Gynecologic SurgeryTULIPESNCT05910385
TUbal LIgation Per Differents Endoscopic Routes and Sexuality (TULIPES)
A study testing laparoscopy and vnotes in people with Gynecologic Surgery, run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial summary
The goal of this clinical trial is compare the quality of sexual life at 6 months after tubal ligation, depending on whether it was performed by abdominal laparoscopy or by vNOTES, on the basis of a non-inferiority hypothesis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Surgery
- What is being tested?
- laparoscopy and vnotes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesFrance
- Study dates
- 23 May 2022to 18 Nov 2025
- 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
- Adult woman, eligible for tubal ligation by total salpingectomy or tubal section coagulation, sexually active at the time of inclusion
- Able to give informed consent to participate in research
- Affiliated to a social security system.
Who cannot join
- Current pregnancy or breastfeeding
- Indications of another concomitant surgical procedure (other than procedure on the appendix)
- History of upper genital infection
- Proven or suspected rectovaginal endometriosis on clinical examination
- History of rectal surgery
- Virgin patient
Show all 13Show fewer
- Any concomitant pathology deemed incompatible with the study.
- Uncured COVID or SARS-COv2 positivity dated less than 3 days prior to surgery.
- Protected adult patient, under guardianship or curatorship
- Patients not affiliated to the social security system
- Patients who do not speak French
- Patients under legal protection
- Refusal to participate.
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
CH d'Issoire
Issoire, 63500
About this study
Official title: Sexuality After Tubal Sterilization by Conventional Abdominal Laparoscopy or Vaginal Natural Orifice Transluminal Endoscopy (vNOTES) : a Randomised Controlled Trial
The goal of this clinical trial is compare the quality of sexual life at 6 months after tubal ligation, depending on whether it was performed by abdominal laparoscopy or by vNOTES, on the basis of a non-inferiority hypothesis. Participants will answer on the FSFI-19 questionnaire and quality of sexual life will be evaluated according to the score obtained at 6 months post-operative compared to pre-operative.
- Conditions
- Gynecologic Surgery
- Being tested
- laparoscopy, vnotes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopyProcedure or surgery
tubal ligation by laparoscopy or vnotes technique
vnotesProcedure or surgery
tubal ligation by laparoscopy or vnotes technique
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic | Active comparator | Not described Receives: Procedure: laparoscopy |
| vnotes | Experimental | Not described Receives: Procedure: vnotes |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of sexual life
To compare, on the basis of a non-inferiority hypothesis, the quality of sexual life at 6 months after tubal ligation, depending on whether it is performed by abdominal laparoscopy or by vNOTES, using the Female Sexual Function Index - 19 (FSFI-19) questionnaire (19 questions with 6 possible answers for each, with scores ranging from 0=worse outcome to 5=better outcome).
Measured: 6 months
Secondary outcomes (8)
characteristics of the course of surgery for tubal ligation (duration of installation and intervention in minutes)
- Compare the characteristics of the course of surgery for tubal ligation (duration of installation and intervention in minutes), depending on whether it is performed by abdominal laparoscopy or by vNOTES.
Measured: 6 months
postoperative pain
Compare the consequences of tubal ligation, depending on whether it is performed by abdominal laparoscopy or by vNOTES, in term of postoperative pain, using EVA Scale (from 0 to 10).
Measured: 6 months
consumption of peroperative analgesics.
Compare the consequences of tubal ligation, depending on whether it is performed by abdominal laparoscopy or by vNOTES, in term of consumption of peroperative analgesics (e.g. name of the analgesics, dose and duration of intake in days).
Measured: 6 months
consumption of postoperative analgesics.
Compare the consequences of tubal ligation, depending on whether it is performed by abdominal laparoscopy or by vNOTES, in term of consumption of postoperative analgesics (e.g. name of the analgesics, dose and duration of intake in days).
Measured: 6 months
per and post-operative complications
- Compare the consequences of tubal ligation, depending on whether it is performed by abdominal laparoscopy or by vNOTES, in terms of per and post-operative complications.
