Sterilization, TubalNCT01558882
Impact of Essure Tubal Sterilization Devices on the Endometrium
An observational study of Sterilization, Tubal, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.
Trial summary
The mobilization of natural killer cells (uNK) triggers and coordinates all stages of embryo implantation. They are at the origin of the local secretion of cytokines, growth factors, chemokines affecting vascular development and the local immunotrophisme for the conceptus. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Sterilization, Tubal
- What is being tested?
- Essure
- Type of treatment
- Medical device
- How many people
- 2 participants
- Where
- 4 sitesFrance
- Study dates
- 21 Jan 2014to 28 Nov 2014
- Phase
- Observational
- 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 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Ten women desiring tubal sterilization via the ESSURE method.
Who may be able to join
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 3 months of follow up
- The patient has had at least one child
- The patient desires definitive tubal sterilization via the ESSURE technique
- The legal delay of 4 months between request for sterilization and surgery has been respected
- Local contraception (condom or spermicide) must be used for three months before and after tubal sterilization
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant, parturient, or breastfeeding
Show all 14Show fewer
- The patient had a diagnosed pregnancy (this includes pregnancies lost or interruptions in the 2nd or 3rd trimester) within the 4 months before ESSURE implants
- The patient has a contraindication for a treatment used in this study
- The patient uses one of the following types of contraception: intrauterine device; oestroprogestatif (pill).
- Endometriosis
- Gynecological infection
- adenomyosis
- uterine polyp
- uterine surgery
Trial locations and contacts
4 sites in 1 country.
France4 sites
APHP - Hôpital Antoine Beclere
Clamart, 92141
APHP - Centre Hospitalier Universitaire de Bicêtre
Le Kremlin-Bicêtre, 94275
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, 34295
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029
About this study
The mobilization of natural killer cells (uNK) triggers and coordinates all stages of embryo implantation. They are at the origin of the local secretion of cytokines, growth factors, chemokines affecting vascular development and the local immunotrophisme for the conceptus. The main objective of this study is to evaluate the expression of endometrial uNK cells before and after tubal obstruction by Essure devices. Endoluminal and endometrial levels of various cytokines and growth factors will also be studied.
- Conditions
- Sterilization, Tubal
- Being tested
- Essure
- Keywords
- Essure, Change in uterine cytokines, Change in uterine natural killer cells, cytokine, natural killer cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EssureDevice
Essure devices are deployed according to manufacturer's instructions for tubal sterilization.
| Study group | Role | What they receive |
|---|---|---|
| 10 patients | The patients included desire tubal sterilization via the ESSURE technique. Receives: Device: Essure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of uNK/CD56 cells per field
Number of cells per field from endometrial biopsy
Measured: baseline (Day 0) - 3 months
Secondary outcomes (30)
% change in IL-1 beta titration in uterine flushing sample
Measured: baseline (day 0) - 3 months
% change in IL-12 titration in uterine flushing sample
Measured: baseline (day 0) - 3 months
% change in IL-15 titration in uterine flushing sample
Measured: baseline (day 0) - 3 months
% change in IL-18 titration in uterine flushing sample
Measured: baseline (day 0) - 3 months
% change in TWEAK titration in uterine flushing sample
Measured: baseline (day 0) - 3 months
% change in TNF-alpha titration in uterine flushing sample
Measured: baseline (day 0) - 3 months
% change in G-CSF titration in uterine flushing sample
Measured: baseline (day 0) - 3 months
% change in G-CSF receptor titration in uterine flushing sample
