- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05374720
Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy (CILTUBE)
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Val-deMarne
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Créteil, Val-deMarne, France, 94000
- Centre Hospitalier Intercommunal Créteil
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Investigators
- Principal Investigator: Rana i MITRI-FRANGIEH, Centre Hospitalier Intercommunal Créteil
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Ciliopathies
- Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Genetic Diseases, Inborn
- Pregnancy Complications
- Respiratory Tract Diseases
- Congenital Abnormalities
- Otorhinolaryngologic Diseases
- Abnormalities, Multiple
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Abortion, Spontaneous
- Ciliary Motility Disorders
- Pregnancy, Ectopic
- Surgical Procedures, Operative
- Urogenital Surgical Procedures
- Gynecologic Surgical Procedures
- Salpingectomy
- Hysterectomy
Other Study ID Numbers
- CILTUBE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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