This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05374720
Recruitment Status : Recruiting
First Posted : May 16, 2022
Last Update Posted : June 18, 2023
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal Creteil

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 1, 2022
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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)

  2. 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

  3. molecular tubal cilia [ Time Frame: through study completion, an average of 6 week after surgery ]
    Ultrastructure morphology of tubal cell cilia by electron microscopy

  4. 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

  5. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05374720


Contacts
Layout table for location contacts
Contact: Rana MITRI- FRANGIEH +33 01 57 02 22 86 rana.mitri-frangieh@chicreteil.fr
Contact: Camille Jung camille.jung@chicreteil.fr

Locations
Layout table for location information
France
Centre Hospitalier Intercommunal Créteil Recruiting
Créteil, Val-deMarne, France, 94000
Contact: Rana i MITRI-FRANGIEH    +33157022286    rana.mitri-frangieh@chicreteil.fr   
Sponsors and Collaborators
Centre Hospitalier Intercommunal Creteil
Investigators
Layout table for investigator information
Principal Investigator: Rana i MITRI-FRANGIEH Centre Hospitalier Intercommunal Créteil
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Centre Hospitalier Intercommunal Creteil
ClinicalTrials.gov Identifier: NCT05374720    
Other Study ID Numbers: CILTUBE
First Posted: May 16, 2022    Key Record Dates
Last Update Posted: June 18, 2023
Last Verified: June 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Intercommunal Creteil:
miscarriage
tubal cilia
Additional relevant MeSH terms:
Layout table for MeSH terms
Ciliary Motility Disorders
Dyskinesias
Pregnancy, Ectopic
Cardiac Complexes, Premature
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
 Cardiac Conduction System Disease
Pathologic Processes
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Ciliopathies
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases