Chelsea and Westminster NHS Foundation Trust
London, SW10 9NH, United Kingdom
Location status: Recruiting
NCT Number: NCT06775769
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.
Interested in participating?
Request Info18 year–45 year
Female
Interventional
Not applicable
London, SW10 9NH, United Kingdom
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Laparoscopic ethanol sclerotherapy of endometrioma
Routine surgical management of endometrioma
Time frame: 24 months
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
Time frame: 24 monhts
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
Time frame: 24 monhts
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
Time frame: 24 monhts
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
Contact information is provided by the study sponsor or research team.
Sarah Bennet, BSc MBBS MRCOG
CONTACT
Thomas Bainton, BM BCh MRCOG MA(Oxon)
CONTACT
Chelsea and Westminster NHS Foundation Trust
Other
Endometrioma Sclerotherapy and Ovarian Preservation: a Randomised Control Trial of Laparoscopic Sclerotherapy vs Traditional Excision of Endometrioma
Acronym: ENDOSAVE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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