Clinical trial NCT02328742: Development of a Bioabsorbable Medical Device for the Prevention of Postoperative Intra-uterine Adhesions.
Official title: Pathophysiology of Intrauterine Synechia - Exploratory Study. Development of a Bioabsorbable Medical Device for the Prevention of Postoperative Intra-uterine Adhesions.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Infertility
Abortion, Spontaneous
Embryo Implantation, Delayed
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of women of childbearing age (≥18 years and \<45 years) requiring a hysteroscopy motivated by an infertility evaluation, failure of embryo implantation after invitro fertilization, repeated miscarriages

Brief summary: The main objective of this study is to describe the level of expression of the biological factors involved in the formation of adhesions (Transforming growth factor beta, Activin A, inhibin) at the time of a first diagnostic hysteroscopy among women with synechia, another intracavitary disease or no intracavitary disease.

Detailed description: The secondary obectives are:

A. For women who are found to have synechia or another intracavitary pathology at the time of resection: To describe the levels of Transforming growth factor beta, Activin A and Inhibin involved in synechia at the time of resection.

B. For women who are found to have synechia or another intracavitary pathology at the time of resection:To describe the levels of Transforming growth factor beta, Activin A and Inhibin involved in synechia at the time of a follow-up hysteroscopy following resection.

C. For women who are found to have synechia at the time of resection:To describe the change in levels of Transforming growth factor beta, Activin A and Inhibin involved at the time of a follow-up hysteroscopy following resection whether or not the patient converts back to "no synechia".

D. For women who are found to have another intracavitary pathology at the time of resection: To describe the change in levels of Transforming growth factor beta, Activin A and Inhibin involved at the time of a follow-up hysteroscopy following resection whether or not the patient converts to "synechia".

E. To estimate the intra-individual variation in the measured factors (initial biopsy levels versus levels at time of resection).

F. To create an intrauterine map of factor levels according to biopy position (riosteal / medium / proximal) for patients with synechia or another intracavitary pathology at the time of resection and then follow-up hysteroscopy.

G. To describe the levels of Transforming growth factor beta, Activin A and Inhibin as a function of pregnancy 6 months after resection.

H. Create a tissue bank associated with the study.

Eligibility criteria: Inclusion Criteria:

* The patient must be given free and informed consent and must have signed the consent form
* The patient must be affiliated with or beneficiary of a health insurance plan
* Indication for hysteroscopy associated with one of the following: infertility evaluation, postoperative dysmenorrhea, embryo implantation failure after invitro fertilization, recurrent miscarriages

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, guardianship or curatorship
* The patient refuses to sign the consent
* It is not possible to correctly inform the patient
* The patient is postmenopausal
* Indication of hysteroscopy not associated with exploration of infertility or dysmenorrhea
* Presence of endometritis objectified via sampling during diagnostic hysteroscopy

Primary outcomes:
measure: Activin A
timeFrame: Day 0 (day of diagnostic hysteroscopy)
measure: Inhibin
timeFrame: Day 0 (day of diagnostic hysteroscopy)
measure: Transforming growth factor beta
timeFrame: Day 0 (day of diagnostic hysteroscopy)
measure: Diagnosis of synechia or other intracavitary pathology
timeFrame: Day 0 (day of diagnostic hysteroscopy)
Secondary outcomes:
measure: Activin A
timeFrame: 1 to 2 months after diagnostic hysteroscopy (day of resection)
measure: Inhibin
timeFrame: 1 to 2 months after diagnostic hysteroscopy (day of resection)
measure: Transforming growth factor beta
timeFrame: 1 to 2 months after diagnostic hysteroscopy (day of resection)
measure: Diagnosis of synechia or other intracavitary pathology
timeFrame: 1 to 2 months after diagnostic hysteroscopy (day of resection)
measure: Activin A
timeFrame: 1 to 3 months after resection (day of follow-up hysteroscopy)
measure: Inhibin
timeFrame: 1 to 3 months after resection (day of follow-up hysteroscopy)
measure: Transforming growth factor beta
timeFrame: 1 to 3 months after resection (day of follow-up hysteroscopy)
measure: Diagnosis of synechia or other intracavitary pathology
timeFrame: 1 to 3 months after resection (day of follow-up hysteroscopy)
measure: Pregnancy (yes/no)
timeFrame: 6 months
Other outcomes:
Locations:
city: Montpellier Cedex 05
country: France
facility: Institut des Biomolécules Max Mousseron
city: Montpellier
country: France
facility: CHRU de Montpellier - Hôpital Arnaud de Villeneuve
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Vincent Letouzey, MD
role: PRINCIPAL_INVESTIGATOR
References: