Laparoscopic Therapy of Endometrioma: Sclerotherapy vs Cystectomy in Patients With Unfinished Reproductive Plans

Institute for the Care of Mother and Child, Prague, Czech Republic

Status

Enrolling

Conditions

Endometriosis

Endometrioma

Treatments

Procedure: laparoscopic ethanol sclerotherapy

Procedure: laparoscopic cystectomy of endometrioma

Study type

Interventional

Funder types

Other

Identifiers

NCT05801523

AMHstudy

Details and patient eligibility

About

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

Full description

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

Enrollment

160 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

IOTA benign endometrioma
bilateral or unilateral endometrioma measuring 30 or more milimeters
patients with unfinished reproductive plans

Exclusion criteria

bilateral recurrence of endometrioma
recurrent endometrioma if the other ovary is not present or patient had cystectomy on the other ovary
suspision for ovarian malignancy
signs of inflammatory pelvic disease
disagreement with participation in the study