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

Last updated: May 6, 2024
Sponsor: Institute for the Care of Mother and Child, Prague, Czech Republic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Endometriosis

Treatment

laparoscopic cystectomy of endometrioma

laparoscopic ethanol sclerotherapy

Clinical Study ID

NCT05801523
AMHstudy
  • Ages 18-40
  • Female
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: laparoscopic cystectomy of endometrioma
Phase:
Study Start date:
February 01, 2023
Estimated Completion Date:
July 01, 2025

Study 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

Connect with a study center

  • Institute for mother and child care

    Prague, 147 00
    Czechia

    Active - Recruiting

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