RecruitingNot ApplicableNCT05962775

Ethanol Sclerotherapy Prior to ART

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

Sponsor

Ankara University

Enrollment

84 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

Endometrioma Infertility ART IVF Sclerotherapy

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. 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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria3

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

Exclusion Criteria7

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

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Interventions

PROCEDUREEthanol 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.