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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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
Health authority
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

Study Design


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
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