NCT03571776

Brief Summary

The purpose of this multicenter study is to compare the ovarian reserve after alcohol sclerosis of the endometriomas against conventional surgery (AMH, follicle stimulating hormone (FSH) and antral follicles count) as well as the complications and costs between the 2 procedures.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

June 5, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 28, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

4.6 years

First QC Date

May 31, 2018

Last Update Submit

February 28, 2023

Conditions

EndometriomaFertility Disorders

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline AMH Test

    the value of AMH in ng/mL

    prior and 6 months after both procedures

Secondary Outcomes (4)

  • Change from Baseline antral follicles count

    prior and 6 months after both procedures

  • Complications

    1 month after the procedure

  • Costs

    1 month after the procedure

  • Change from Baseline Pain

    prior and 6 months after both procedures

Study Arms (2)

Surgery

ACTIVE COMPARATOR

Laparoscopic ovarian cystectomy

Procedure: Surgery

Sclerotherapy

ACTIVE COMPARATOR

US-aspiration and alcohol sclerosis

Procedure: Sclerotherapy

Interventions

SurgeryPROCEDURE

Laparoscopic ovarian cystectomy

Surgery
SclerotherapyPROCEDURE

US-aspiration and alcohol sclerosis

Sclerotherapy

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Uni- or bilocular endometrioma according ultrasounds
  • Endometrioma size: 30-100 mm when symptoms were present and 50-100 mm if asymptomatics
  • \> 3 months from diagnosis
  • Ca125 \<200 IU/mL and human epididymis protein 4 (HE4) \< 70,

You may not qualify if:

  • Previous gynecological cancer
  • Symptomatic severe extraovarian endometriosis
  • Dermoid or high risk of malignancy cysts
  • Pregnancy
  • Mental disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (11)

  • Coccia ME, Rizzello F, Cammilli F, Bracco GL, Scarselli G. Endometriosis and infertility Surgery and ART: An integrated approach for successful management. Eur J Obstet Gynecol Reprod Biol. 2008 May;138(1):54-9. doi: 10.1016/j.ejogrb.2007.11.010. Epub 2008 Feb 20.

    PMID: 18243485BACKGROUND

  • Muzii L, Bianchi A, Croce C, Manci N, Panici PB. Laparoscopic excision of ovarian cysts: is the stripping technique a tissue-sparing procedure? Fertil Steril. 2002 Mar;77(3):609-14. doi: 10.1016/s0015-0282(01)03203-4.

    PMID: 11872220BACKGROUND

  • Akamatsu N, Hirai T, Masaoka H, Sekiba K, Fujita T. [Ultrasonically guided puncture of endometrial cysts--aspiration of contents and infusion of ethanol]. Nihon Sanka Fujinka Gakkai Zasshi. 1988 Feb;40(2):187-91. Japanese.

    PMID: 3283269BACKGROUND

  • Noma J, Yoshida N. Efficacy of ethanol sclerotherapy for ovarian endometriomas. Int J Gynaecol Obstet. 2001 Jan;72(1):35-9. doi: 10.1016/s0020-7292(00)00307-6.

    PMID: 11146075BACKGROUND

  • Kafali H, Eser A, Duvan CI, Keskin E, Onaran YA. Recurrence of ovarian cyst after sclerotherapy. Minerva Ginecol. 2011 Feb;63(1):19-24.

    PMID: 21311417BACKGROUND

  • Raffi F, Metwally M, Amer S. The impact of excision of ovarian endometrioma on ovarian reserve: a systematic review and meta-analysis. J Clin Endocrinol Metab. 2012 Sep;97(9):3146-54. doi: 10.1210/jc.2012-1558. Epub 2012 Jun 20.

    PMID: 22723324RESULT

  • Biacchiardi CP, Piane LD, Camanni M, Deltetto F, Delpiano EM, Marchino GL, Gennarelli G, Revelli A. Laparoscopic stripping of endometriomas negatively affects ovarian follicular reserve even if performed by experienced surgeons. Reprod Biomed Online. 2011 Dec;23(6):740-6. doi: 10.1016/j.rbmo.2011.07.014. Epub 2011 Jul 27.

    PMID: 22019621RESULT

  • Yazbeck C, Madelenat P, Ayel JP, Jacquesson L, Bontoux LM, Solal P, Hazout A. Ethanol sclerotherapy: a treatment option for ovarian endometriomas before ovarian stimulation. Reprod Biomed Online. 2009 Jul;19(1):121-5. doi: 10.1016/s1472-6483(10)60055-7.

    PMID: 19573300RESULT

  • Garcia-Tejedor A, Castellarnau M, Ponce J, Fernandez ME, Burdio F. Ethanol sclerotherapy of ovarian endometrioma: a safe and effective minimal invasive procedure. Preliminary results. Eur J Obstet Gynecol Reprod Biol. 2015 Apr;187:25-9. doi: 10.1016/j.ejogrb.2015.02.004. Epub 2015 Feb 16.

    PMID: 25739052RESULT

  • Somigliana E, Berlanda N, Benaglia L, Vigano P, Vercellini P, Fedele L. Surgical excision of endometriomas and ovarian reserve: a systematic review on serum antimullerian hormone level modifications. Fertil Steril. 2012 Dec;98(6):1531-8. doi: 10.1016/j.fertnstert.2012.08.009. Epub 2012 Sep 10.

    PMID: 22975114RESULT

  • Garcia-Tejedor A, Guevara-Peralta R, Martinez-Garcia JM, Corbalan S, Aguero M, Gomez-Romero M, Cararach M, Castellarnau M, Rodriguez M, Lou-Mercade AC, Costa L, Rodriguez MJ, Huguet E, Carreras M, Castel-Segui AB, Font-Roig M, Royo S, Sarasa N, Candas B, Perez-Carton S, Ortega C, Pla MJ, Ponce J. Ultrasound-guided ethanol sclerotherapy versus laparoscopic surgery for endometriomas: a randomized clinical trial in a real-world setting. Arch Gynecol Obstet. 2025 Dec;312(6):2199-2210. doi: 10.1007/s00404-025-08205-1. Epub 2025 Nov 4.

    PMID: 41186685DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

Surgical Procedures, OperativeSclerotherapy

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Amparo Garcia-Tejedor, MDPhD

    Hospital de Bellvitge. IDIBELL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multicenter, National, assignment 1: 1, stratified by age, previous oophorectomy and uni- or bilateral ovarian involvement.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 31, 2018

First Posted

June 28, 2018

Study Start

June 5, 2018

Primary Completion

January 15, 2023

Study Completion

January 15, 2023

Last Updated

March 2, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)