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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05801523
• Other study ID #: AMHstudy
• Status: Recruiting
• Phase: N/A
• 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
• 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: July 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis

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)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

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

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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

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