Clinical trial NCT05962775: Ethanol Sclerotherapy Prior to ART
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometrioma
Infertility
Sclerotherapy
ART
IVF
Keywords: endometrioma
ethanol sclerotherapy
assisted reproductive technology
in vitro fertilization
cumulative live birth rate
Lead sponsor: Ankara University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2023-07-27
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative live birth rate
timeFrame: 18 months
Secondary outcomes:
measure: pain scores
timeFrame: 3 months
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Başkent University Adana IVF Center
city: Ankara
country: Turkey
facility: Ankara University School of Medicine, Department of Obstetrics and Gynecology
city: Istanbul
country: Turkey
facility: Bahçeci IVF Clinic
Study officials:
affiliation: Ankara University
name: Batuhan Aslan
role: PRINCIPAL_INVESTIGATOR
References:
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