SalpingectomyCILTUBENCT05374720
Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy
A study testing salpingectomy and hysterectomy in people with Salpingectomy and Hysterectomy, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Salpingectomy, Hysterectomy, Primary Ciliary Dyskinesia
- What is being tested?
- salpingectomy and hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 30 Nov 2022to 9 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with scheduled salpingectomy (Ectopic pregnancy, hysterectomy for prolapsus, adenomyosis or myomectomy)
- Major patients ( >18 years)
Who cannot join
- Patient not willing to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Intercommunal Créteil
Créteil, Val-deMarne, 94000
About this study
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
Read the 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
- Being tested
- salpingectomy, hysterectomy
- Keywords
- miscarriage, tubal cilia
- Medical subject headings
- Ciliary Motility Disorders, Pregnancy, Ectopic, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salpingectomyProcedure or surgery
Removal of one of the fallopian tubes.
hysterectomyProcedure or surgery
remove the uterus, whole or only part. It may also involve the removal of the cervix, ovaries, fallopian tubes and other surrounding structures.
| Study group | Role | What they receive |
|---|---|---|
| Salpingectomy for Extra-Uterine Pregnancy | Experimental | patients with salpingectomy for Ectopic Pregnancy Receives: Procedure: salpingectomy |
| hysterectomies | Sham comparator | patients with hysterectomy for prolapsus, adenomyosis or myomectomy Receives: Procedure: hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: through study completion, an average of 6 week after surgery
molecular tubal cilia
Ultrastructure morphology of tubal cell cilia by electron microscopy
Measured: through study completion, an average of 6 week after surgery
functional composition of tubal cell by video microscopy
amplitude of moment by video microscopy
Measured: through study completion, an average of 6 week after surgery
functional composition of tubal cell by video microscopy
frequency of moment by video microscopy
Measured: through study completion, an average of 6 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start30 Nov 2022
- Primary completion9 Oct 2023
- Study completion9 Oct 2023
Why it stopped: The inclusion objective was not achieved. Given the exploratory nature of the study, we have decided not to extend the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SalpingectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rana i MITRI-FRANGIEH, Principal investigator, Centre Hospitalier Intercommunal Créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374720
- Sponsor's protocol ID
- CILTUBE
- Acronym
- CILTUBE
- Status last verified
- Jun 2026
- First submitted
- 7 Mar 2022
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy
- ClinicalTrials.gov ID
- NCT05374720
- Acronym / sponsor ID
- CILTUBE / CILTUBE
- Keywords
- miscarriage, tubal cilia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The inclusion objective was not achieved. Given the exploratory nature of the study, we have decided not to extend the study
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 30 Nov 2022 (actual)
- Primary completion
- 9 Oct 2023 (actual)
- Study completion
- 9 Oct 2023 (actual)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salpingectomy for Extra-Uterine Pregnancy | Experimental | Procedure: salpingectomypatients with salpingectomy for Ectopic Pregnancy |
| hysterectomies | Sham comparator | Procedure: hysterectomypatients with hysterectomy for prolapsus, adenomyosis or myomectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with scheduled salpingectomy (Ectopic pregnancy, hysterectomy for prolapsus, adenomyosis or myomectomy)
- Major patients ( >18 years)
Key exclusion criteria (1 listed)
- Patient not willing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salpingectomyRemoval of one of the fallopian tubes. | Procedure or surgery | Salpingectomy for Extra-Uterine Pregnancy |
| hysterectomyremove the uterus, whole or only part. It may also involve the removal of the cervix, ovaries, fallopian tubes and other surrounding structures. | Procedure or surgery | hysterectomies |
Primary outcome
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
Results and safety
The study was stopped early (reason given: The inclusion objective was not achieved. Given the exploratory nature of the study, we have decided not to extend the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
Related trials for Salpingectomy
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Recruiting
Risk Reducing Salpingectomy With Delayed Oophorectomy as an Alternative to Risk- Reducing Salpingo-oophorectomy in High Risk-Women to Assess the Safety of Prevention - US Cohort Study
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruiting
Prophylactic Salpingectomy With Delayed Oophorectomy
Ovarian Carcinoma
Not yet recruiting
Standardized Educational Videos of Laparoscopic Gynecological Surgeries
Educational Problems, Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rana i MITRI-FRANGIEH principal investigator
Centre Hospitalier Intercommunal Créteil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing salpingectomy and hysterectomy in people with Salpingectomy and Hysterectomy, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The inclusion objective was not achieved. Given the exploratory nature of the study, we have decided not to extend the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morphological of tubal cilia (time frame: through study completion, an average of 6 week after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.