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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

NCT03227640 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-07-24

No results posted yet for this study

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.

Conditions

  • Endometrioma

Interventions

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)

Sponsors & Collaborators

  • Scientific Institute San Raffaele

    lead OTHER

Principal Investigators

  • Massimo Candiani, MD Prof · San Raffaele Scientific Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2017-08-01
Completion
2018-01-01

Countries

  • Italy
  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03227640 on ClinicalTrials.gov