Impact of Essure Tubal Sterilization Devices on the Endometrium

Sterilization, Tubal Clinical Trial

Official title:

Impact of Essure Tubal Sterilization Devices on the Endometrium

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01558882
• Other study ID #: LOCAL/2011/VL-05
• Secondary ID: 2012-A00253-40
• Status: Terminated
• Phase: N/A
• First received: March 18, 2012
• Last updated: June 16, 2017
• Start date: January 21, 2014
• Est. completion date: November 28, 2014

Study information

• Verified date: June 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: November 28, 2014
• Est. primary completion date: November 28, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Sterilization, Tubal

Intervention

Device:
• Essure
Essure devices are deployed according to manufacturer's instructions for tubal sterilization.

Locations

Country	Name	City	State
France	APHP - Hôpital Antoine Beclere	Clamart Cedex
France	APHP - Centre Hospitalier Universitaire de Bicêtre	Le Kremlin Bicêtre Cedex
France	CHRU de Montpellier - Hôpital Arnaud de Villeneuve	Montpellier
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of uNK/CD56 cells per field	Number of cells per field from endometrial biopsy	baseline (Day 0) - 3 months
Secondary	% change in IL-1 beta titration in uterine flushing sample		baseline (day 0) - 3 months
Secondary	% change in IL-12 titration in uterine flushing sample		baseline (day 0) - 3 months
Secondary	% change in IL-15 titration in uterine flushing sample		baseline (day 0) - 3 months
Secondary	% change in IL-18 titration in uterine flushing sample		baseline (day 0) - 3 months
Secondary	% change in TWEAK titration in uterine flushing sample		baseline (day 0) - 3 months
Secondary	% change in TNF-alpha titration in uterine flushing sample		baseline (day 0) - 3 months
Secondary	% change in G-CSF titration in uterine flushing sample		baseline (day 0) - 3 months
Secondary	% change in G-CSF receptor titration in uterine flushing sample		baseline (day 0) - 3 months
Secondary	% change in VEGF titration in uterine flushing sample		baseline (day 0) - 3 months
Secondary	Change in the number of macrophage cells per field on endometrial biopsy		baseline (day 0) to 3 months
Secondary	Change in the number of T cells per field on endometrial biopsy		baseline (day 0) to 3 months
Secondary	Change in expression of IL-1 beta in endometrial biopsy		baseline (day 0) to 3 months
Secondary	Change in expression of IL-12 in endometrial biopsy		baseline (day 0) to 3 months
Secondary	Change in expression of IL-15 in endometrial biopsy		baseline (day 0) to 3 months
Secondary	Change in expression of IL-18 in endometrial biopsy		baseline (day 0) to 3 months
Secondary	Change in expression of TWEAK in endometrial biopsy		baseline (day 0) to 3 months
Secondary	Change in expression of TNF-alpha in endometrial biopsy		baseline (day 0) to 3 months
Secondary	Change in expression of G-CSF in endometrial biopsy		baseline (day 0) to 3 months
Secondary	Change in expression of G-CSF receptor in endometrial biopsy		baseline (day 0) to 3 months
Secondary	Change in expression of VEGF in endometrial biopsy		baseline (day 0) to 3 months
Secondary	Change in expression of beta-2 microglobulin in endometrial biopsy		baseline (day 0) to 3 months
Secondary	Change in expression of RPL13A (reference gene) in endometrial biopsy		baseline (day 0) to 3 months
Secondary	Change in endometrial volume (cm^3)		baseline (day 0) to 3 months
Secondary	Change in subendometrial vascular flow index		baseline (day 0) to 3 months
Secondary	Time needed for Essure deployment (minutes)		baseline (day 0), immediatly after intervention
Secondary	Type of anesthesia used for Essure deployment		baseline (day 0), immediatly after intervention
Secondary	Number of spirals visible in the left uterine cavity after Essure deployment		baseline (day 0), immediatly after intervention
Secondary	Number of spirals visible in the right uterine cavity after Essure deployment		baseline (day 0), immediatly after intervention
Secondary	Presence/absence of bilateral tube obstruction		3 months
Secondary	Change in number of uNK/CD56 cells per field		2 months before intervention - Day 0