Measured: baseline (day 0) - 3 months
% change in VEGF titration in uterine flushing sample
Measured: baseline (day 0) - 3 months
Change in the number of macrophage cells per field on endometrial biopsy
Measured: baseline (day 0) to 3 months
Change in the number of T cells per field on endometrial biopsy
Measured: baseline (day 0) to 3 months
Change in expression of IL-1 beta in endometrial biopsy
Measured: baseline (day 0) to 3 months
Change in expression of IL-12 in endometrial biopsy
Measured: baseline (day 0) to 3 months
Change in expression of IL-15 in endometrial biopsy
Measured: baseline (day 0) to 3 months
Change in expression of IL-18 in endometrial biopsy
Measured: baseline (day 0) to 3 months
Change in expression of TWEAK in endometrial biopsy
Measured: baseline (day 0) to 3 months
Change in expression of TNF-alpha in endometrial biopsy
Measured: baseline (day 0) to 3 months
Change in expression of G-CSF in endometrial biopsy
Measured: baseline (day 0) to 3 months
Change in expression of G-CSF receptor in endometrial biopsy
Measured: baseline (day 0) to 3 months
Change in expression of VEGF in endometrial biopsy
Measured: baseline (day 0) to 3 months
Change in expression of beta-2 microglobulin in endometrial biopsy
Measured: baseline (day 0) to 3 months
Change in expression of RPL13A (reference gene) in endometrial biopsy
Measured: baseline (day 0) to 3 months
Change in endometrial volume (cm^3)
Measured: baseline (day 0) to 3 months
Change in subendometrial vascular flow index
Measured: baseline (day 0) to 3 months
Time needed for Essure deployment (minutes)
Measured: baseline (day 0), immediatly after intervention
Type of anesthesia used for Essure deployment
Measured: baseline (day 0), immediatly after intervention
Number of spirals visible in the left uterine cavity after Essure deployment
Measured: baseline (day 0), immediatly after intervention
Number of spirals visible in the right uterine cavity after Essure deployment
Measured: baseline (day 0), immediatly after intervention
Presence/absence of bilateral tube obstruction
Measured: 3 months
Change in number of uNK/CD56 cells per field
Measured: 2 months before intervention - Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study start21 Jan 2014
- Primary completion28 Nov 2014
- Study completion28 Nov 2014
Why it stopped: Trouble with recruting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sterilization, TubalStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Letouzey, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558882
- Sponsor's protocol ID
- LOCAL/2011/VL-05
- Other IDs
- 2012-A00253-40
- Status last verified
- Jun 2017
- First submitted
- 18 Mar 2012
- Last updated
- 19 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Essure Tubal Sterilization Devices on the Endometrium
- ClinicalTrials.gov ID
- NCT01558882
- Acronym / sponsor ID
- LOCAL/2011/VL-05
- Conditions
- Sterilization, Tubal
- Keywords
- Essure, Change in uterine cytokines, Change in uterine natural killer cells, cytokine, natural killer cell
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Trouble with recruting
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 21 Jan 2014 (actual)
- Primary completion
- 28 Nov 2014 (actual)
- Study completion
- 28 Nov 2014 (actual)
- First posted
- 20 Mar 2012 (estimated)
- 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 mobilization of natural killer cells (uNK) triggers and coordinates all stages of embryo implantation. They are at the origin of the local secretion of cytokines, growth factors, chemokines affecting vascular development and the local immunotrophisme for the conceptus. The main objective of this study is to evaluate the expression of endometrial uNK cells before and after tubal obstruction by Essure devices. Endoluminal and endometrial levels of various cytokines and growth factors will also be studied.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 10 patients | – | Device: EssureThe patients included desire tubal sterilization via the ESSURE technique. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ten women desiring tubal sterilization via the ESSURE method.
