Clinical trial NCT04178876: Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy( CLESS)
Official title: Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy: Impact on Ovarian Reserve.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endometrioma
Keywords: endometrioma
ethanol
sclerotherapy
aspiration
ovarian reserve
endometriosis
AMH
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare two different laparoscopic surgical techniques (endometrioma stripping vs ethanol sclerotherapy) in terms of ovarian reserve (AMH levels), recurrence rate and pain relief.

Detailed description: Patients with pelvic pain (VAS score≥4) and ultrasound diagnosis of endometrioma \> 4cm candidate to surgical removal of endometrioma will be randomized into 2 group. One Group will undergo laparoscopical stripping technique; the other one will undergo laparoscopic aspiration and sclerotherapy using 95% ethanol.

The women will be introduced with both operative options and they will be informed about the randomization . After an elaborate explanation about the study they will sign an informed consent form. the following data will be collected prior the operation: age, gravity \& parity, operative history, general medical history, the cyst size, AMH (Anti Mullerian Hormone), symptoms related to endometriosis (through VAS score), fertility history including any fertility treatment in the past and planned pregnancy after the operation.

The laparoscopy will take place in Fondazione Policlinico Gemelli IRCSS, Roma. in the study group the cyst content will be aspirated and flushed with normal saline. 95% sterile ethanol will be instilled into the cyst through a Nelathon catheter. Ethanol will be left in the cyst for 15 min then aspirated as completely as possible following normal saline flushing. In the control group we will follow the standard treatment which is cystectomy.

The women will be followed at 1 , 3 , 6 and 12 months after the surgery.

Eligibility criteria: Inclusion Criteria:

* Women between 18-35 years old
* Women with ultrasound diagnosis of ovarian endometrioma ≥4cm (with or without deep infiltrating endometriosis)
* History of dysmenorrhea and/or chronic pelvic pain
* candidates for elective laparoscopy due to endometriosis.

Exclusion Criteria:

* - Previous surgery for ovarian endometriosis
* Evidence of premature ovarian failure (follicle stimulating hormone ≥40 international units/L)
* Endocrinal disorders that might affect ovarian function (e.g., polycystic ovary syndrome, thyroid dysfunction, hyperprolactinemia)
* Ultrasound suspicious of ovarian malignant disease according IOTA criteria
* endometrial cyst \< 4 cm. • ethanol sensitivity.

Primary outcomes:
measure: impact on ovarian reserve, in terms of reduction of serum AMH levels
timeFrame: up to 12 months after the laparoscopy
Secondary outcomes:
measure: endometrioma recurrence rate for the two surgical techniques
timeFrame: up to 12 months after the laparoscopy
measure: pain relief after surgery
timeFrame: up to 12 months after the laparoscopy
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Gemelli, IRCSS Università Cattolica del Sacro Cuore, Roma
name: Giovanni Scambia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sweed MS, Makled AK, El-Sayed MA, Shawky ME, Abd-Elhady HA, Mansour AM, Mohamed RM, Hemeda H, Nasr-Eldin EA, Attia NS, Eltaieb E, Allam H, Hussein A. Ovarian Reserve Following Laparoscopic Ovarian Cystectomy vs Cyst Deroofing for Endometriomas. J Minim Invasive Gynecol. 2019 Jul-Aug;26(5):877-882. doi: 10.1016/j.jmig.2018.06.022. Epub 2018 Sep 5.
citation: Cohen A, Almog B, Tulandi T. Sclerotherapy in the management of ovarian endometrioma: systematic review and meta-analysis. Fertil Steril. 2017 Jul;108(1):117-124.e5. doi: 10.1016/j.fertnstert.2017.05.015. Epub 2017 Jun 1.
citation: Messalli EM, Cobellis G, Pecori E, Pierno G, Scaffa C, Stradella L, Cobellis L. Alcohol sclerosis of endometriomas after ultrasound-guided aspiration. Minerva Ginecol. 2003 Aug;55(4):359-62.
citation: Garcia-Tejedor A, Castellarnau M, Ponce J, Fernandez ME, Burdio F. Ethanol sclerotherapy of ovarian endometrioma: a safe and effective minimal invasive procedure. Preliminary results. Eur J Obstet Gynecol Reprod Biol. 2015 Apr;187:25-9. doi: 10.1016/j.ejogrb.2015.02.004. Epub 2015 Feb 16.
citation: Kovacevic VM, Andelic LM, Mitrovic Jovanovic A. Changes in serum antimullerian hormone levels in patients 6 and 12 months after endometrioma stripping surgery. Fertil Steril. 2018 Nov;110(6):1173-1180. doi: 10.1016/j.fertnstert.2018.07.019.