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Ethanol Sclerotherapy Prior to ART

Study acronym: START
StatusRecruiting
PhaseNot applicable
Started2023-05-01
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 16, 2024 (before its estimated January 1, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2024-10-13
minor
Study Status, Outcome Measures, Contacts/Locations v1
Primary completion date2025-01-01→2026-01-01
Completion date2025-04-01→2026-04-01
Study sites1→3
Secondary endpointsdetails revised at 1 of 1 entry
2023-07-19
minor
Original filing
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.
Trial Details
NCT Number NCT05962775
Lead Sponsor Ankara University
Collaborators: Hacettepe University
Conditions Endometrioma, Infertility, Sclerotherapy, ART, IVF
Enrollment 84 participants
Start Date 2023-05-01
Primary Completion 2026-01-01 (estimated)
Study Completion 2026-04-01 (estimated)
Updated on ClinicalTrials.gov 2024-10-16