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

NCT05801523 | Recruiting

• 1 other identifier: AMHstudy
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Endometrioma; Endometriosis

Keywords

laparoscopic; sclerotherapy; endometrioma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Asissted reproduction methods succes rate

  0-24 months after surgery

• pregnancy rate

  0-24 months after surgery

• deliveries

  24 months

Study Arms (2)

laparoscopic ethanol sclerotherapy

ACTIVE COMPARATOR

Procedure: laparoscopic ethanol sclerotherapy

laparoscopic cystectomy

ACTIVE COMPARATOR

Procedure: laparoscopic cystectomy of endometrioma

Interventions

laparoscopic ethanol sclerotherapy PROCEDURE

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 ethanol sclerotherapy

laparoscopic cystectomy of endometrioma PROCEDURE

cystectomy of endometrioma - removal of endometrioma from ovary surgically

laparoscopic cystectomy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute for the Care of Mother and Child, Prague, Czech Republic: lead
• University Hospital Ostrava: collaborator

Study Sites (1)

Institute for mother and child care

Prague, 147 00, Czechia

RECRUITING

Related Publications (12)

• Falcone T, Flyckt R. Clinical Management of Endometriosis. Obstet Gynecol. 2018 Mar;131(3):557-571. doi: 10.1097/AOG.0000000000002469.

  PMID: 29420391 BACKGROUND

• 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.

  PMID: 12858105 BACKGROUND

• 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.

  PMID: 28579409 BACKGROUND

• 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.

  PMID: 29935810 BACKGROUND

• 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.

  PMID: 36228863 BACKGROUND

• De Cicco Nardone A, Carfagna P, De Cicco Nardone C, Scambia G, Marana R, De Cicco Nardone F. Laparoscopic Ethanol Sclerotherapy for Ovarian Endometriomas: Preliminary Results. J Minim Invasive Gynecol. 2020 Sep-Oct;27(6):1331-1336. doi: 10.1016/j.jmig.2019.09.792. Epub 2020 May 5.

  PMID: 32380241 BACKGROUND

• 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.

  PMID: 19502358 BACKGROUND

• 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.

  PMID: 20083485 BACKGROUND

• 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.

  PMID: 35698769 BACKGROUND

• 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.

  PMID: 26492167 BACKGROUND

• Garcia-Tejedor A, Martinez-Garcia JM, Candas B, Suarez E, Manalich L, Gomez M, Merino E, Castellarnau M, Regueiro P, Carreras M, Martinez-Franco E, Carrarrach M, Subirats N, Barbera J, Gonzalez S, Climent M, Fernandez-Montoli E, Ponce J. Ethanol Sclerotherapy versus Laparoscopic Surgery for Endometrioma Treatment: A Prospective, Multicenter, Cohort Pilot Study. J Minim Invasive Gynecol. 2020 Jul-Aug;27(5):1133-1140. doi: 10.1016/j.jmig.2019.08.036. Epub 2020 Apr 7.

  PMID: 32272240 BACKGROUND

• Aflatoonian A, Tabibnejad N. Aspiration versus retention ultrasound-guided ethanol sclerotherapy for treating endometrioma: A retrospective cross-sectional study. Int J Reprod Biomed. 2020 Nov 22;18(11):935-942. doi: 10.18502/ijrm.v13i11.7960. eCollection 2020 Nov.

  PMID: 33349801 BACKGROUND

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Katarína Ivánková, MUDr.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katarína Ivánková

CONTACT

+420 296511200; katarina.ivankova@upmd.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor at Endometriosis centre, Institute for the mother and child care

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 6, 2023
• Study Start: February 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

CZ (1)