The purpose of this multicenter study is to compare the ovarian reserve after alcohol sclerosis of the endometriomas against conventional surgery (AMH, follicle stimulating hormone (FSH) and antral follicles count) as well as the complications and costs between the 2 procedures.
Clinical Trial Phase III, Multicenter, National, open, parallel-group assignment 1: 1, stratified by age, previous oophorectomy and uni- or bilateral ovarian involvement. Patients with suspected ovarian endometrioma by ultrasound will be randomized into 2 groups: (a) Study Group: echoguided aspiration plus sclerosis with alcohol; (B) Control group: Laparoscopic Cystectomy. Pre-treatment, and 6 months after treatment, AMH values will be determined. Complications, recurrences and costs from each treatment will be collected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
158
Laparoscopic ovarian cystectomy
US-aspiration and alcohol sclerosis
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Change from Baseline AMH Test
the value of AMH in ng/mL
Time frame: prior and 6 months after both procedures
Change from Baseline antral follicles count
US antral follicles count
Time frame: prior and 6 months after both procedures
Complications
number of participants with complications
Time frame: 1 month after the procedure
Costs
costs (euros) of the procedure plus cost of their complications
Time frame: 1 month after the procedure
Change from Baseline Pain
Visual Analog Score for pain (ranged 1-10). Patients pain evaluation fron 1 no pain to 10 maximum pain considered
Time frame: prior and 6 months after both procedures
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