Pathophysiology of Intrauterine Synechia - Exploratory Study. Development of a Bioabsorbable Medical Device for the Prevention of Postoperative Intra-uterine Adhesions.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 3
- 主要终点
- Activin A
研究概览
简要总结
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.
详细描述
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".
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Activin A
时间窗: Day 0 (day of diagnostic hysteroscopy)
Transforming growth factor beta
时间窗: Day 0 (day of diagnostic hysteroscopy)
Inhibin
时间窗: Day 0 (day of diagnostic hysteroscopy)
Diagnosis of synechia or other intracavitary pathology
时间窗: Day 0 (day of diagnostic hysteroscopy)
次要结局
- Activin A(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))
- Transforming growth factor beta(1 to 3 months after resection (day of follow-up hysteroscopy))
- Inhibin(1 to 3 months after resection (day of follow-up hysteroscopy))
- Pregnancy (yes/no)(6 months)