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NCT Number: NCT04151433

Conservative Endometrioma Surgery

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.

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Key information

Conditions

Endometriosis Ovary Endometrioma Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

GZA Sint-Augustinus, Antwerp, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

cf. different arms

Primary outcomes

AMH levels 3 months postoperatively

Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Carla Tomassetti, MD, PhD

CONTACT

[email protected]

+3216340825

Celine Bafort, MD

CONTACT

[email protected]

+3216340088

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

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

Registry information

Official study title

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

Acronym: BLAST

Important dates

Study start: 2019
Primary completion: 2024
Study completion: 2026
First posted: Nov 5, 2019
Registry last updated: Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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