Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy( CLESS)

NCT04178876 | Unknown

• 1 other identifier: 2690
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrioma

Keywords

endometrioma; ethanol; sclerotherapy; aspiration; ovarian reserve; endometriosis; AMH

Outcome Measures

Primary Outcomes (1)

• impact on ovarian reserve, in terms of reduction of serum AMH levels

  The AMH levels will be evaluated 1 month before the surgery and 1, 6 and 12 months after surgery.

  up to 12 months after the laparoscopy

Secondary Outcomes (2)

• endometrioma recurrence rate for the two surgical techniques

  up to 12 months after the laparoscopy

• pain relief after surgery

  up to 12 months after the laparoscopy

Study Arms (2)

Aspiration and Sclerotherapy of endometriomas

EXPERIMENTAL

Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas

Procedure: ethanol sclerotherapy

laparoscopic stripping technique

ACTIVE COMPARATOR

cystectomy of endometriomas during laparoscopy

Procedure: stripping technique

Interventions

ethanol sclerotherapy PROCEDURE

Endometrioma laparoscopic aspiration and sclerotherapy using 95% ethanol

Aspiration and Sclerotherapy of endometriomas

stripping technique PROCEDURE

Endometrioma laparoscopic cystectomy

laparoscopic stripping technique

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: This is a Gynecological study
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 30193971 BACKGROUND

• 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.

  PMID: 28579409 BACKGROUND

• 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.

  PMID: 14581861 BACKGROUND

• 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.

  PMID: 25739052 BACKGROUND

• 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.

  PMID: 30396562 BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Giovanni Scambia, MD

  Fondazione Policlinico Gemelli, IRCSS Università Cattolica del Sacro Cuore, Roma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandra De Cicco Nardone, MD

CONTACT

+393428235829; alessandradecicco@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: November 26, 2019
• Study Start: September 13, 2019
• Primary Completion: November 1, 2022
• Study Completion: June 1, 2023
• Last Updated: December 4, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: data will become available following publication.
• Access Criteria: To gain access, data requestors will need to sign a data access agreement.

Locations

IT (1)