EndometriomaCLESSNCT04178876
Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy( CLESS)
A study testing ethanol sclerotherapy and stripping technique in people with Endometrioma, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Endometrioma
- What is being tested?
- ethanol sclerotherapy and stripping technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 13 Sep 2019to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Alessandra De Cicco Nardone, MD, alessandradecicco@gmail.com
About this study
Official title: Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy: Impact on Ovarian Reserve.
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.
Read the 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.
- Conditions
- Endometrioma
- Being tested
- ethanol sclerotherapy, stripping technique
- Keywords
- endometrioma, ethanol, sclerotherapy, aspiration, ovarian reserve, endometriosis, AMH
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ethanol sclerotherapyProcedure or surgery
Endometrioma laparoscopic aspiration and sclerotherapy using 95% ethanol
stripping techniqueProcedure or surgery
Endometrioma laparoscopic cystectomy
| Study group | Role | What they receive |
|---|---|---|
| Aspiration and Sclerotherapy of endometriomas | Experimental | Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas Receives: Procedure: ethanol sclerotherapy |
| laparoscopic stripping technique | Active comparator | cystectomy of endometriomas during laparoscopy Receives: Procedure: stripping technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months after the laparoscopy
Secondary outcomes (2)
endometrioma recurrence rate for the two surgical techniques
Ultrasound examination that demonstrate the presence/lack of ovarian cyst with sonographic features of endometrioma in the ovary where the procedure took place.
Measured: up to 12 months after the laparoscopy
pain relief after surgery
The severity of pelvic pain , assessed using a visual analogue scale with no-pain classified as 0 and worst imaginable pain as 10.
Measured: up to 12 months after the laparoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start13 Sep 2019
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for EndometriomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Giovanni Scambia, Catholic University of the Sacred Heart
- Investigators
- Giovanni Scambia, MD, Principal investigator, Fondazione Policlinico Gemelli, IRCSS Università Cattolica del Sacro Cuore, Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178876
- Sponsor's protocol ID
- 2690
- Acronym
- CLESS
- Status last verified
- Dec 2019
- First submitted
- 25 Nov 2019
- Last updated
- 4 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
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.
PubMed 30193971Cohen 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.
PubMed 28579409Messalli 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.
PubMed 14581861Garcia-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.
PubMed 25739052Kovacevic 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.
PubMed 30396562
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy: Impact on Ovarian Reserve.
- ClinicalTrials.gov ID
- NCT04178876
- Acronym / sponsor ID
- CLESS / 2690
- Conditions
- Endometrioma
- Keywords
- endometrioma, ethanol, sclerotherapy, aspiration, ovarian reserve, endometriosis, AMH
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspiration and Sclerotherapy of endometriomas | Experimental | Procedure: ethanol sclerotherapyAspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas |
| laparoscopic stripping technique | Active comparator | Procedure: stripping techniquecystectomy of endometriomas during laparoscopy |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ethanol sclerotherapyEndometrioma laparoscopic aspiration and sclerotherapy using 95% ethanol | Procedure or surgery | Aspiration and Sclerotherapy of endometriomas |
| stripping techniqueEndometrioma laparoscopic cystectomy | Procedure or surgery | laparoscopic stripping technique |
Primary outcome
impact on ovarian reserve, in terms of reduction of serum AMH levels
Time frame: up to 12 months after the laparoscopy
The AMH levels will be evaluated 1 month before the surgery and 1, 6 and 12 months after surgery.
2 secondary outcomes
endometrioma recurrence rate for the two surgical techniques
Time frame: up to 12 months after the laparoscopy
pain relief after surgery
Time frame: up to 12 months after the laparoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Background: PubMed 30193971Sweed 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.
- Background: PubMed 28579409Cohen 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.
- Background: PubMed 14581861Messalli 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.
- Background: PubMed 25739052Garcia-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.
- Background: PubMed 30396562Kovacevic 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.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Scambia, MD principal investigator
Fondazione Policlinico Gemelli, IRCSS Università Cattolica del Sacro Cuore, Roma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ethanol sclerotherapy and stripping technique in people with Endometrioma, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandra De Cicco Nardone, MD (+393428235829, alessandradecicco@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
impact on ovarian reserve, in terms of reduction of serum AMH levels (time frame: up to 12 months after the laparoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04178876, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.