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

Centre Hospitalier Universitaire de Nīmes

Status: Withdrawn

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

Treatments: Other: Telephone call; Biological: Follow-up hysteroscopy + endometrial biopsy; Biological: Resection + endometrial biopsy; Biological: Hysteroscopy + endometrial biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT02328742

LOCAL/2013/VL-03

2014-A00837-40 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 44 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 3 patient groups

No intracavitary pathology

Description:

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

Treatment:

Biological: Hysteroscopy + endometrial biopsy

Other: Telephone call

Synechia

Description:

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

Treatment:

Biological: Resection + endometrial biopsy

Biological: Follow-up hysteroscopy + endometrial biopsy

Biological: Hysteroscopy + endometrial biopsy

Other: Telephone call

Intracavitary pathology

Description:

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

Treatment:

Biological: Resection + endometrial biopsy

Biological: Follow-up hysteroscopy + endometrial biopsy

Biological: Hysteroscopy + endometrial biopsy

Other: Telephone call