NCT02472873

Brief Summary

The purpose of this study is to evaluate the efficacy of aspiration and sclerotherapy during laparoscopy using 95% ethanol for the treatment of endometriomas, compared to the standard cystectomy treatment - a prospective case control study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 16, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

June 16, 2015

Status Verified

June 1, 2015

Enrollment Period

4 years

First QC Date

June 7, 2015

Last Update Submit

June 15, 2015

Conditions

EndometriomaEndometriosis

Keywords

endometriomaendometriosissclerotherapyethanolaspirationlaparoscopy

Outcome Measures

Primary Outcomes (1)

  • endometrioma recurrence rate

    Ultrasound examination that demonstrate the presence/lack of ovarian cyst with sonographic features of endometrioma in the ovary where the sclerotherapy took place.

    up to 6 months after the laparoscopy

Secondary Outcomes (5)

  • length of surgery

    intraoperative

  • length of hospital stay

    participants will be followed for the duration of hospital stay, an expected average of 2 days

  • complication rate

    during the surgery and until one month after the surgery.

  • Measure of efficacy of the treatment by questionnaire

    4 months and 6 months after the laparoscopy

  • Ovarian reserve

    4 months and 6 months after the laparoscopy

Study Arms (2)

study group - sclerotherapy

EXPERIMENTAL

Aspiration and Sclerotherapy of endometriomas.

Procedure: Aspiration and Sclerotherapy of endometriomas.Drug: Ethanol

control group - cystectomy

OTHER

cystectomy of endometriomas.

Procedure: cystectomy of endometriomas.

Interventions

Aspiration and Sclerotherapy of endometriomas.PROCEDURE

Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas

study group - sclerotherapy
cystectomy of endometriomas.PROCEDURE

cystectomy of endometriomas during laparoscopy

control group - cystectomy
EthanolDRUG
study group - sclerotherapy

Eligibility Criteria

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

You may qualify if:

  • women with endometrial cyst ≥ 4 cm.
  • candidates for elective laparoscopy due to endometriosis.
  • age 18-45 years

You may not qualify if:

  • endometrial cyst \< 4 cm.
  • an emergency surgery.
  • age \<18 or \>45
  • women with a history of tubal ovarian abscess (TOA).
  • high index of suspision for ovarian malignancy.
  • ethanol sensitivity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir medical center

Kfar Saba, Israel

Location

Related Publications (12)

  • 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

  • Suganuma N, Wakahara Y, Ishida D, Asano M, Kitagawa T, Katsumata Y, Moriwaki T, Furuhashi M. Pretreatment for ovarian endometrial cyst before in vitro fertilization. Gynecol Obstet Invest. 2002;54 Suppl 1:36-40; discussion 41-2. doi: 10.1159/000066293.

    PMID: 12441659BACKGROUND

  • Chapron C, Vercellini P, Barakat H, Vieira M, Dubuisson JB. Management of ovarian endometriomas. Hum Reprod Update. 2002 Nov-Dec;8(6):591-7. doi: 10.1093/humupd/8.6.591.

    PMID: 12498427BACKGROUND

  • Shaw RW. Treatment of endometriosis. Lancet. 1992 Nov 21;340(8830):1267-71. doi: 10.1016/0140-6736(92)92960-n. No abstract available.

    PMID: 1359330BACKGROUND

  • Busacca M, Chiaffarino F, Candiani M, Vignali M, Bertulessi C, Oggioni G, Parazzini F. Determinants of long-term clinically detected recurrence rates of deep, ovarian, and pelvic endometriosis. Am J Obstet Gynecol. 2006 Aug;195(2):426-32. doi: 10.1016/j.ajog.2006.01.078.

    PMID: 16890551BACKGROUND

  • Zanetta G, Lissoni A, Dalla Valle C, Trio D, Pittelli M, Rangoni G. Ultrasound-guided aspiration of endometriomas: possible applications and limitations. Fertil Steril. 1995 Oct;64(4):709-13. doi: 10.1016/s0015-0282(16)57843-1.

    PMID: 7672139BACKGROUND

  • 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

  • Kafali H, Yurtseven S, Atmaca F, Ozardali I. Management of non-neoplastic ovarian cysts with sclerotherapy. Int J Gynaecol Obstet. 2003 Apr;81(1):41-5. doi: 10.1016/s0020-7292(02)00401-0.

    PMID: 12676392BACKGROUND

  • Bret PM, Atri M, Guibaud L, Gillett P, Seymour RJ, Senterman MK. Ovarian cysts in postmenopausal women: preliminary results with transvaginal alcohol sclerosis. Work in progress. Radiology. 1992 Sep;184(3):661-3. doi: 10.1148/radiology.184.3.1509048.

    PMID: 1509048BACKGROUND

  • 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

  • Hsieh CL, Shiau CS, Lo LM, Hsieh TT, Chang MY. Effectiveness of ultrasound-guided aspiration and sclerotherapy with 95% ethanol for treatment of recurrent ovarian endometriomas. Fertil Steril. 2009 Jun;91(6):2709-13. doi: 10.1016/j.fertnstert.2008.03.056. Epub 2008 Jun 20.

    PMID: 18571165BACKGROUND

  • Takuma N, Sengoku K, Pan B, Wada K, Yamauchi T, Miyamoto T, Ohsumi D, Ishikawa M. Laparoscopic treatment of endometrioma-associated infertility and pregnancy outcome. Gynecol Obstet Invest. 2002;54 Suppl 1:30-4; discussion 34-5. doi: 10.1159/000066292.

    PMID: 12441658BACKGROUND

MeSH Terms

Conditions

Endometriosis

Interventions

Ethanol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Dana Josephy, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 7, 2015

First Posted

June 16, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

June 16, 2015

Record last verified: 2015-06

Locations

IL(1)