Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy
CILTUBE
1 other identifier
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2022
CompletedFirst Posted
Study publicly available on registry
May 16, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJune 18, 2023
June 1, 2023
1.5 years
March 7, 2022
June 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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)
through study completion, an average of 6 week after surgery
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
through study completion, an average of 6 week after surgery
molecular tubal cilia
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
amplitude of moment by video microscopy
through study completion, an average of 6 week after surgery
functional composition of tubal cell by video microscopy
frequency of moment by video microscopy
through study completion, an average of 6 week after surgery
Study Arms (2)
Salpingectomy for Extra-Uterine Pregnancy
EXPERIMENTALpatients with salpingectomy for Ectopic Pregnancy
hysterectomies
SHAM COMPARATORpatients with hysterectomy for prolapsus, adenomyosis or myomectomy
Interventions
Removal of one of the fallopian tubes.
remove the uterus, whole or only part. It may also involve the removal of the cervix, ovaries, fallopian tubes and other surrounding structures.
Eligibility Criteria
You may qualify if:
- Patients with scheduled salpingectomy (Ectopic pregnancy, hysterectomy for prolapsus, adenomyosis or myomectomy)
- Major patients ( \>18 years)
You may not qualify if:
- Patient not willing to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Intercommunal Créteil
Créteil, Val-deMarne, 94000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rana i MITRI-FRANGIEH
Centre Hospitalier Intercommunal Créteil
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2022
First Posted
May 16, 2022
Study Start
October 1, 2022
Primary Completion
March 31, 2024
Study Completion
December 31, 2024
Last Updated
June 18, 2023
Record last verified: 2023-06