Ignite Creation Date:
2024-05-06 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03571776
Status:
TERMINATED
Last Update Posted:
2023-03-02
First Post:
2018-05-31
Brief Title:
Anti-mullerian Hormone AMH After Treatment of Endometriomas With Alcohol Sclerotherapy Versus Surgery Clinical Trial
Sponsor:
Hospital Universitari de Bellvitge
Organization:
Hospital Universitari de Bellvitge
Study Overview
Official Title:
Anti-mullerian Hormone in Ovarian Reserve Evaluation After Treatment of Endometriomas With Alcohol Sclerotherapy Versus Surgery Clinical Trial
Status:
TERMINATED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low recruitment because patients and gynecologists prefer the sclerosis arm to avoid surgery
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this multicenter study is to compare the ovarian reserve after alcohol sclerosis of the endometriomas against conventional surgery AMH follicle stimulating hormone FSH and antral follicles count as well as the complications and costs between the 2 procedures
Detailed Description:
Clinical Trial Phase III Multicenter National open parallel-group assignment 1 1 stratified by age previous oophorectomy and uni- or bilateral ovarian involvement Patients with suspected ovarian endometrioma by ultrasound will be randomized into 2 groups a Study Group echoguided aspiration plus sclerosis with alcohol B Control group Laparoscopic Cystectomy Pre-treatment and 6 months after treatment AMH values will be determined Complications recurrences and costs from each treatment will be collected
Study Oversight
Has Oversight DMC:
None
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?:
None