Ethanol Sclerotherapy Prior to ART

ConditionsEndometrioma Infertility Sclerotherapy ART IVF

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-40

SponsorAnkara University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

AMH>0.3 ng/ml

unilateral/bilateral endometrioma

Endometrioma diameter 40-100 mm

Disqualifiers

3 or more IVF/embryo transfer failure

Menstrual cycle abnormalities

Male Factor infertility

Presence of uterine fibroids

Trial design

Design model

Parallel

Treatments tested in this trial

Ethanol Sclerotherapy for Endometrioma
Procedure/Surgery
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.

Treatment groups

84 Participants

are divided into 2 treatment groups

Group A: ControlNo intervention 0 interventions

Group B: Ethanol sclerotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Cumulative live birth rate

live births following fresh and frozen-thaw transfer of all embryos unless pregnancy occurs

Time frame

18 months

Secondary outcomes

pain scores

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.

Time frame

3 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ankara University

Lead sponsor

Hacettepe University

Collaborator

Source ClinicalTrials.gov

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