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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Management of Endometrioma | Other | Routine Care |
|
| Laparoscopic Sclerotherapy | Experimental | Laparoscopic ethanol sclerotherapy of endometrioma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sclerotherapy | Procedure | Laparoscopic ethanol sclerotherapy of endometrioma |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Ovarian Reserve | To determine the statistical difference in ovarian reserve pre- and post- treatment (as measured by serum AMH at 3, 6, 12 and 24 months and antral follicle count at 6, 12 and 24 months) in participants randomised to receive laparoscopic ethanol sclerotherapy or laparoscopic excision of endometrioma | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Endometrioma recurrence | To determine if laparoscopic ethanol sclerotherapy for ovarian endometrioma alters recurrence of ovarian endometrioma (as measured by TVUSS at 6, 12 and 24 months) as compared to laparoscopic excision of endometrioma | 24 monhts |
| Symptomatology |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Bennet, BSc MBBS MRCOG | Contact | 07983980924 | sarah.bennet25@imperial.ac.uk | |
| Thomas Bainton, BM BCh MRCOG MA(Oxon) | Contact | tombainton@doctors.org.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chelsea and Westminster NHS Foundation Trust | Recruiting | London | SW10 9NH | United Kingdom |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015911 | Sclerotherapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Randomised control trial
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Ultra-sonographer
| Routine Care |
| Procedure |
Routine surgical management of endometrioma |
|
To determine if laparoscopic ethanol sclerotherapy for ovarian endometrioma affects symptomatology (as recorded by EHP-30) as compared to laparoscopic excision of endometrioma at 3, 6, 12 and 24 months |
| 24 monhts |
| Inflammation | To determine if laparoscopic ethanol sclerotherapy for ovarian endometrioma alters the inflammatory environment (as measured in blood at 3, 6, 12 and 24 months, and endometrial biopsy at 6 months) as compared to laparoscopic excision of endometrioma | 24 monhts |
| D000091662 | Genital Diseases |