Endometriosis OvaryBLASTNCT04151433
Conservative Endometrioma Surgery
A study testing Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies). in people with Endometriosis Ovary and Endometrioma, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometriosis Ovary, Endometrioma
- What is being tested?
- Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 4 sitesBelgium
- Study dates
- 24 Oct 2019to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Suspected malignancy
- Contralateral endometrioma of >2 cm
- AMH <0.7 preoperatively
- Pregnancy
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium4 sites, 4 recruiting
- Recruiting
GZA Sint-Augustinus
Antwerp, 2610
Brecht Geysenbergh, MD
Brecht Geysenbergh, MD
- Recruiting
Cliniques universitaires Saint-LUC (UCL)
Brussels
Laurence Beausaert
Jean-Luc Squifflet, MD, PhD
- Recruiting
UZLeuven
Leuven, 3000
Celine Bafort, MD, celine.bafort@uzleuven.be
Carla Tomassetti, MD, PhD
- Recruiting
CHR La Citadelle
Liège, 4000
Marie Timmermans, Msc
Michelle Nisolle, MD, Phd
About this study
Official title: BLAST: a Randomized Controlled Trial on Conservative Endometrioma Surgery Using the CO2 Laser: the Combined Technique Versus CO2 Laser Vaporization Only
To study which surgical technique offers better results in treating endometriomas in terms of ovarian reserve preservation.
The 2 conservatives techniques used are:
- The combined technique
- CO2 laser vaporization only
Ovarian reserve will be assessed by consecutive measurements of AMH serum levels before and after surgery.
- Conditions
- Endometriosis Ovary, Endometrioma
- Being tested
- Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).Procedure or surgery
cf. different arms
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start24 Oct 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endometriosis OvaryStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- GZA Ziekenhuizen Campus Sint-Augustinus, Centre Hospitalier Régional de la Citadelle, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Responsible party
- Sponsor
- Investigators
- Carla Tomassetti, MD, PhD, Principal investigator, Leuven University Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151433
- Sponsor's protocol ID
- S62899
- Acronym
- BLAST
- Status last verified
- Dec 2024
- First submitted
- 31 Oct 2019
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40048474
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLAST: a Randomized Controlled Trial on Conservative Endometrioma Surgery Using the CO2 Laser: the Combined Technique Versus CO2 Laser Vaporization Only
- ClinicalTrials.gov ID
- NCT04151433
- Acronym / sponsor ID
- BLAST / S62899
- Conditions
- Endometriosis Ovary, Endometrioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- GZA Ziekenhuizen Campus Sint-Augustinus, Centre Hospitalier Régional de la Citadelle, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study which surgical technique offers better results in treating endometriomas in terms of ovarian reserve preservation.
The 2 conservatives techniques used are:
- The combined technique
- CO2 laser vaporization only
Ovarian reserve will be assessed by consecutive measurements of AMH serum levels before and after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The combined technique | Active comparator | Procedure: Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).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. |
| CO2 laser vaporization only | Active comparator | 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 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).cf. different arms | Procedure or surgery | CO2 laser vaporization only, The combined technique |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Derived from this study: PubMed 40048474Bafort 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carla Tomassetti, MD, PhD principal investigator
Leuven University Fertility Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies). in people with Endometriosis Ovary and Endometrioma, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carla Tomassetti, MD, PhD (+3216340825, carla.tomassetti@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AMH levels 3 months postoperatively (time frame: 3 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04151433, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.