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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328742
Recruitment Status : Withdrawn (Feasibility issues require solutions.)
First Posted : December 31, 2014
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Infertility Abortion, Spontaneous Embryo Implantation, Delayed 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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pathophysiology of Intrauterine Synechia - Exploratory Study. Development of a Bioabsorbable Medical Device for the Prevention of Postoperative Intra-uterine Adhesions.
Study Start Date : November 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

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.





Primary Outcome Measures :
  1. Activin A [ Time Frame: Day 0 (day of diagnostic hysteroscopy) ]
  2. Inhibin [ Time Frame: Day 0 (day of diagnostic hysteroscopy) ]
  3. Transforming growth factor beta [ Time Frame: Day 0 (day of diagnostic hysteroscopy) ]
  4. Diagnosis of synechia or other intracavitary pathology [ Time Frame: Day 0 (day of diagnostic hysteroscopy) ]

Secondary Outcome Measures :
  1. Activin A [ Time Frame: 1 to 2 months after diagnostic hysteroscopy (day of resection) ]
  2. Inhibin [ Time Frame: 1 to 2 months after diagnostic hysteroscopy (day of resection) ]
  3. Transforming growth factor beta [ Time Frame: 1 to 2 months after diagnostic hysteroscopy (day of resection) ]
  4. Diagnosis of synechia or other intracavitary pathology [ Time Frame: 1 to 2 months after diagnostic hysteroscopy (day of resection) ]
  5. Activin A [ Time Frame: 1 to 3 months after resection (day of follow-up hysteroscopy) ]
  6. Inhibin [ Time Frame: 1 to 3 months after resection (day of follow-up hysteroscopy) ]
  7. Transforming growth factor beta [ Time Frame: 1 to 3 months after resection (day of follow-up hysteroscopy) ]
  8. Diagnosis of synechia or other intracavitary pathology [ Time Frame: 1 to 3 months after resection (day of follow-up hysteroscopy) ]
  9. Pregnancy (yes/no) [ Time Frame: 6 months ]

Biospecimen Retention:   Samples Without DNA
Endometrial biopsies.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328742


Locations
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France
Institut des Biomolécules Max Mousseron
Montpellier Cedex 05, France, 34093
CHRU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, France, 34295
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Vincent Letouzey, MD Centre Hospitalier Universitaire de Nîmes
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02328742    
Other Study ID Numbers: LOCAL/2013/VL-03
2014-A00837-40 ( Other Identifier: RCB number )
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Infertility
Abortion, Spontaneous
Pregnancy Complications