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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05801523
Other study ID # AMHstudy
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date July 1, 2025

Study information

Verified date May 2024
Source Institute for the Care of Mother and Child, Prague, Czech Republic
Contact Katarína Ivánková
Phone +420 296511200
Email katarina.ivankova@upmd.eu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


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Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
laparoscopic ethanol sclerotherapy
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
laparoscopic cystectomy of endometrioma
cystectomy of endometrioma - removal of endometrioma from ovary surgically

Locations

Country Name City State
Czechia Institute for mother and child care Prague

Sponsors (2)

Lead Sponsor Collaborator
Institute for the Care of Mother and Child, Prague, Czech Republic University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (12)

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Outcome

Type Measure Description Time frame Safety issue
Primary AMH dynamics Measuring AMH level in blood Measuring change in AMH levels immediately before surgery and than at 6 and 12 months after surgery
Primary 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
Primary complications recording all complications related to surgery, classified according Clavien Dindo 0-12 months
Secondary 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
Secondary pregnancy rate pregnancy rate among study patients 0-24 months after surgery
Secondary deliveries number of deliveries after surgery 24 months
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