Key inclusion criteria (7 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 3 months of follow up
- The patient has had at least one child
- The patient desires definitive tubal sterilization via the ESSURE technique
Key exclusion criteria (14 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
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 |
|---|---|---|
| EssureEssure devices are deployed according to manufacturer's instructions for tubal sterilization. | Device | 10 patients |
Primary outcome
Change in number of uNK/CD56 cells per field
Time frame: baseline (Day 0) - 3 months
Number of cells per field from endometrial biopsy
30 secondary outcomes
% change in IL-1 beta titration in uterine flushing sample
Time frame: baseline (day 0) - 3 months
% change in IL-12 titration in uterine flushing sample
Time frame: baseline (day 0) - 3 months
% change in IL-15 titration in uterine flushing sample
Time frame: baseline (day 0) - 3 months
% change in IL-18 titration in uterine flushing sample
Time frame: baseline (day 0) - 3 months
% change in TWEAK titration in uterine flushing sample
Time frame: baseline (day 0) - 3 months
% change in TNF-alpha titration in uterine flushing sample
Time frame: baseline (day 0) - 3 months
% change in G-CSF titration in uterine flushing sample
Time frame: baseline (day 0) - 3 months
% change in G-CSF receptor titration in uterine flushing sample
Time frame: baseline (day 0) - 3 months
% change in VEGF titration in uterine flushing sample
Time frame: baseline (day 0) - 3 months
Change in the number of macrophage cells per field on endometrial biopsy
Time frame: baseline (day 0) to 3 months
Change in the number of T cells per field on endometrial biopsy
Time frame: baseline (day 0) to 3 months
Change in expression of IL-1 beta in endometrial biopsy
Time frame: baseline (day 0) to 3 months
Change in expression of IL-12 in endometrial biopsy
Time frame: baseline (day 0) to 3 months
Change in expression of IL-15 in endometrial biopsy
Time frame: baseline (day 0) to 3 months
Change in expression of IL-18 in endometrial biopsy
Time frame: baseline (day 0) to 3 months
Change in expression of TWEAK in endometrial biopsy
Time frame: baseline (day 0) to 3 months
Change in expression of TNF-alpha in endometrial biopsy
Time frame: baseline (day 0) to 3 months
Change in expression of G-CSF in endometrial biopsy
Time frame: baseline (day 0) to 3 months
Change in expression of G-CSF receptor in endometrial biopsy
Time frame: baseline (day 0) to 3 months
Change in expression of VEGF in endometrial biopsy
Time frame: baseline (day 0) to 3 months
Change in expression of beta-2 microglobulin in endometrial biopsy
Time frame: baseline (day 0) to 3 months
Change in expression of RPL13A (reference gene) in endometrial biopsy
Time frame: baseline (day 0) to 3 months
Change in endometrial volume (cm^3)
Time frame: baseline (day 0) to 3 months
Change in subendometrial vascular flow index
Time frame: baseline (day 0) to 3 months
Time needed for Essure deployment (minutes)
Time frame: baseline (day 0), immediatly after intervention
Type of anesthesia used for Essure deployment
Time frame: baseline (day 0), immediatly after intervention
Number of spirals visible in the left uterine cavity after Essure deployment
Time frame: baseline (day 0), immediatly after intervention
Number of spirals visible in the right uterine cavity after Essure deployment
Time frame: baseline (day 0), immediatly after intervention
Presence/absence of bilateral tube obstruction
Time frame: 3 months
Change in number of uNK/CD56 cells per field
Time frame: 2 months before intervention - Day 0
Results and safety
The study was stopped early (reason given: Trouble with recruting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2017.
Related trials for Sterilization, Tubal
Recruiting
Patient-centered Information on Permanent Contraception
Contraception, Reproductive Behavior
Recruiting
Assessment of Tubal Occlusion During Minimally Invasive Myomectomy
Fallopian Tube Patency Tests, Fibroid/Myoma (Uterus/Cervix)
Active, not recruiting
SALpingectomy for STERilization (SALSTER)
Sterilization Tubal, Salpingectomy
Enrolling by invitationObservational study
Stop Ovarian Cancer Young; Effect of the Opportunistic Salpingectomy on Age of Menopause
Salpingectomy, Tubal Ligation
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.
Vincent Letouzey, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sterilization, Tubal, run by Centre Hospitalier Universitaire de Nīmes at 4 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 7 inclusion and 14 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 19 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 was stopped early (reason given: Trouble with recruting). 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?
Change in number of uNK/CD56 cells per field (time frame: baseline (Day 0) - 3 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 19 Jun 2017.