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The Impact on Ovarian Reserve of Ovarian Cystectomy Versus Laser Vaporization in the Treatment of Ovarian Endometrioma: a Randomized Clinical Trial (Laser)

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ClinicalTrials.gov Identifier: NCT03227640
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : July 24, 2017
Sponsor:
Information provided by (Responsible Party):
Massimo Candiani, Scientific Institute San Raffaele

Brief Summary:

This is a prospective, multicentric (two centers: 1:San Raffaele Scientific institute, Milan, Italy; 2:Jagiellonian University, Collegium Medicum, Cracow, Poland), randomized (1:1) clinical trial that includes patients undergoing surgery for primary unilateral or bilateral symptomatic endometriomas.

The aim of the study is to determine whether and to what extent the two surgical procedures for endometrioma, cystectomy and laser vaporization, affect ovarian reserve. Recently, cystectomy has been questioned as an ideal surgical approach because it may involve excessive removal of ovarian tissue and the loss of follicles; laser vaporization has been proposed as a promising method to preserve ovarian function.


Condition or disease Intervention/treatment Phase
Endometrioma Procedure: stripping technique Device: CO2 laser (AcuPulse Duo, Lumenis) Not Applicable

Detailed Description:

Excisional surgery is the recommended treatment for ovarian endometrioma because of higher pregnancy rate and lower recurrence rate compared with ablative techniques. From the standpoint of ovarian reserve, the efficiency of cystectomy remains a topic of considerable debate: in recent years, cystectomy has been questioned as an ideal surgical approach for endometriomas because it is associated with excessive removal of ovarian tissue and loss of ovarian follicles with subsequent reduction of ovarian reserve. According to a recent report, absence of follicular growth was observed in 13% of operated ovaries, although this event never occurred in the contralateral gonad.

In San Raffaele Scientific Institute, fear of ovarian failure after cystectomy resulted in the introduction of an ablative technique involving CO2 laser technology, which posses the ability to deliver energy with little thermal spread. More than 80 patients were treated with CO2 laser at this Institution during three-year experience. This surgical procedure was inspired by the one employed by Jacques Donnez for more than 20 years, in which CO2 laser is used to ablate endometriomas' inner wall, after 3-months GnRHa therapy. Laser vaporization, according to the ''three-step procedure", has also been proposed as the best method to preserve ovarian function; moreover, reassuring data on the rate of long-term recurrence after laser vaporization have recently been published.

However, no data are available about the single use of CO2 laser fiber vaporization (without GnRHa therapy) with respect to the ovarian reserve.

Since 2015, the investigators have continuously evaluated the benefits of CO2 laser vaporization through a clinical trial assessing the postoperative changes in ovarian reserve as indicated by antral follicle count (AFC) and anti-mullerian hormone (AMH); the results of this pilot study support the positive effects of CO2 laser on ovarian reserve as demonstrated by higher AFC and no change in AMH at 3-month follow-up. In order to provide more conclusive data about the potential advantage of CO2 laser ablation with respect to ovarian cystectomy in terms of fertility outcomes a prospective randomized trial has been planned; the aim of this prospective randomized study is to determine whether and to what extent the two surgical procedures for ovarian endometrioma (cystectomy versus C02 laser vaporization) affect ovarian reserve.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact on Ovarian Reserve of Ovarian Cystectomy Versus Laser Vaporization in the Treatment of Ovarian Endometrioma: a Randomized Clinical Trial
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : August 1, 2017
Estimated Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: stripping
standardized laparoscopic stripping technique
Procedure: stripping technique
The cyst is stripped from the healthy ovary by traction and countertraction; after the removal of the cyst, hemostasis is achieved by selective bipolar coagulation.

Experimental: CO2 laser vaporization
drainage of the cyst content and vaporization of the internal wall with CO2 laser
Device: CO2 laser (AcuPulse Duo, Lumenis)
The cyst content is drained and the internal wall is vaporized with CO2 laser beam (AcuPulse Duo, Lumenis, Israel)




Primary Outcome Measures :
  1. changes in antral follicle count (AFC) [ Time Frame: baseline and 3 months ]
    number of follicles with average diameter of 2-10 mm in both ovaries assessed on the second and fifth day of the menstrual cycle


Secondary Outcome Measures :
  1. changes in serum antimullerian hormone (AMH) levels [ Time Frame: baseline and 3 months ]
    AMH is assessed on venous blood samples (Beckman-Coulter 2nd-generation; Gen II) obtained on day 2-5 of the menstrual cycle



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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • unilateral or bilateral endometriomas
  • pain and/or infertility associated with endometriomas
  • largest diameter of the endometrioma ≥3 cm and ≤ 8 cm

Exclusion Criteria:

  • intra-operative detection of deep infiltrating endometriosis
  • evidence of adenomyosis at the preoperative ultrasound
  • previous surgical procedures on the ovaries
  • previous unilateral oophorectomy
  • previous salpingectomy or hysterectomy
  • thyroid disease
  • hyperprolactinemia
  • diabetes mellitus
  • adrenal disorders
  • suspected or proven ovarian malignancy
  • evidence of premature ovarian failure (POF) or premature menopause
  • hormonal treatment within 3 months from baseline ovarian reserve assessment and 3 months after surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227640


Contacts
Contact: Jessica Ottolina, MD ottolina.jessica@hsr.it

Locations
Italy
San Raffaele Scientific Institute Recruiting
Milan, Italy
Contact: Jessica Ottolina, MD       ottolina.jessica@hsr.it   
Sub-Investigator: Laura M Castellano, MD         
Sub-Investigator: Jessica Ottolina, MD         
Principal Investigator: Massimo Candiani, MD Prof         
Poland
Jagiellonian University, Collegium Medicum, Cracow, Poland Recruiting
Cracow, Poland
Contact: Ewa Posadzka, ND       ewaposs@gmail.com   
Sub-Investigator: Ewa Posadzka, MD         
Sub-Investigator: Robert Jach, MD         
Sponsors and Collaborators
Scientific Institute San Raffaele
Investigators
Principal Investigator: Massimo Candiani, MD Prof San Raffaele Scientific Institute

Responsible Party: Massimo Candiani, Professor, Scientific Institute San Raffaele
ClinicalTrials.gov Identifier: NCT03227640     History of Changes
Other Study ID Numbers: LaserLuM
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female