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

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

Conditions
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Endometrioma, Endometriosis

Intervention / Treatment
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* Procedure: laparoscopic ethanol sclerotherapy
* Procedure: laparoscopic cystectomy of endometrioma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: laparoscopic ethanol sclerotherapy<br> | Procedure: laparoscopic ethanol sclerotherapy<br>* 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<br>|
| Active Comparator: laparoscopic cystectomy<br> | Procedure: laparoscopic cystectomy of endometrioma<br>* cystectomy of endometrioma - removal of endometrioma from ovary surgically<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AMH dynamics | Measuring AMH level in blood | 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 | 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 | 0-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asissted reproduction methods succes rate | if patient undergoes assisted reproduction techniques and gets pregnant we check what methodes were used | 0-24 months after surgery | 
| pregnancy rate | pregnancy rate among study patients | 0-24 months after surgery | 
| deliveries | number of deliveries after surgery | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic, sclerotherapy, endometrioma