The aim of this prospective randomized study is to compare laparoscopic sclerotherapy to cystectomy in following: AMH dynamics, endometrioma recurrence, complications, pregnancy rate, assisted reproduction methods success rate, live birth rate
Only patients who sign informed consent will be included. Only patients wishing for future pregnancy will be involved in the study. Expected number of enrolled subjects is 160 ( 80 in each arm) Patients with endometrioma and planned surgery to remove it will be randomized either to laparoscopic sclerotherapy with 96% ethanol or cystectomy. First AMH sample will be taken day before surgery. If other endometriosis lesions (deep or superficial) are present, they may be also resected during this surgery. Ethanol sclerotherapy description: classical laparoscopic approach - small (max1cm) fenestration of endometrioma - aspiration of endometrioma contents- foley catheter insertion- ballon inflation inside of the cyst- instillation with 96% ethanol which is left in the cyst for 10min- aspiration of ethanol and flushing with saline. Cystectomy: classical laparoscopic approach- large fenestration of endometrioma - aspiration of endometrioma contents- indentification of ovary/ endometrioma tissue and plane between the ovarian capsule and cyst wall is developed using a mix of blunt and sharp dissection - if bleeding is present it is stopped by cautious bipolar coagulation visit 1 - surgery time (AMH day before surgery, age, BMI, endometriosis extent, gravidity/ parity, endometriosis residue after surgery, pain levels) visit 2- 3 months after surgery : Ultrasound, complications, pregnancy, asissted reproduction, pain levels visit 3+4 - 6/12months after surgery: AMH, Ultrasound, complications, pregnancy, asissted reproduction, pain levels visit 5- 24 months after surgery: Ultrasound, complications, pregnancy, asissted reproduction, pain levels
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
160
ethanol (96%) sclerapy of endometrioma - endometrioma is filled with ethanol via foley catether, left for 10 min and than aspirated, endometrioma is washed with saline
cystectomy of endometrioma - removal of endometrioma from ovary surgically
Institute for mother and child care
Prague, Czechia
RECRUITINGAMH dynamics
Measuring AMH level in blood
Time frame: Measuring change in AMH levels immediately before surgery and than at 6 and 12 months after surgery
endometrioma recurrence
recurrence described as endometrioma measuring 20 or more milimeters on ultrasound
Time frame: Measuring change of endometrioma size (in case of recurrence) at 3, 6, 12 and 24 months after surgery
complications
recording all complications related to surgery, classified according Clavien Dindo
Time frame: 0-12 months
Asissted reproduction methods succes rate
if patient undergoes assisted reproduction techniques and gets pregnant we check what methodes were used
Time frame: 0-24 months after surgery
pregnancy rate
pregnancy rate among study patients
Time frame: 0-24 months after surgery
deliveries
number of deliveries after surgery
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.