Ethanol Sclerotherapy Prior to ART

NCT05962775 | Recruiting DMC

• 1 other identifier: AUTF
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this randomized controlled trial is to assess the impact of ethanol sclerotherapy on ART cycle outcomes. The main questions it aims to answer are:

1. 1.Does ethanol sclerotherapy before ART cycle has any impact on cumulative live birth rate in patients with endometrioma?
2. 2.Does ethanol sclerotherapy improve chronic pelvic pain, dysmenorrhea, complications during oocyte retrieval, response to ovarian stimulation (number of mature oocytes retrieved), and pregnancy loss rates?

Conditions

Endometrioma; Infertility; Sclerotherapy; ART; IVF

Keywords

endometrioma; ethanol sclerotherapy; assisted reproductive technology; in vitro fertilization; cumulative live birth rate

Outcome Measures

Primary Outcomes (1)

• Cumulative live birth rate

  live births following fresh and frozen-thaw transfer of all embryos unless pregnancy occurs

  18 months

Secondary Outcomes (1)

• pain scores

  3 months

Study Arms (2)

Control

NO INTERVENTION

In eligible patients allocated to control group, no interventions will be done before ART cycle.

Ethanol sclerotherapy

EXPERIMENTAL

In eligible patients allocated to study group, endometrioma/s will be aspirated and treated with ethanol for 10 minutes 1-2 cycles before ART.

Procedure: Ethanol Sclerotherapy for Endometrioma

Interventions

Ethanol Sclerotherapy for Endometrioma PROCEDURE

2 gr IV cefazolin sodium will be administered 30 minutes before the procedure. The endometrioma cyst content will be aspirated by a single lumen needle, and the total aspirated volume calculation will be done. The endometrioma will then be washed with saline until the color of the cyst content becomes clear. Then, 96% ethanol will be injected into the cyst. The volume of injected ethanol will be 60% of the first aspirated volume (maximum 100 ml). After 10 minutes all ethanol will be aspirated.

Ethanol sclerotherapy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• AMH\>0.3 ng/ml
• unilateral/bilateral endometrioma
• Endometrioma diameter 40-100 mm

You may not qualify if:

• or more IVF/embryo transfer failure
• Menstrual cycle abnormalities
• Male Factor infertility
• Presence of uterine fibroids
• Presence of hydrosalpinx
• Presence of uterine abnormalities
• Suspicion of malignancy according to International Ovarian Tumor Analysis criteria

Sponsors & Collaborators

• Ankara University: lead
• Hacettepe University: collaborator

Study Sites (3)

Başkent University Adana IVF Center

Adana, Turkey (Türkiye)

RECRUITING

Ankara University School of Medicine, Department of Obstetrics and Gynecology

Ankara, 06610, Turkey (Türkiye)

RECRUITING

Bahçeci IVF Clinic

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (18)

• 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: 3283269 BACKGROUND

• Alborzi S, Ravanbakhsh R, Parsanezhad ME, Alborzi M, Alborzi S, Dehbashi S. A comparison of follicular response of ovaries to ovulation induction after laparoscopic ovarian cystectomy or fenestration and coagulation versus normal ovaries in patients with endometrioma. Fertil Steril. 2007 Aug;88(2):507-9. doi: 10.1016/j.fertnstert.2006.11.134. Epub 2007 Apr 11.

  PMID: 17433319 BACKGROUND

• Benaglia L, Busnelli A, Biancardi R, Vegetti W, Reschini M, Vercellini P, Somigliana E. Oocyte retrieval difficulties in women with ovarian endometriomas. Reprod Biomed Online. 2018 Jul;37(1):77-84. doi: 10.1016/j.rbmo.2018.03.020. Epub 2018 Apr 13.

  PMID: 29759886 BACKGROUND

• 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.

  PMID: 19502358 BACKGROUND

• 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.

  PMID: 28579409 BACKGROUND

• Dunselman GA, Vermeulen N, Becker C, Calhaz-Jorge C, D'Hooghe T, De Bie B, Heikinheimo O, Horne AW, Kiesel L, Nap A, Prentice A, Saridogan E, Soriano D, Nelen W; European Society of Human Reproduction and Embryology. ESHRE guideline: management of women with endometriosis. Hum Reprod. 2014 Mar;29(3):400-12. doi: 10.1093/humrep/det457. Epub 2014 Jan 15.

  PMID: 24435778 BACKGROUND

• Garcia-Velasco JA, Somigliana E. Management of endometriomas in women requiring IVF: to touch or not to touch. Hum Reprod. 2009 Mar;24(3):496-501. doi: 10.1093/humrep/den398. Epub 2008 Dec 4.

