Ethanol Sclerotherapy Prior to ART (START)

Ankara University

Status: Enrolling

Conditions: IVF; Infertility; Sclerotherapy; ART; Endometrioma

Treatments: Procedure: Ethanol Sclerotherapy for Endometrioma

Study type: Interventional

Funder types: Other

Identifiers

NCT05962775

AUTF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Control

No Intervention group

Description:

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

Ethanol sclerotherapy

Experimental group

Description:

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

Treatment:

Procedure: Ethanol Sclerotherapy for Endometrioma