Ethanol Sclerotherapy Prior to ART

Not Applicable

Recruiting

• Conditions: Endometrioma; Infertility; Sclerotherapy; ART; IVF
• Interventions: Procedure: Ethanol Sclerotherapy for Endometrioma

• Registration Number: NCT05962775
• Lead Sponsor: Ankara University

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. 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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-07-19
• Study First Submitted QC: 2023-07-19
• Study First Posted: 2023-07-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-13
• Last Update Posted: 2024-10-16
• Primary Completion: 2026-01-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cumulative live birth rate	18 months	live births following fresh and frozen-thaw transfer of all embryos unless pregnancy occurs

Secondary Outcome Measures

Name	Time	Method
pain scores	3 months	Visual Analog Pain Scale scores related to dysmenorrhea, dyspareunia, and/or pelvic pain will be measured before and after procedure. 0 is the lowest, 10 is the highest score. Higher the score means higher the pain.

Trial Locations

Locations (3)

Başkent University Adana IVF Center; 🇹🇷 Adana, Turkey

Bahçeci IVF Clinic; 🇹🇷 Istanbul, Turkey

Ankara University School of Medicine, Department of Obstetrics and Gynecology; 🇹🇷 Ankara, Turkey