Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
Study NCT ID:
NCT06775769
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2024-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endometrioma Sclerotherapy and Ovarian Preservation
Sponsor:
Chelsea and Westminster NHS Foundation Trust
Organization:
Study Overview
Official Title:
Endometrioma Sclerotherapy and Ovarian Preservation: a Randomised Control Trial of Laparoscopic Sclerotherapy vs Traditional Excision of Endometrioma
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
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:
ENDOSAVE
Brief Summary:
A randomised controlled trial assessing ovarian reserve after laparoscopic ethanol sclerotherapy of ovarian endometrioma compared to standard treatment of surgical excision of endometrioma.
Secondary outcomes will include endometrioma recurrence, symptomatology and inflammatory environment.
Secondary outcomes will include endometrioma recurrence, symptomatology and inflammatory environment.
Detailed Description:
Participants with endometrioma(ta), identified on imaging, who are opting for surgical management of endometriosis will be randomly allocated to laparoscopic ethanol sclerotherapy of endometrioma or laparoscopic surgical excision of endometrioma(ta). Any concurrent endometriosis identified at surgery will be excised as per routine care.
Ovarian reserve will be assessed by serum anti-Mullarian hormone (AMH) and antral follicle count (AFC), recurrence will me assessed by transvaginal ultrasound, symptomatology will be assessed by EHP-30 questionnaires and changes in inflammation assessed in serum and endometrial biopsy.
Each participant will be followed up for a total of 24 months from surgery.
Ovarian reserve will be assessed by serum anti-Mullarian hormone (AMH) and antral follicle count (AFC), recurrence will me assessed by transvaginal ultrasound, symptomatology will be assessed by EHP-30 questionnaires and changes in inflammation assessed in serum and endometrial biopsy.
Each participant will be followed up for a total of 24 months from surgery.
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?: