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

Endometrioma Clinical Trial

— Laser  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03227640
• Other study ID #: LaserLuM
• Status: Recruiting
• Phase: N/A
• First received: July 9, 2017
• Last updated: July 20, 2017
• Start date: January 1, 2016
• Est. completion date: January 1, 2018

Study information

• Verified date: July 2017
• Source: Scientific Institute San Raffaele
• Contact: Jessica Ottolina, MD
• Email: ottolina.jessica[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2018
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis

Intervention

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.

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)

Locations

Country	Name	City	State
Italy	San Raffaele Scientific Institute	Milan
Poland	Jagiellonian University, Collegium Medicum, Cracow, Poland	Cracow

Sponsors (1)

Lead Sponsor	Collaborator
Scientific Institute San Raffaele

Countries where clinical trial is conducted

Italy,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in antral follicle count (AFC)	number of follicles with average diameter of 2-10 mm in both ovaries assessed on the second and fifth day of the menstrual cycle	baseline and 3 months
Secondary	changes in serum antimullerian hormone (AMH) levels	AMH is assessed on venous blood samples (Beckman-Coulter 2nd-generation; Gen II) obtained on day 2-5 of the menstrual cycle	baseline and 3 months