Development of a Bioabsorbable Medical Device for the Prevention of Postoperative Intra-uterine Adhesions. (PréSynUT-1)

Pathophysiology of Intrauterine Synechia - Exploratory Study. Development of a Bioabsorbable Medical Device for the Prevention of Postoperative Intra-uterine Adhesions.

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.

Study Overview

• Status: Withdrawn
• Conditions: Infertility; Abortion, Spontaneous; Embryo Implantation, Delayed
• Intervention / Treatment: Biological: Hysteroscopy + endometrial biopsy; Other: Telephone call; Biological: Resection + endometrial biopsy; Biological: Follow-up hysteroscopy + endometrial biopsy

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • CHRU de Montpellier - Hôpital Arnaud de Villeneuve
  • Montpellier Cedex 05, France, 34093
    • Institut des Biomolécules Max Mousseron
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No intracavitary pathology; During the first diagnostic hysteroscopy, patients in this group are found to not have an intracavitary pathology. (The first 20 such patients will be retained in this group.) Intervention: Hysteroscopy + endometrial biopsy Intervention: Telephone call	Biological: Hysteroscopy + endometrial biopsy; The day of the first diagnostic hysteroscopy an endometrial biopsy is performed (biopsy A1). These biopsies will be used for the evaluation of TGFbeta, Activin A and inhibin. This intervention is required for the observational needs of this study.; Other: Telephone call; Patients will be contacted via telephone 6 months after first hysteroscopy. This intervention is required for the observational needs of this study.
Synechia; During the first diagnostic hysteroscopy, patients in this group are found to have synechia. Intervention: Hysteroscopy + endometrial biopsy Intervention: Resection + endometrial biopsy Intervention: Follow-up hysteroscopy + endometrial biopsy Intervention: Telephone call	Biological: Hysteroscopy + endometrial biopsy; The day of the first diagnostic hysteroscopy an endometrial biopsy is performed (biopsy A1). These biopsies will be used for the evaluation of TGFbeta, Activin A and inhibin. This intervention is required for the observational needs of this study.; Other: Telephone call; Patients will be contacted via telephone 6 months after first hysteroscopy. This intervention is required for the observational needs of this study.; Biological: Resection + endometrial biopsy; If patients are found to have synechia or another intracavitary pathology, resection is scheduled 1-2 months later. A second endometrial biopsy is performed at this time. This intervention is required for the observational needs of this study.; Biological: Follow-up hysteroscopy + endometrial biopsy; For patients having had resection, a follow-up hysteroscopy is performed 1 to 3 months later. An endometrial biopsy will be performed at this time. This intervention is required for the observational needs of this study.
Intracavitary pathology; During the first diagnostic hysteroscopy, patients in this group are found to have an intracavitary pathology. Intervention: Hysteroscopy + endometrial biopsy Intervention: Resection + endometrial biopsy Intervention: Follow-up hysteroscopy + endometrial biopsy Intervention: Telephone call	Biological: Hysteroscopy + endometrial biopsy; The day of the first diagnostic hysteroscopy an endometrial biopsy is performed (biopsy A1). These biopsies will be used for the evaluation of TGFbeta, Activin A and inhibin. This intervention is required for the observational needs of this study.; Other: Telephone call; Patients will be contacted via telephone 6 months after first hysteroscopy. This intervention is required for the observational needs of this study.; Biological: Resection + endometrial biopsy; If patients are found to have synechia or another intracavitary pathology, resection is scheduled 1-2 months later. A second endometrial biopsy is performed at this time. This intervention is required for the observational needs of this study.; Biological: Follow-up hysteroscopy + endometrial biopsy; For patients having had resection, a follow-up hysteroscopy is performed 1 to 3 months later. An endometrial biopsy will be performed at this time. This intervention is required for the observational needs of this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Activin A	Day 0 (day of diagnostic hysteroscopy)
Inhibin	Day 0 (day of diagnostic hysteroscopy)
Transforming growth factor beta	Day 0 (day of diagnostic hysteroscopy)
Diagnosis of synechia or other intracavitary pathology	Day 0 (day of diagnostic hysteroscopy)

Secondary Outcome Measures

Outcome Measure	Time Frame
Activin A	1 to 2 months after diagnostic hysteroscopy (day of resection)
Inhibin	1 to 2 months after diagnostic hysteroscopy (day of resection)
Transforming growth factor beta	1 to 2 months after diagnostic hysteroscopy (day of resection)
Diagnosis of synechia or other intracavitary pathology	1 to 2 months after diagnostic hysteroscopy (day of resection)
Activin A	1 to 3 months after resection (day of follow-up hysteroscopy)
Inhibin	1 to 3 months after resection (day of follow-up hysteroscopy)
Transforming growth factor beta	1 to 3 months after resection (day of follow-up hysteroscopy)
Diagnosis of synechia or other intracavitary pathology	1 to 3 months after resection (day of follow-up hysteroscopy)
Pregnancy (yes/no)	6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: December 26, 2014
• First Submitted That Met QC Criteria: December 26, 2014
• First Posted (Estimate): December 31, 2014

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Infertility; Abortion, Spontaneous
• Other Study ID Numbers: LOCAL/2013/VL-03; 2014-A00837-40 (Other Identifier: RCB number)