NCT03227640

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 9, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 24, 2017

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

July 24, 2017

Status Verified

July 1, 2017

Enrollment Period

1.6 years

First QC Date

July 9, 2017

Last Update Submit

July 20, 2017

Conditions

Endometrioma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • changes in serum antimullerian hormone (AMH) levels

    baseline and 3 months

Study Arms (2)

stripping

ACTIVE COMPARATOR

standardized laparoscopic stripping technique

Procedure: stripping technique

CO2 laser vaporization

EXPERIMENTAL

drainage of the cyst content and vaporization of the internal wall with CO2 laser

Device: CO2 laser (AcuPulse Duo, Lumenis)

Interventions

stripping techniquePROCEDURE

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.

stripping
CO2 laser (AcuPulse Duo, Lumenis)DEVICE

The cyst content is drained and the internal wall is vaporized with CO2 laser beam (AcuPulse Duo, Lumenis, Israel)

CO2 laser vaporization

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

San Raffaele Scientific Institute

Milan, Italy

RECRUITING

Jagiellonian University, Collegium Medicum, Cracow, Poland

Krakow, Poland

RECRUITING

Related Publications (1)

  • Candiani M, Ottolina J, Posadzka E, Ferrari S, Castellano LM, Tandoi I, Pagliardini L, Nocun A, Jach R. Assessment of ovarian reserve after cystectomy versus 'one-step' laser vaporization in the treatment of ovarian endometrioma: a small randomized clinical trial. Hum Reprod. 2018 Dec 1;33(12):2205-2211. doi: 10.1093/humrep/dey305.

    PMID: 30299482DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

Lasers, Gas

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Massimo Candiani, MD Prof

    San Raffaele Scientific Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Ottolina, MD

CONTACT

ottolina.jessica@hsr.it

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

July 9, 2017

First Posted

July 24, 2017

Study Start

January 1, 2016

Primary Completion

August 1, 2017

Study Completion

January 1, 2018

Last Updated

July 24, 2017

Record last verified: 2017-07

Locations

PL(1)IT(1)