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

NCT ID: NCT03826355

Last Updated: 2019-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-05-31

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.

Conditions

Endometriosis Ovary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Stripping technique

The endometrioma is removed according to standard surgery.

Group Type: ACTIVE_COMPARATOR

Stripping technique

Intervention Type: PROCEDURE

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

Laser technique

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

Group Type: EXPERIMENTAL

CO2 (carbon dioxide) laser vaporisation

Intervention Type: PROCEDURE

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

Interventions

CO2 (carbon dioxide) laser vaporisation

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

Intervention Type: PROCEDURE

Stripping technique

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Francisco Carmona

Head of Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francisco Carmona, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Other Identifiers

OR

Identifier Type: -

Identifier Source: org_study_id