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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00837-40 | Other Identifier | RCB number |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hysteroscopy + endometrial biopsy | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Activin A | Day 0 (day of diagnostic hysteroscopy) | |
| Inhibin | Day 0 (day of diagnostic hysteroscopy) | |
| Transforming growth factor beta | Day 0 (day of diagnostic hysteroscopy) | |
| Diagnosis of synechia or other intracavitary pathology | Day 0 (day of diagnostic hysteroscopy) |
| Measure | Description | Time Frame |
|---|---|---|
| Activin A | 1 to 2 months after diagnostic hysteroscopy (day of resection) | |
| Inhibin | 1 to 2 months after diagnostic hysteroscopy (day of resection) | |
| Transforming growth factor beta |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Letouzey, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut des Biomolécules Max Mousseron | Montpellier | 34093 | France | |||
| CHRU de Montpellier - Hôpital Arnaud de Villeneuve |
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Endometrial biopsies.
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| Telephone call | Other | Patients will be contacted via telephone 6 months after first hysteroscopy. This intervention is required for the observational needs of this study. |
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| Resection + endometrial biopsy | Biological | 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. |
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| Follow-up hysteroscopy + endometrial biopsy | Biological | 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. |
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| 1 to 2 months after diagnostic hysteroscopy (day of resection) |
| Diagnosis of synechia or other intracavitary pathology | 1 to 2 months after diagnostic hysteroscopy (day of resection) |
| Activin A | 1 to 3 months after resection (day of follow-up hysteroscopy) |
| Inhibin | 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) |
| Diagnosis of synechia or other intracavitary pathology | 1 to 3 months after resection (day of follow-up hysteroscopy) |
| Pregnancy (yes/no) | 6 months |
| Montpellier |
| 34295 |
| France |
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| ID | Term |
|---|---|
| D007246 | Infertility |
| D000022 | Abortion, Spontaneous |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D015907 | Hysteroscopy |
| ID | Term |
|---|---|
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013513 | Obstetric Surgical Procedures |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
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