START: Ethanol Sclerotherapy Prior to ART

Sponsor

Ankara University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05962775

Collaborator

Hacettepe University (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrioma Infertility Sclerotherapy ART IVF	Procedure: Ethanol Sclerotherapy for Endometrioma	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control In eligible patients allocated to control group, no interventions will be done before ART cycle.
Experimental: Ethanol sclerotherapy 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 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.

Arm

Intervention/Treatment

No Intervention: Control

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

Experimental: Ethanol sclerotherapy

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

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

pain scores [3 months]
Visual Analog Pain Scale scores related to dysmenorrhea, dyspareunia, and/or pelvic pain will be measured before and after procedure

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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