NCT02328742

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

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Infertility
• Abortion, Spontaneous
• Embryo Implantation, Delayed

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-11-01
• Completion: 2018-05-01
• First posted: 2014-12-31
• Last updated: 2017-02-01

Locations

3 sites across 1 country: France