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

Primary Purpose

Endometrioma, Endometriosis

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
laparoscopic ethanol sclerotherapy
laparoscopic cystectomy of endometrioma
Sponsored by
Institute for the Care of Mother and Child, Prague, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrioma focused on measuring laparoscopic, sclerotherapy, endometrioma

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Institute for mother and child careRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

laparoscopic ethanol sclerotherapy

laparoscopic cystectomy

Arm Description

Outcomes

Primary Outcome Measures

AMH dynamics
Measuring AMH level in blood
endometrioma recurrence
recurrence described as endometrioma measuring 20 or more milimeters on ultrasound
complications
recording all complications related to surgery, classified according Clavien Dindo

Secondary Outcome Measures

Asissted reproduction methods succes rate
if patient undergoes assisted reproduction techniques and gets pregnant we check what methodes were used
pregnancy rate
pregnancy rate among study patients
deliveries
number of deliveries after surgery

Full Information

First Posted
March 23, 2023
Last Updated
April 5, 2023
Sponsor
Institute for the Care of Mother and Child, Prague, Czech Republic
Collaborators
University Hospital Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT05801523
Brief Title
Laparoscopic Therapy of Endometrioma: Sclerotherapy vs Cystectomy in Patients With Unfinished Reproductive Plans
Official Title
Laparoscopic Therapy of Endometrioma: Sclerotherapy vs Cystectomy in Patients With Unfinished Reproductive Plans
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute for the Care of Mother and Child, Prague, Czech Republic
Collaborators
University Hospital Ostrava

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrioma, Endometriosis
Keywords
laparoscopic, sclerotherapy, endometrioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laparoscopic ethanol sclerotherapy
Arm Type
Active Comparator
Arm Title
laparoscopic cystectomy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
laparoscopic ethanol sclerotherapy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
laparoscopic cystectomy of endometrioma
Intervention Description
cystectomy of endometrioma - removal of endometrioma from ovary surgically
Primary Outcome Measure Information:
Title
AMH dynamics
Description
Measuring AMH level in blood
Time Frame
Measuring change in AMH levels immediately before surgery and than at 6 and 12 months after surgery
Title
endometrioma recurrence
Description
recurrence described as endometrioma measuring 20 or more milimeters on ultrasound
Time Frame
Measuring change of endometrioma size (in case of recurrence) at 3, 6, 12 and 24 months after surgery
Title
complications
Description
recording all complications related to surgery, classified according Clavien Dindo
Time Frame
0-12 months
Secondary Outcome Measure Information:
Title
Asissted reproduction methods succes rate
Description
if patient undergoes assisted reproduction techniques and gets pregnant we check what methodes were used
Time Frame
0-24 months after surgery
Title
pregnancy rate
Description
pregnancy rate among study patients
Time Frame
0-24 months after surgery
Title
deliveries
Description
number of deliveries after surgery
Time Frame
24 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katarína Ivánková
Phone
+420 296511200
Email
katarina.ivankova@upmd.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katarína Ivánková, MUDr.
Organizational Affiliation
Institute for the Care of Mother and Child, Prague, Czech Republic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for mother and child care
City
Prague
ZIP/Postal Code
147 00
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katarína Ivánková, MUDr.
Email
katarina.ivankova@upmd.eu
First Name & Middle Initial & Last Name & Degree
Katarína Ivánková, MUDr.
First Name & Middle Initial & Last Name & Degree
Zuzana Marvanova, MUDr.
First Name & Middle Initial & Last Name & Degree
Lucie Hájková Hympánová, MUDr.

12. IPD Sharing Statement

Citations:
PubMed Identifier
29420391
Citation
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Results Reference
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PubMed Identifier
12858105
Citation
Busacca M, Vignali M. Ovarian endometriosis: from pathogenesis to surgical treatment. Curr Opin Obstet Gynecol. 2003 Aug;15(4):321-6. doi: 10.1097/01.gco.0000084247.09900.4f.
Results Reference
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PubMed Identifier
28579409
Citation
Cohen A, Almog B, Tulandi T. Sclerotherapy in the management of ovarian endometrioma: systematic review and meta-analysis. Fertil Steril. 2017 Jul;108(1):117-124.e5. doi: 10.1016/j.fertnstert.2017.05.015. Epub 2017 Jun 1.
Results Reference
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PubMed Identifier
29935810
Citation
Kasapoglu I, Ata B, Uyaniklar O, Seyhan A, Orhan A, Yildiz Oguz S, Uncu G. Endometrioma-related reduction in ovarian reserve (ERROR): a prospective longitudinal study. Fertil Steril. 2018 Jul 1;110(1):122-127. doi: 10.1016/j.fertnstert.2018.03.015. Epub 2018 Jun 20.
Results Reference
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PubMed Identifier
36228863
Citation
Crestani A, Merlot B, Dennis T, Chanavaz-Lacheray I, Roman H. Impact of Laparoscopic Sclerotherapy for Ovarian Endometriomas on Ovarian Reserve. J Minim Invasive Gynecol. 2023 Jan;30(1):32-38. doi: 10.1016/j.jmig.2022.10.001. Epub 2022 Oct 10.
Results Reference
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PubMed Identifier
32380241
Citation
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Results Reference
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PubMed Identifier
19502358
Citation
Benaglia L, Somigliana E, Vercellini P, Abbiati A, Ragni G, Fedele L. Endometriotic ovarian cysts negatively affect the rate of spontaneous ovulation. Hum Reprod. 2009 Sep;24(9):2183-6. doi: 10.1093/humrep/dep202. Epub 2009 Jun 5.
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20083485
Citation
Benaglia L, Somigliana E, Vighi V, Ragni G, Vercellini P, Fedele L. Rate of severe ovarian damage following surgery for endometriomas. Hum Reprod. 2010 Mar;25(3):678-82. doi: 10.1093/humrep/dep464. Epub 2010 Jan 17.
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Citation
Jee BC. Efficacy of ablation and sclerotherapy for the management of ovarian endometrioma: A narrative review. Clin Exp Reprod Med. 2022 Jun;49(2):76-86. doi: 10.5653/cerm.2021.05183. Epub 2022 May 4.
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PubMed Identifier
26492167
Citation
Giampaolino P, Bifulco G, Di Spiezio Sardo A, Mercorio A, Bruzzese D, Di Carlo C. Endometrioma size is a relevant factor in selection of the most appropriate surgical technique: a prospective randomized preliminary study. Eur J Obstet Gynecol Reprod Biol. 2015 Dec;195:88-93. doi: 10.1016/j.ejogrb.2015.09.046. Epub 2015 Oct 24.
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Citation
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Results Reference
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Laparoscopic Therapy of Endometrioma: Sclerotherapy vs Cystectomy in Patients With Unfinished Reproductive Plans

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