Conservative Endometrioma Surgery

Not Applicable

Recruiting

• Conditions: Endometrioma; Endometriosis Ovary
• Interventions: Procedure: Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).

• Registration Number: NCT04151433
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

To study which surgical technique offers better results in treating endometriomas in terms of ovarian reserve preservation.

The 2 conservatives techniques used are:

1. The combined technique

2. CO2 laser vaporization only

Ovarian reserve will be assessed by consecutive measurements of AMH serum levels before and after surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-24
• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-10-31
• Study First Posted: 2019-11-05
• Status Verified: 2024-12
• Primary Completion: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-10
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 92

Inclusion Criteria

• Age: 18 - 40 years (both inclusive)
• Unilateral endometriotic cysts with a mean diameter of >=2.5cm and ≤8 cm, measured in 3 dimensions.
• Presence of a contralateral endometrioma of ≤ 2cm is allowed
• Complaining of infertility and/or pain
• BMI ≤35
• Use of contraception (combined or Progesteron only) for at least 4 weeks before surgery

Exclusion Criteria

• Incomplete surgery for the pelvis
• Contra-indication for the use of contraception (combined or Progesteron only)
• Use of GnRH analogues preoperatively and in the first 3 months postoperatively
• (History of) hysterectomy
• Prior unilateral oophorectomy
• Pituitary/hypothalamic disorders
• Suspected malignancy
• Contralateral endometrioma of >2 cm
• AMH <0.7 preoperatively
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
The combined technique	Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).	First step consisting of stripping the cyst wall for 80% of the surface, followed by a second step consisting of ablation of the remaining 20% cyst surface.
CO2 laser vaporization only	Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).	CO2 laser vaporization only of the complete inner cystic wall after drainage of the cyst content, irrigation and inspection of its inner wall. Ablation of the inner cyst wall using the CO2 laser (Lumenis). Power settings of 30-55W for CO2 laser beam and 6-10W for CO2 fibre are used. The laser should be on the ablate function to widen the beam (e.g. Surgitouch modus). The laser should be applied in Surgitouch modus so that it can ablate the cyst surface while preserving the underlying healthy tissue.

Primary Outcome Measures

Name	Time	Method
AMH levels 3 months postoperatively	3 months postoperatively	To assess the effect of conservative laparoscopic treatment of endometrioma(s) on ovarian reserve as reflected by AMH in patients planned for laparoscopic CO2 laser surgery. For the primary outcome evaluation of serum AMH will be done before (baseline) and after (at 3 months follow up) laparoscopic treatment of endometrioma(s).

Trial Locations

Locations (4)

GZA Sint-Augustinus; 🇧🇪 Antwerp, Belgium

Cliniques universitaires Saint-LUC (UCL); 🇧🇪 Brussel, Belgium

CHR La Citadelle; 🇧🇪 Liège, Belgium

UZLeuven; 🇧🇪 Leuven, Belgium