Development of a Bioabsorbable Medical Device for the Prevention of Postoperative Intra-uterine Adhesions. (PréSynUT-1)
Pathophysiology of Intrauterine Synechia - Exploratory Study. Development of a Bioabsorbable Medical Device for the Prevention of Postoperative Intra-uterine Adhesions.
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Contatti e Sedi
Luoghi di studio
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Montpellier, Francia, 34295
- CHRU de Montpellier - Hôpital Arnaud de Villeneuve
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Montpellier Cedex 05, Francia, 34093
- Institut des Biomolécules Max Mousseron
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Nîmes Cedex 09, Francia, 30029
- CHRU de Nîmes - Hôpital Universitaire Carémeau
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
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 |
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. 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 |
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. Patients will be contacted via telephone 6 months after first hysteroscopy. This intervention is required for the observational needs of this study. 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. 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 |
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. Patients will be contacted via telephone 6 months after first hysteroscopy. This intervention is required for the observational needs of this study. 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. 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Activin A
Lasso di tempo: Day 0 (day of diagnostic hysteroscopy)
|
Day 0 (day of diagnostic hysteroscopy)
|
|
Inhibin
Lasso di tempo: Day 0 (day of diagnostic hysteroscopy)
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Day 0 (day of diagnostic hysteroscopy)
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Transforming growth factor beta
Lasso di tempo: Day 0 (day of diagnostic hysteroscopy)
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Day 0 (day of diagnostic hysteroscopy)
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|
Diagnosis of synechia or other intracavitary pathology
Lasso di tempo: Day 0 (day of diagnostic hysteroscopy)
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Day 0 (day of diagnostic hysteroscopy)
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Activin A
Lasso di tempo: 1 to 2 months after diagnostic hysteroscopy (day of resection)
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1 to 2 months after diagnostic hysteroscopy (day of resection)
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|
Inhibin
Lasso di tempo: 1 to 2 months after diagnostic hysteroscopy (day of resection)
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1 to 2 months after diagnostic hysteroscopy (day of resection)
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Transforming growth factor beta
Lasso di tempo: 1 to 2 months after diagnostic hysteroscopy (day of resection)
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1 to 2 months after diagnostic hysteroscopy (day of resection)
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|
Diagnosis of synechia or other intracavitary pathology
Lasso di tempo: 1 to 2 months after diagnostic hysteroscopy (day of resection)
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1 to 2 months after diagnostic hysteroscopy (day of resection)
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|
Activin A
Lasso di tempo: 1 to 3 months after resection (day of follow-up hysteroscopy)
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1 to 3 months after resection (day of follow-up hysteroscopy)
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|
Inhibin
Lasso di tempo: 1 to 3 months after resection (day of follow-up hysteroscopy)
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1 to 3 months after resection (day of follow-up hysteroscopy)
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Transforming growth factor beta
Lasso di tempo: 1 to 3 months after resection (day of follow-up hysteroscopy)
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1 to 3 months after resection (day of follow-up hysteroscopy)
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Diagnosis of synechia or other intracavitary pathology
Lasso di tempo: 1 to 3 months after resection (day of follow-up hysteroscopy)
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1 to 3 months after resection (day of follow-up hysteroscopy)
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Pregnancy (yes/no)
Lasso di tempo: 6 months
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6 months
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- LOCAL/2013/VL-03
- 2014-A00837-40 (Altro identificatore: RCB number)
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