Conservative Endometrioma Surgery

NCT04151433 | Recruiting DMC

• 1 other identifier: S62899
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 4

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. 1.The combined technique
2. 2.CO2 laser vaporization only

Conditions

Endometriosis Ovary; Endometrioma

Outcome Measures

Primary Outcomes (1)

• AMH levels 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).

  3 months postoperatively

Study Arms (2)

The combined technique

ACTIVE COMPARATOR

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.

Procedure: Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).

CO2 laser vaporization only

ACTIVE COMPARATOR

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.

Procedure: Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).

Interventions

Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies). PROCEDURE

cf. different arms

CO2 laser vaporization only; The combined technique

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• GZA Ziekenhuizen Campus Sint-Augustinus: collaborator
• Centre Hospitalier Régional de la Citadelle: collaborator
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: collaborator

Study Sites (4)

GZA Sint-Augustinus

Antwerp, 2610, Belgium

RECRUITING

Cliniques universitaires Saint-LUC (UCL)

Brussels, Belgium

RECRUITING

UZLeuven

Leuven, 3000, Belgium

RECRUITING

CHR La Citadelle

Liège, 4000, Belgium

RECRUITING

Related Publications (1)

• Bafort C, Lie Fong S, Fieuws S, Geysenbergh B, Nisolle M, Squifflet JL, Tebache L, Wyns C, Meuleman C, Tomassetti C. Conservative endometrioma surgery: The combined technique versus CO2-laser vaporization only (BLAST: Belgium LAser STudy): Clinical protocol for a multicenter randomized controlled trial. PLoS One. 2025 Mar 6;20(3):e0315709. doi: 10.1371/journal.pone.0315709. eCollection 2025.

  PMID: 40048474 DERIVED

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Carla Tomassetti, MD, PhD

  Leuven University Fertility Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla Tomassetti, MD, PhD

CONTACT

+3216340825; carla.tomassetti@uzleuven.be

Celine Bafort, MD

CONTACT

+3216340088; celine.bafort@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 5, 2019
• Study Start: October 24, 2019
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4)