Actively Recruiting
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-12-10
92
Participants Needed
4
Research Sites
104 weeks
Total Duration
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
G
GZA Ziekenhuizen Campus Sint-Augustinus
Collaborating Sponsor
Researchers are evaluating two surgical techniques for treating endometriomas to determine which better preserves ovarian reserve. The study focuses on women with endometriotic cysts who experience infertility or pain. The trial compares the combined technique and CO2 laser vaporization only, assessing ovarian reserve through Anti-Müllerian Hormone (AMH) serum levels before and after surgery. Two surgical methods are studied: the combined technique involves stripping about 80% of the cyst wall followed by ablation of the remaining 20%, while the CO2 laser vaporization method uses CO2 laser to ablate the entire inner cyst wall after draining and inspecting the cyst. The laser settings are carefully controlled to preserve healthy tissue beneath the cyst surface. Participants will have their AMH levels measured three months after surgery to assess ovarian reserve. The study includes women aged 18 to 40 with specific cyst sizes and requires contraception use before surgery. Researchers monitor outcomes through hormone measurements and clinical follow-up to evaluate the effect of each surgical approach on ovarian function.
CONDITIONS
Conservative Endometrioma Surgery
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo conservative laparoscopic surgery for endometriomas using one of two accepted surgical techniques.
1 surgical visit and immediate post-operative care
Duration - 3 months postoperatively
Participants are monitored after surgery to assess recovery and measure outcomes such as AMH levels.
1 follow-up visit at 3 months post-surgery
Total: 4 locations
1
GZA Sint-Augustinus
Antwerp, Belgium, 2610
Actively Recruiting
2
Cliniques universitaires Saint-LUC (UCL)
Brussels, Belgium
Actively Recruiting
3
UZLeuven
Leuven, Belgium, 3000
Actively Recruiting
4
CHR La Citadelle
Liège, Belgium, 4000
Actively Recruiting
C
Carla Tomassetti, MD, PhD
C
Celine Bafort, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Celine Bafort, Sharon Lie Fong, Steffen Fieuws...
https://pubmed.ncbi.nlm.nih.gov/40048474