  PMID: 19056774 BACKGROUND

• Hart RJ, Hickey M, Maouris P, Buckett W. Excisional surgery versus ablative surgery for ovarian endometriomata. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD004992. doi: 10.1002/14651858.CD004992.pub3.

  PMID: 18425908 BACKGROUND

• Horton J, Sterrenburg M, Lane S, Maheshwari A, Li TC, Cheong Y. Reproductive, obstetric, and perinatal outcomes of women with adenomyosis and endometriosis: a systematic review and meta-analysis. Hum Reprod Update. 2019 Sep 11;25(5):592-632. doi: 10.1093/humupd/dmz012.

  PMID: 31318420 BACKGROUND

• Meuleman C, Vandenabeele B, Fieuws S, Spiessens C, Timmerman D, D'Hooghe T. High prevalence of endometriosis in infertile women with normal ovulation and normospermic partners. Fertil Steril. 2009 Jul;92(1):68-74. doi: 10.1016/j.fertnstert.2008.04.056. Epub 2008 Aug 5.

  PMID: 18684448 BACKGROUND

• Miquel L, Preaubert L, Gnisci A, Netter A, Courbiere B, Agostini A, Pivano A. Transvaginal ethanol sclerotherapy for an endometrioma in 10 steps. Fertil Steril. 2021 Jan;115(1):259-260. doi: 10.1016/j.fertnstert.2020.08.1422. Epub 2020 Oct 8.

  PMID: 33039127 BACKGROUND

• Miquel L, Preaubert L, Gnisci A, Resseguier N, Pivano A, Perrin J, Courbiere B. Endometrioma ethanol sclerotherapy could increase IVF live birth rate in women with moderate-severe endometriosis. PLoS One. 2020 Sep 28;15(9):e0239846. doi: 10.1371/journal.pone.0239846. eCollection 2020.

  PMID: 32986747 BACKGROUND

• Roustan A, Perrin J, Debals-Gonthier M, Paulmyer-Lacroix O, Agostini A, Courbiere B. Surgical diminished ovarian reserve after endometrioma cystectomy versus idiopathic DOR: comparison of in vitro fertilization outcome. Hum Reprod. 2015 Apr;30(4):840-7. doi: 10.1093/humrep/dev029. Epub 2015 Mar 3.

  PMID: 25740883 BACKGROUND

• Rubod C, Jean Dit Gautier E, Yazbeck C. [Surgical management of endometrioma: Different alternatives in term of pain, fertility and recurrence. CNGOF-HAS Endometriosis Guidelines]. Gynecol Obstet Fertil Senol. 2018 Mar;46(3):278-289. doi: 10.1016/j.gofs.2018.02.013. Epub 2018 Mar 3. French.

  PMID: 29510964 BACKGROUND

• Somigliana E, Benaglia L, Paffoni A, Busnelli A, Vigano P, Vercellini P. Risks of conservative management in women with ovarian endometriomas undergoing IVF. Hum Reprod Update. 2015 Jul-Aug;21(4):486-99. doi: 10.1093/humupd/dmv012. Epub 2015 Mar 6.

  PMID: 25750209 BACKGROUND

• Sukur YE, Ozmen B, Yakistiran B, Atabekoglu CS, Berker B, Aytac R, Sonmezer M. Endometrioma surgery is associated with increased risk of subsequent assisted reproductive technology cycle cancellation; a retrospective cohort study. J Obstet Gynaecol. 2021 Feb;41(2):259-262. doi: 10.1080/01443615.2020.1754366. Epub 2020 Jun 4.

  PMID: 32496142 BACKGROUND

• 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: 19573300 BACKGROUND

• Yazbeck C, Koskas M, Cohen Scali S, Kahn V, Luton D, Madelenat P. [How I do... ethanol sclerotherapy for ovarian endometriomas]. Gynecol Obstet Fertil. 2012 Oct;40(10):620-2. doi: 10.1016/j.gyobfe.2012.07.029. Epub 2012 Sep 5. No abstract available. French.

  PMID: 22959083 BACKGROUND

MeSH Terms

Conditions

Endometriosis; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Batuhan Aslan

  Ankara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yavuz Emre Sukur

CONTACT

+905332409381; yesukur@gmail.com

Sezcan Mumusoglu

CONTACT

+905326404673; sezcanmumusoglu@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 19, 2023
• First Posted: July 27, 2023
• Study Start: May 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: April 1, 2026
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)