Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis Ovary
• Intervention / Treatment: Procedure: Stripping technique; Procedure: CO2 (carbon dioxide) laser vaporisation

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stripping technique; The endometrioma is removed according to standard surgery.	Procedure: Stripping technique; Identification of a cleavage plane and perform the cystectomy removing all the wall of the endometrioma from the healthy ovarian tissue
Experimental: Laser technique; The endometrioma is drained, everted and then the inner wall of the endometrioma is vaporised with CO2 laser	Procedure: CO2 (carbon dioxide) laser vaporisation; CO2 (carbon dioxide) laser is used to vaporise the inner wall of the endometrioma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy rate	Pregnancy rate will be recorded during the 6 months follow-up	6 months after surgery

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Principal Investigator: Francisco Carmona, MD PhD, Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: January 20, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Actual): February 1, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: OR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No