Ethanol sclerotherapy for treating ovarian endometriomas
Endometrioma Ethanol Sclerotherapy and Its Effect on Ovarian Function and Fertility Treatment Outcome - Prospective Cohort Study Protocol
This study tests if a treatment using ultrasound-guided ethanol can help women with painful ovarian cysts shrink them and reduce their symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 41 Years |
| Sex | Female |
| Sponsor | Hillel Yaffe Medical Center Government |
| Locations | 1 site (Hadera) |
| Trial ID | NCT06971458 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness of ultrasonography-guided ethanol sclerotherapy as a treatment for ovarian endometriomas, which are cystic masses associated with pelvic pain and infertility. The approach aims to destroy the inner epithelial lining of the cyst, leading to inflammation and fibrosis, ultimately resulting in cyst regression while minimizing damage to surrounding ovarian tissue. The study will include women with endometriomas measuring 25-100 mm in diameter and will exclude those with other infertility causes.
Who should consider this trial
Good fit: Ideal candidates for this study are women with ovarian endometriomas measuring between 25-100 mm.
Not a fit: Patients with infertility due to other causes, such as sperm disorders or uterine abnormalities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a less invasive option for women suffering from endometriomas, potentially improving fertility outcomes and reducing pain.
How similar studies have performed: While there are no established guidelines for this approach, the use of sclerotherapy for endometriomas is a novel method that has not been widely tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: A woman with endometrioma with a diameter of 25-100 mm Exclusion Criteria: * Other causes of infertility (sperm disorder, ovulation disorder, uterine disorder, mechanical factor, poor ovarian reserve)
Where this trial is running
Hadera
- Hillel Yaffe Medical Center — Hadera, Israel (Recruiting)
Study contacts
- Principal investigator: Einat Shalom-Paz, Prof — Hillel Yaffe Medical Center
- Study coordinator: Einat Shalom-Paz, Prof
- Email: EINATS@hymc.gov.il
- Phone: +972-4-7744750
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.