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

• ClinicalTrials.gov Identifier: NCT05374720
• Recruitment Status: Recruiting
• First Posted: May 16, 2022
• Last Update Posted: June 18, 2023
• Sponsor: Centre Hospitalier Intercommunal Creteil
• Information provided by (Responsible Party): Centre Hospitalier Intercommunal Creteil

Tracking Information

• First Submitted Date: March 7, 2022
• First Posted Date: May 16, 2022
• Last Update Posted Date: June 18, 2023
• Actual Study Start Date: October 1, 2022
• Estimated Primary Completion Date: March 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 13, 2022)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy
• Official Title: Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy
• 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

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other

Condition

• Salpingectomy
• Hysterectomy
• Primary Ciliary Dyskinesia
• Ectopic Pregnancy

Intervention

• Procedure: salpingectomy
  Removal of one of the fallopian tubes.
• 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.

Study Arms

• Experimental: Salpingectomy for Extra-Uterine Pregnancy
  patients with salpingectomy for Ectopic Pregnancy
  Intervention: Procedure: salpingectomy
• Sham Comparator: hysterectomies
  patients with hysterectomy for prolapsus, adenomyosis or myomectomy
  Intervention: Procedure: hysterectomy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 13, 2022): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2024
• Estimated Primary Completion Date: March 31, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Rana MITRI- FRANGIEH; +33 01 57 02 22 86; rana.mitri-frangieh@chicreteil.fr

Contact: Camille Jung; camille.jung@chicreteil.fr

• Listed Location Countries: France

Administrative Information

• NCT Number: NCT05374720
• Other Study ID Numbers: CILTUBE
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Centre Hospitalier Intercommunal Creteil
• Original Responsible Party: Same as current
• Current Study Sponsor: Centre Hospitalier Intercommunal Creteil
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Centre Hospitalier Intercommunal Creteil
• Verification Date: June 2023