NCT02669628

Brief Summary

The purpose of this multicenter study is to evaluate the ovarian reserve after alcohol sclerotherapy of endometriomas versus conventional surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

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

January 23, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

1.9 years

First QC Date

January 23, 2016

Last Update Submit

February 21, 2018

Conditions

Endometriomas

Outcome Measures

Primary Outcomes (1)

  • AMH Test

    the value of AMH after both procedures in ng/mL

    6 months

Secondary Outcomes (4)

  • antral follicles count

    6 months

  • tumoral markers: epididimal human protein 4 (HE-4) and CA125

    6 months

  • complications

    1 day

  • costs

    1 day

Study Arms (2)

Surgical technique

Laparoscopic ovarian cystectomy

Procedure: Surgical technique

Alcohol sclerotherapy

US-aspiration and alcohol sclerosis

Procedure: Alcohol sclerotherapy

Interventions

Surgical techniquePROCEDURE

Laparoscopic surgery

Surgical technique
Alcohol sclerotherapyPROCEDURE

US-guided sclerotherapy

Alcohol sclerotherapy

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with ultrasound suspicion of ovarian endometrioma (4-10 cm)

You may qualify if:

  • Women
  • Age ≥18 and \<40 years
  • Unilocular endometrioma according ultrasounds
  • Endometrioma size: 35-100 mm during \> 3 months from diagnosis
  • CA125 \<200 IU/mL and HE4 \< 70,
  • AMH previous surgery between 1.2-4 ng/mL

You may not qualify if:

  • Previous ovarian surgery or gynecological cancer
  • Severe extraovarian endometriosis
  • Dermoid or high risk of malignancy cysts
  • Hormonal treatment 3 months before
  • Pregnancy
  • Mental disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

Related Publications (12)

  • 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

  • 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: 22723324BACKGROUND

  • 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: 22019621BACKGROUND

  • 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

  • Messalli EM, Cobellis G, Pecori E, Pierno G, Scaffa C, Stradella L, Cobellis L. Alcohol sclerosis of endometriomas after ultrasound-guided aspiration. Minerva Ginecol. 2003 Aug;55(4):359-62.

    PMID: 14581861BACKGROUND

  • 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

  • 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: 19573300BACKGROUND

  • 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: 25739052BACKGROUND

  • 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: 22975114BACKGROUND

  • Koike T, Minakami H, Motoyama M, Ogawa S, Fujiwara H, Sato I. Reproductive performance after ultrasound-guided transvaginal ethanol sclerotherapy for ovarian endometriotic cysts. Eur J Obstet Gynecol Reprod Biol. 2002 Oct 10;105(1):39. doi: 10.1016/s0301-2115(02)00144-6.

    PMID: 12270563BACKGROUND

MeSH Terms

Conditions

Endometriosis

Interventions

Wound Closure TechniquesEthanol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeAlcoholsOrganic Chemicals

Study Officials

  • Amparo Garcia-Tejedor, MDPhD

    Hospital de Bellvitge. IDIBELL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 23, 2016

First Posted

February 1, 2016

Study Start

February 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

February 23, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

The individual participant data should be available 6 months after the procedure

Locations

ES(1)