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ClinicalTrials.gov ID

NCT04151433

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

92Estimated

Last Update Posted

Dec 10, 2024Actual

Start Date

Oct 24, 2019Actual

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2026Estimated

Official Title

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

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.

• Endometriosis Ovary
• Endometrioma

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

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Crossover Assignment

Masking

None (Open Label)

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Collaborators

GZA Ziekenhuizen Campus Sint-AugustinusOTHER

Centre Hospitalier Régional de la CitadelleOTHER

Cliniques universitaires Saint-Luc- Université Catholique de LouvainOTHER

celine.bafort@uzleuven.be