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Clinical Trials in Turkey / NCT05962775
Recruiting Not applicable

Ethanol Sclerotherapy Prior to ART

NCT05962775 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2023-05-01
Last updated
2024-10-16

Condition(s) studied

EndometriomaInfertilitySclerotherapyARTIVF

Investigational drug(s) / intervention(s)

Ethanol Sclerotherapy for Endometrioma

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
40 Years
Healthy volunteers
Accepted
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 outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Başkent University Adana IVF Center Adana Turkey (Türkiye) Recruiting
Ankara University School of Medicine, Department of Obstetrics and Gynecology Ankara Turkey (Türkiye) Recruiting
Bahçeci IVF Clinic Istanbul Turkey (Türkiye) Recruiting

More Ankara University trials in Turkey

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05962775 on ClinicalTrials.gov ↗ ← All trials in Turkey