Development of a Bioabsorbable Medical Device for the Prevention of Postoperative Intra-uterine Adhesions.

Withdrawn

• Conditions: Abortion, Spontaneous; Embryo Implantation, Delayed; Infertility

• Registration Number: NCT02328742
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Study Timeline

• Study First Submitted: 2014-12-26
• Study First Submitted QC: 2014-12-26
• Study First Posted: 2014-12-31
• Study Start: 2015-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01
• Primary Completion: 2017-11
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Activin A	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)
Transforming growth factor beta	1 to 3 months after resection (day of follow-up hysteroscopy)
Inhibin	1 to 3 months after resection (day of follow-up hysteroscopy)
Pregnancy (yes/no)	6 months

Trial Locations

Locations (3)

Institut des Biomolécules Max Mousseron; 🇫🇷 Montpellier Cedex 05, France

CHRU de Montpellier - Hôpital Arnaud de Villeneuve; 🇫🇷 Montpellier, France

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France