Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-01-11 @ 4:37 PM
Study NCT ID:
NCT03351205
Status:
UNKNOWN
Last Update Posted:
2017-11-22
First Post:
2017-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Estrogen Therapy Against Adhesion Reformation After Hysteroscopic Adhesiolysis
Sponsor:
Beijing Obstetrics and Gynecology Hospital
Organization:
Study Overview
Official Title:
Randomized, Controlled Trial to Assess the Efficacy of Estrogen Therapy Combined With Disposable Balloon Uterine Stent and Dried Biological Amnion Graft in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
Status:
UNKNOWN
Status Verified Date:
2017-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. Intrauterine balloon has been used for the prevention of intrauterine adhesions. It has been reported that dried biological amnion graft was used to prevent adhesion after the operation of intrauterine adhesions. Estrogen is also used for postoperative prevention of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Disposable balloon uterine stent，which is an innovative intrauterine balloon，is specially designed to fit into the cavity of the uterus. Does Disposable balloon uterine stent and amniotic products combine estrogen therapy improve clinical outcomes? Therefore, this study was conducted.
Detailed Description:
Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double (participant and outcomes Assessor) Primary Purpose: Prevention
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: