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

Infertility Clinical Trial

— PréSynUT-1  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02328742
• Other study ID #: LOCAL/2013/VL-03
• Secondary ID: 2014-A00837-40
• Status: Withdrawn
• Phase: N/A
• First received: December 26, 2014
• Last updated: January 31, 2017
• Start date: November 2015
• Est. completion date: May 2018

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Embryo Implantation, Delayed
• Infertility

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHRU de Montpellier - Hôpital Arnaud de Villeneuve	Montpellier
France	Institut des Biomolécules Max Mousseron	Montpellier Cedex 05
France	CHRU 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	Activin A		Day 0 (day of diagnostic hysteroscopy)
Primary	Inhibin		Day 0 (day of diagnostic hysteroscopy)
Primary	Transforming growth factor beta		Day 0 (day of diagnostic hysteroscopy)
Primary	Diagnosis of synechia or other intracavitary pathology		Day 0 (day of diagnostic hysteroscopy)
Secondary	Activin A		1 to 2 months after diagnostic hysteroscopy (day of resection)
Secondary	Inhibin		1 to 2 months after diagnostic hysteroscopy (day of resection)
Secondary	Transforming growth factor beta		1 to 2 months after diagnostic hysteroscopy (day of resection)
Secondary	Diagnosis of synechia or other intracavitary pathology		1 to 2 months after diagnostic hysteroscopy (day of resection)
Secondary	Activin A		1 to 3 months after resection (day of follow-up hysteroscopy)
Secondary	Inhibin		1 to 3 months after resection (day of follow-up hysteroscopy)
Secondary	Transforming growth factor beta		1 to 3 months after resection (day of follow-up hysteroscopy)
Secondary	Diagnosis of synechia or other intracavitary pathology		1 to 3 months after resection (day of follow-up hysteroscopy)
Secondary	Pregnancy (yes/no)		6 months