Endometrioma Ethanol Sclerotherapy - Prospective Cohort Study Protocol
1 other identifier
observational
120
1 country
1
Brief Summary
Ovarian endometriomas are cystic masses lined with endometrial tissue that contains fluid arising from a collection of menstrual debris. Ovarian endometriomas clinical manifestations includes pelvic pain, dysmenorrhea, dysfunctional uterine bleeding, and infertility. Endometriomas are most commonly treated either medically or by surgical excision. Ultrasonography (US)-guided aspiration and sclerotherapy is a new approach. Its mechanism of action is believed to be destruction of the inner epithelial lining, which is followed by inflammation and fibrosis, eventually resulting in regression of the cyst. The main advantage in this approach is the avoidance of collateral damage to the ovary.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 9, 2022
CompletedFirst Submitted
Initial submission to the registry
March 7, 2023
CompletedFirst Posted
Study publicly available on registry
May 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
May 14, 2025
May 1, 2025
5.4 years
March 7, 2023
May 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The effect of
ultrasound (US)-guided sclerotherapy for the treatment of ovarian endometrioma effect on ovarian function and fertility treatment outcome.
3 Years
Study Arms (1)
women with endometrioma size of 25-100 mm
Prospective cohort study including women with endometrioma size of 25-100 mm who will undergo ultrasound (US)-guided sclerotherapy. IVF treatment can be done about a month afterwards.
Interventions
ultrasound (US)-guided sclerotherapy for the treatment of ovarian endometrioma
Eligibility Criteria
A woman with endometrioma with a diameter of 25-100 mm who is intended for IVF treatment to achieve pregnancy or for medical preservation/by choice.
You may qualify if:
- A woman with endometrioma with a diameter of 25-100 mm
You may not qualify if:
- Other causes of infertility (sperm disorder, ovulation disorder, uterine disorder, mechanical factor, poor ovarian reserve)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hillel Yaffe Medical Center
Hadera, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Einat Shalom-Paz, Prof
Hillel Yaffe Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2023
First Posted
May 14, 2025
Study Start
August 9, 2022
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
May 14, 2025
Record last verified: 2025-05