Conservative Endometrioma Surgery

Endometrioma Clinical Trial

— BLAST  

Official title:

BLAST: a Randomized Controlled Trial on Conservative Endometrioma Surgery Using the CO2 Laser: the Combined Technique Versus CO2 Laser Vaporization Only

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04151433
• Other study ID #: S62899
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2019
• Est. completion date: December 2026

Study information

• Verified date: November 2023
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: Carla Tomassetti, MD, PhD
• Phone: +3216340825
• Email: carla.tomassetti[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Population: patients planned for laparoscopic CO2 laser surgery for endometriotic cysts.

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

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis
• Endometriosis Ovary

Intervention

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

Locations

Country	Name	City	State
Belgium	GZA Sint-Augustinus	Antwerp
Belgium	Cliniques universitaires Saint-LUC (UCL)	Brussel
Belgium	UZLeuven	Leuven
Belgium	CHR La Citadelle	Liège

Sponsors (4)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven	Centre Hospitalier Régional de la Citadelle, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, GZA Ziekenhuizen Campus Sint-Augustinus

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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