Ethanol Sclerotherapy Prior to ART

Study Overview
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Brief Summary
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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: Does ethanol sclerotherapy before ART cycle has any impact on cumulative live birth rate in patients with endometrioma? 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
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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.

Official Title
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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

Conditions
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Endometrioma, Infertility, Sclerotherapy, ART, IVF

Intervention / Treatment
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* Procedure: Ethanol Sclerotherapy for Endometrioma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>In eligible patients allocated to control group, no interventions will be done before ART cycle. | |
| Experimental: Ethanol sclerotherapy<br>In eligible patients allocated to study group, endometrioma/s will be aspirated and treated with ethanol for 10 minutes 1-2 cycles before ART. | Procedure: Ethanol Sclerotherapy for Endometrioma<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative live birth rate | live births following fresh and frozen-thaw transfer of all embryos unless pregnancy occurs | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain scores | Visual Analog Pain Scale scores related to dysmenorrhea, dyspareunia, and/or pelvic pain will be measured before and after procedure | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endometrioma, ethanol sclerotherapy, assisted reproductive technology, in vitro fertilization, cumulative live birth rate