NCT03826355

Brief Summary

Endometriosis is a disease characterized by the presence of endometrial tissue outside the uterus cavity, causing important chronic pain and sterility in those patients suffering from it. It affects from 10 to 20% of women at reproductive age. Different types of endometriosis, which can coexist in the same patient, exist: deep infiltrating endometriosis (implants infiltrate \> 5 mm the peritoneum), superficial endometriosis and ovarian endometriosis (OMA). OMA sometimes require surgery, and it is known that healthy ovarian tissue is also injured during resection. Consequently, ovarian reserve decreases, worsening the reproductive prognosis of patients affected. The main objective of the present study is to compare laser versus conventional OMA excision according to ovarian reserve in a pairwise-data study.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

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, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

January 20, 2019

Last Update Submit

January 30, 2019

Conditions

Endometriosis Ovary

Outcome Measures

Primary Outcomes (2)

  • Ovarian reserve

    Antral follicular count by ultrasound: number of antral follicles.

    7 months

  • Ovarian volume

    Ovarian volume will be assesses by ultrasound, units given with milliliters

    7 months

Secondary Outcomes (1)

  • Pregnancy rate

    6 months after surgery

Study Arms (2)

Stripping technique

ACTIVE COMPARATOR

The endometrioma is removed according to standard surgery.

Procedure: Stripping technique

Laser technique

EXPERIMENTAL

The endometrioma is drained, everted and then the inner wall of the endometrioma is vaporised with CO2 laser

Procedure: CO2 (carbon dioxide) laser vaporisation

Interventions

CO2 (carbon dioxide) laser vaporisationPROCEDURE

CO2 (carbon dioxide) laser is used to vaporise the inner wall of the endometrioma

Laser technique
Stripping techniquePROCEDURE

Identification of a cleavage plane and perform the cystectomy removing all the wall of the endometrioma from the healthy ovarian tissue

Stripping technique

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 45.
  • Bilateral endometriomas.
  • Endometrioma size \> 3 cm.
  • Pain and/or infertility as indication to surgical treatment.

You may not qualify if:

  • History of cancer.
  • Suspected malignancy.
  • Evidence of premature ovarian failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Carbon Dioxide

Intervention Hierarchy (Ancestors)

Carbon Compounds, InorganicInorganic ChemicalsGasesOxidesOxygen Compounds

Study Officials

  • Francisco Carmona, MD PhD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
The ultrasonographer will be blinded to the procedure performed in each ovary after surgery. The patient will not be told which procedure has been performed in each ovary. The investigator will not know which procedure has been performed in each ovary until the end of the study. Only the surgeon will know which procedure is performed in each ovary.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized prospective pairwise-data study. Patients with bilateral endometrioma with surgical indication will be selected. Ovarian reserve will be evaluated before and after surgery in both ovaries separately, using antral follicle count (AFC) and volume measurement. Type of surgery in each ovary will be randomized in the operating room (standard cystectomy vs laser vaporisation). A blinded ultrasonographer will evaluate AFC and volume measurement in both ovaries, before and three and six months after surgery. Therefore, each ovary will be compared with its contralateral in the same patient.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Gynecology

Study Record Dates

First Submitted

January 20, 2019

First Posted

February 1, 2019

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

May 1, 2018

Last Updated

February 1, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share