Conservative Endometrioma Surgery | NCT04151433

NCT04151433

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Name	Class
GZA Ziekenhuizen Campus Sint-Augustinus	OTHER
Centre Hospitalier Régional de la Citadelle	OTHER
Cliniques universitaires Saint-Luc- Université Catholique de Louvain	OTHER

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).	Procedure	cf. different arms

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Carla Tomassetti, MD, PhD	Contact	+3216340825		carla.tomassetti@uzleuven.be
Celine Bafort, MD	Contact	+3216340088		celine.bafort@uzleuven.be

Name	Affiliation	Role
Carla Tomassetti, MD, PhD	Leuven University Fertility Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
GZA Sint-Augustinus	Recruiting	Antwerp		2610	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40048474	Derived	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.

IPD Sharing Statement Module

Condition Browse Module

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases