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Recruiting NCT04151433

Conservative Endometrioma Surgery

No phase Interventional Endometriosis Ovary Endometrioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies)..
Who it may be relevant to
Registry conditions: Endometriosis Ovary, Endometrioma. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • AMH levels 3 months postoperatively [Time frame: 3 months postoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 4 centers
  • GZA Sint-Augustinus — Antwerp
  • Cliniques universitaires Saint-LUC (UCL) — Brussels
  • UZLeuven — Leuven
  • CHR La Citadelle — Liège

Publications

  • 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

Identifiers

NCT: NCT04151433 · S62899

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