Ethanol Sclerotherapy Prior to ART

Официальное название

The Impact of Ethanol Sclerotherapy Before ART (Assisted Reproductive Technology) Cycle on Cumulative Live Birth Rate in Infertile Women With Endometrioma: A Randomized Controlled Trial

Обзор

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. Does ethanol sclerotherapy before ART cycle has any impact on cumulative live birth rate in patients with endometrioma? 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? Infertile patients with endometrioma between 4-10 cm who are scheduled for ART within 2 cycles will be randomized to ethanol sclerotherapy or no intervention.

Подробное описание

The effect of ethanol sclerotherapy before assisted reproductive technology (ART) cycle in patients with endometrioma on reproductive outcomes will be investigated. While endometrioma may result in technical difficulties in the ART process, the superiority of ethanol sclerotherapy has yet to be examined before the ART procedure in randomized controlled studies and meta-analyses. The negative effect of ethanol sclerotherapy on ovarian reserve was found to be less than other existing interventions such as cyst stripping. However, randomized controlled studies did not determine its direct effect on ART outcome. Our current study aimed to assess the effect of ethanol sclerotherapy on ART outcomes.

Infertile patients aged 18-40 years with at least one endometrioma 4-10 cm and scheduled for ART will be included in the study. Patients with any untreated thyroid dysfunction or additional disease, such as hyperprolactinemia, those who did not accept the study information and consent, and patients younger than 18 or older than 40 will not be included. Those who underwent surgery for endometrioma within 3 months before ART will be excluded. In addition, patients with an anti-mullerian hormone value below 0.3 ng/ml will not be included in the study.

Вмешательства

• Процедура Ethanol Sclerotherapy for Endometrioma
  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.

Первичные конечные точки

• Cumulative live birth rate [Срок оценки: 18 months]

Вторичные конечные точки (1)

• pain scores [Срок оценки: 3 months]

Критерии участия

Критерии включения

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

Критерии исключения

• 3 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 3 центра

• Başkent University Adana IVF Center — Adana
• Ankara University School of Medicine, Department of Obstetrics and Gynecology — Ankara
• Bahçeci IVF Clinic — Istanbul

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT05962775 · AUTF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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