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AzTrials

EndometriomaEASLETENCT02472873

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

A study testing Aspiration and Sclerotherapy of endometriomas., cystectomy of endometriomas. and Ethanol in people with Endometrioma and Endometriosis, run by Meir Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Endometrioma, Endometriosis
What is being tested?
Aspiration and Sclerotherapy of endometriomas., cystectomy of endometriomas. and Ethanol
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteIsrael
Study dates
Jun 2015to Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Meir medical center

    Kfar Saba

Other trials in Israel

About this study

Official title: Efficacy of Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas - a Prospective Case Control Study

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.

Read the detailed description

Women who are candidates for elective laparoscopy for the treatment of ovarian ensometriomas will be assigned to one of two groups - a) standard cystectomy treatment, b) aspiration and sclerotherapy using 95% ethanol. The women will be introduced with both operative options and they will choose which one they prefer. After an elaborate explanation about the study they will sign an informed consent form. the following data will be collected prior the operation: age, gravity \& parity, operative history, general medical history, the cyst size, AMH (Anti Mullerian Hormone), AFC (Antral Follicle Count), symptoms related to endometriosis (through a questionnaire), fertility history including any fertility treatment in the past and planned pregnancy after the operation.

The laparoscopy will take place in Meir Medical Center. in the study group the cyst content will be aspirated and flushed with normal saline. 95% sterile ethanol will be instilled into the cyst through a foley catheter. Ethanol will be left in the cyst for a maximum of 15 min then aspirated as completely as possible following normal saline flushing. In the control group we will follow the standard treatment which is cystectomy.

The women will be followed 4 and 6 months after the surgery.

Being tested
Aspiration and Sclerotherapy of endometriomas., cystectomy of endometriomas., Ethanol
Keywords
endometrioma, endometriosis, sclerotherapy, ethanol, aspiration, laparoscopy
Medical subject headings
Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aspiration and Sclerotherapy of endometriomas.Procedure or surgery

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

  • cystectomy of endometriomas.Procedure or surgery

    cystectomy of endometriomas during laparoscopy

  • EthanolDrug

Study groups in NCT02472873
Study groupRoleWhat they receive
study group - sclerotherapyExperimentalAspiration and Sclerotherapy of endometriomas.
Receives: Procedure: Aspiration and Sclerotherapy of endometriomas.; Drug: Ethanol
control group - cystectomyOthercystectomy of endometriomas.
Receives: Procedure: cystectomy of endometriomas.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 6 months after the laparoscopy

Secondary outcomes (5)

  1. length of surgery

    the time from insertion of the first trocar until closing of the abdominal wall.

    Measured: intraoperative

  2. length of hospital stay

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

  3. complication rate

    infection, excessive bleeding, injury to other abdominal organs

    Measured: during the surgery and until one month after the surgery.

  4. Measure of efficacy of the treatment by questionnaire

    Measured: 4 months and 6 months after the laparoscopy

  5. Ovarian reserve

    Anti mullerian hormone (AMH) and antral follicle count (AFC) measurement 4 months and 6 months after the laparoscopy

    Measured: 4 months and 6 months after the laparoscopy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionJun 2019 (estimated)
  4. Study completionJun 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02472873
Sponsor's protocol ID
0062-15
Acronym
EASLETE
Status last verified
Jun 2015
First submitted
7 Jun 2015
Last updated
16 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12270563

  • 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.

    PubMed 12441659

  • 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.

    PubMed 12498427

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

    PubMed 1359330

  • 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.

    PubMed 16890551

  • 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.

    PubMed 7672139

  • 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.

    PubMed 3283269

  • 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.

    PubMed 12676392

  • 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.

    PubMed 1509048

  • 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.

    PubMed 11146075

  • 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.

    PubMed 18571165

  • 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.

    PubMed 12441658

Questions about this trial

What is this clinical trial studying?

A study testing Aspiration and Sclerotherapy of endometriomas., cystectomy of endometriomas. and Ethanol in people with Endometrioma and Endometriosis, run by Meir Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

endometrioma recurrence rate (time frame: up to 6 months after the laparoscopy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02472873, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.

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