Measured: 6 months
patient satisfaction
- Compare the consequences of tubal ligation, depending on whether it is performed by abdominal laparoscopy or by vNOTES, in term of patient satisfaction (Very dissatisfied, Moderately dissatisfied, Neither satisfied nor dissatisfied, Moderately satisfied, Very satisfied).
Measured: 6 months
quality of life after surgery
- Compare the consequences of tubal ligation, depending on whether it is performed by abdominal laparoscopy or by vNOTES, in term of patient quality of life after surgery, using EQ-5D-5L questionnaire (with five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems).
Measured: 6 months
number of days of sick leave
- Compare the number of days of sick leave, depending on whether it is performed by abdominal laparoscopy or by vNOTES.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start23 May 2022
- Primary completion18 Nov 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, single-blind, two-parallel, bicentric therapeutic trial comparing two referenced surgical techniques
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra Curinier, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910385
- Sponsor's protocol ID
- RBHP 2021 CURINIER 2
- Other IDs
- 2021-A02263-38
- Acronym
- TULIPES
- Status last verified
- Nov 2025
- First submitted
- 25 Apr 2023
- Last updated
- 1 Dec 2025
- 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 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexuality After Tubal Sterilization by Conventional Abdominal Laparoscopy or Vaginal Natural Orifice Transluminal Endoscopy (vNOTES) : a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05910385
- Acronym / sponsor ID
- TULIPES / RBHP 2021 CURINIER 2
- Conditions
- Gynecologic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 18 Jun 2023 (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.
The goal of this clinical trial is compare the quality of sexual life at 6 months after tubal ligation, depending on whether it was performed by abdominal laparoscopy or by vNOTES, on the basis of a non-inferiority hypothesis. Participants will answer on the FSFI-19 questionnaire and quality of sexual life will be evaluated according to the score obtained at 6 months post-operative compared to pre-operative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, controlled, single-blind, two-parallel, bicentric therapeutic trial comparing two referenced surgical techniques
| Arm | Type | Receives |
|---|---|---|
| laparoscopic | Active comparator | Procedure: laparoscopy |
| vnotes | Experimental | Procedure: vnotes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult woman, eligible for tubal ligation by total salpingectomy or tubal section coagulation, sexually active at the time of inclusion
- Able to give informed consent to participate in research
- Affiliated to a social security system.
Key exclusion criteria (13 listed)
- Current pregnancy or breastfeeding
- Indications of another concomitant surgical procedure (other than procedure on the appendix)
- History of upper genital infection
- Proven or suspected rectovaginal endometriosis on clinical examination
- History of rectal surgery
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 |
|---|---|---|
| laparoscopytubal ligation by laparoscopy or vnotes technique | Procedure or surgery | laparoscopic |
| vnotestubal ligation by laparoscopy or vnotes technique | Procedure or surgery | vnotes |
Primary outcome
quality of sexual life
Time frame: 6 months
To compare, on the basis of a non-inferiority hypothesis, the quality of sexual life at 6 months after tubal ligation, depending on whether it is performed by abdominal laparoscopy or by vNOTES, using the Female Sexual Function Index - 19 (FSFI-19) questionnaire (19 questions with 6 possible answers for each, with scores ranging from 0=worse outcome to 5=better outcome).
8 secondary outcomes
characteristics of the course of surgery for tubal ligation (duration of installation and intervention in minutes)
Time frame: 6 months
postoperative pain
Time frame: 6 months
consumption of peroperative analgesics.
Time frame: 6 months
consumption of postoperative analgesics.
Time frame: 6 months
per and post-operative complications
Time frame: 6 months
patient satisfaction
Time frame: 6 months
quality of life after surgery
Time frame: 6 months
number of days of sick leave
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
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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.
Sandra Curinier principal investigator
University Hospital, Clermont-Ferrand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopy and vnotes in people with Gynecologic Surgery, run by University Hospital, Clermont-Ferrand at 2 sites 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
quality of sexual life (time frame: 6 months). 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 1 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.