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

May 6, 2024 updated by: Katarina Ivankova, Institute for the Care of Mother and Child, Prague, Czech Republic
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
      • Prague, Czechia, 147 00
        • Recruiting
        • Institute for Mother and Child Care
        • Contact:
        • Principal Investigator:
          • Katarína Ivánková, MUDr.
        • Sub-Investigator:
          • Zuzana Marvanova, MUDr.
        • Sub-Investigator:
          • Lucie Hájková Hympánová, MUDr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AMH dynamics
Time Frame: Measuring change in AMH levels immediately before surgery and than at 6 and 12 months after surgery
Measuring AMH level in blood
Measuring change in AMH levels immediately before surgery and than at 6 and 12 months after surgery
endometrioma recurrence
Time Frame: Measuring change of endometrioma size (in case of recurrence) at 3, 6, 12 and 24 months after surgery
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
Time Frame: 0-12 months
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
Time Frame: 0-24 months after surgery
if patient undergoes assisted reproduction techniques and gets pregnant we check what methodes were used
0-24 months after surgery
pregnancy rate
Time Frame: 0-24 months after surgery
pregnancy rate among study patients
0-24 months after surgery
deliveries
Time Frame: 24 months
number of deliveries after surgery
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

University Hospital Ostrava

Investigators

  • Principal Investigator: Katarína Ivánková, MUDr., Institute for the Care of Mother and Child, Prague, Czech Republic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

April 5, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMHstudy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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