this trial

This is an interventional other trial for Salpingectomy focused on measuring miscarriage, tubal cilia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Centre Hospitalier Intercommunal CréteilRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Salpingectomy for Extra-Uterine Pregnancy

hysterectomies

Arm Description

patients with salpingectomy for Ectopic Pregnancy

patients with hysterectomy for prolapsus, adenomyosis or myomectomy

Outcomes

Primary Outcome Measures

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)

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

molecular tubal cilia

Ultrastructure morphology of tubal cell cilia by electron microscopy

functional composition of tubal cell by video microscopy

amplitude of moment by video microscopy

functional composition of tubal cell by video microscopy

frequency of moment by video microscopy

Secondary Outcome Measures

Full Information

NCT ID

NCT05374720

First Posted

March 7, 2022

Last Updated

June 16, 2023

Sponsor

Centre Hospitalier Intercommunal Creteil

1. Study Identification

Unique Protocol Identification Number

NCT05374720

Brief Title

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

Acronym

CILTUBE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2022 (Actual)

Primary Completion Date

March 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Intercommunal Creteil

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Salpingectomy, Hysterectomy, Primary Ciliary Dyskinesia, Ectopic Pregnancy

Keywords

miscarriage, tubal cilia

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Salpingectomy for Extra-Uterine Pregnancy

Arm Type

Experimental

Arm Description

patients with salpingectomy for Ectopic Pregnancy

Arm Title

hysterectomies

Arm Type

Sham Comparator

Arm Description

patients with hysterectomy for prolapsus, adenomyosis or myomectomy

Intervention Type

Procedure

Intervention Name(s)

salpingectomy

Intervention Description

Removal of one of the fallopian tubes.

Intervention Type

Procedure

Intervention Name(s)

hysterectomy

Intervention Description

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

Primary Outcome Measure Information:

Title

morphological of tubal cilia

Description

Molecular compositor of tubal ciliar by immunofluorescence study of 14 proteins in vivo and in vitro (tissue cells from patient fallopian tubes)

Time Frame