Actively Recruiting
Endometrioma Ethanol Sclerotherapy and Its Effect on Ovarian Function and Fertility Treatment Outcome - Prospective Cohort Study Protocol
Led by Hillel Yaffe Medical Center · Updated on 2025-05-14
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the use of ultrasonography (US)-guided ethanol sclerotherapy for treating ovarian endometriomas, which are cystic masses caused by endometrial tissue collecting fluid. These cysts can cause pelvic pain, painful menstruation, irregular uterine bleeding, and infertility. Endometriomas are commonly treated with medication or surgery, but this study explores a less invasive approach that may avoid damage to the ovary. The study involves women with endometriomas sized between 25 and 100 mm who will undergo US-guided aspiration of the cyst fluid followed by sclerotherapy using 95% ethanol. The ethanol is left inside the cyst for 10 to 15 minutes and then removed. This procedure is done under general anesthesia with antibiotic protection given beforehand. After the procedure, some participants may undergo in vitro fertilization (IVF) about a month later to assess fertility outcomes. Participants will be monitored to evaluate the effects of sclerotherapy on ovarian function and fertility treatment results over three years. Researchers will collect samples for cytology testing and track outcomes related to ovarian reserve and pregnancy rates. The study aims to measure how this treatment impacts ovarian health and IVF success while avoiding the ovarian damage sometimes caused by surgery.
CONDITIONS
Brief Title
Endometrioma Ethanol Sclerotherapy - Prospective Cohort Study Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A woman with endometrioma with a diameter of 25-100 mm
- Female aged 18 to 41 years
You will not qualify if you...
- Other causes of infertility such as sperm disorder, ovulation disorder, uterine disorder, mechanical factor, or poor ovarian reserve
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo ultrasound (US)-guided sclerotherapy for the treatment of ovarian endometrioma. This is done in an ambulatory setting under general anesthesia, including aspiration, flushing, and ethanol sclerotherapy of the cyst.
1 procedure visit (in-person)
Duration - Up to 3 years
Participants are observed following the sclerotherapy procedure, including the possibility of IVF treatment about one month afterwards.
Follow-up visits as needed over 3 years
Trial Site Locations
Total: 1 location
1
Hillel Yaffe Medical Center
Hadera, Israel
Actively Recruiting
Research Team
E
Einat Shalom-Paz, Prof
O
Osnat Palgi
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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