[Ultrasonically guided puncture of endometrial cysts--aspiration of contents and infusion of ethanol].
N Akamatsu, T Hirai, H Masaoka...
https://pubmed.ncbi.nlm.nih.gov/3283269Actively Recruiting
Led by Ankara University · Updated on 2024-10-16
84
Participants Needed
3
Research Sites
12 weeks
Total Duration
A
Ankara University
Lead Sponsor
H
Hacettepe University
Collaborating Sponsor
Researchers are investigating the effects of ethanol sclerotherapy before assisted reproductive technology (ART) cycles in infertile women with endometrioma. This randomized controlled trial aims to determine whether ethanol sclerotherapy impacts the cumulative live birth rate and other outcomes such as chronic pelvic pain, dysmenorrhea, complications during egg retrieval, response to ovarian stimulation, and pregnancy loss rates. The study focuses on patients with endometrioma sized 4 to 10 cm who are scheduled to undergo ART within two cycles. Participants will be randomly assigned to one of two groups. In the control group, patients will proceed to ART without any intervention before the cycle. In the treatment group, ethanol sclerotherapy will be performed 1 to 2 cycles before ART. This procedure involves aspirating the endometrioma cyst content, washing it with saline, injecting 96% ethanol for 10 minutes, and then aspirating the ethanol. Antibiotics will be given before the procedure to reduce infection risk. Throughout the study, participants will be monitored for outcomes such as the cumulative live birth rate over 18 months and pain scores over 3 months. Assessments include tracking the number of mature eggs retrieved, complications during procedures, and pregnancy loss rates. The study will also consider factors like ovarian reserve measured by anti-Mullerian hormone levels. Participant involvement includes treatment procedures, ART cycles, and follow-up for outcome measurements and safety monitoring.
CONDITIONS
Ethanol Sclerotherapy Prior to ART
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 ART cycles before treatment
Participants in the study group receive ethanol sclerotherapy to treat endometrioma 1-2 cycles before starting the assisted reproductive technology (ART) cycle. This involves aspirating the cyst content and injecting ethanol to treat the cyst.
1 to 2 procedure visits
Duration - 1 to 2 ART cycles
Participants undergo assisted reproductive technology (ART) cycles following ethanol sclerotherapy or without intervention in the control group.
Visits as part of ART treatment
Duration - Up to 18 months after ART cycles
Participants are followed for reproductive outcomes including live birth rate and pain scores after ART cycles.
Visits for outcome assessments up to 18 months
Total: 3 locations
1
Başkent University Adana IVF Center
Adana, Turkey (Türkiye)
Actively Recruiting
2
Ankara University School of Medicine, Department of Obstetrics and Gynecology
Ankara, Turkey (Türkiye), 06610
Actively Recruiting
3
Bahçeci IVF Clinic
Istanbul, Turkey (Türkiye)
Actively Recruiting
Y
Yavuz Emre Sukur
S
Sezcan Mumusoglu
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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