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

Not Applicable

Completed

• Conditions: Endometriosis Ovary
• Interventions: Procedure: CO2 (carbon dioxide) laser vaporisation; Procedure: Stripping technique

• Registration Number: NCT03826355
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Primary Completion: 2017-12
• Study Completion: 2018-05
• Status Verified: 2019-01
• Study First Submitted: 2019-01-20
• Study First Submitted QC: 2019-01-30
• Last Update Submitted: 2019-01-30
• Study First Posted: 2019-02-01
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser technique	CO2 (carbon dioxide) laser vaporisation	The endometrioma is drained, everted and then the inner wall of the endometrioma is vaporised with CO2 laser
Stripping technique	Stripping technique	The endometrioma is removed according to standard surgery.

Primary Outcome Measures

Name	Time	Method
Ovarian volume	7 months	Ovarian volume will be assesses by ultrasound, units given with milliliters
Ovarian reserve	7 months	Antral follicular count by ultrasound: number of antral follicles.

Secondary Outcome Measures

Name	Time	Method
Pregnancy rate	6 months after surgery	Pregnancy rate will be recorded during the 6 months follow-up