Endometrioma Ethanol Sclerotherapy - Prospective Cohort Study Protocol

NCT ID: NCT06971458

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-09
• Study Completion Date: 2027-12-31

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.

Detailed Description

Endometriosis is a disease of the female reproductive system in which cells similar to those in the endometrium grow outside the uterus. Endometriosis prevalence is estimated to be around 10%, and even higher among women with infertility.

Endometriosis can involve any pelvic organ and in rare cases it may also occur in other parts of the body.

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. Surgical excision is considered the standard therapy when pain is not controlled well by medication or when malignancy is being suspected. However, deterioration in the ovarian reserve after cystectomy is inevitable due to the removal of normal ovarian tissue adjacent to the endometrioma, and the possibility of excessive electrocoagulation for hemostasis.

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. There are still no guidelines suggesting US-guided sclerotherapy for endometrioma, although it has been used worldwide over the years since its introduction, and is reported to be an effective therapeutic option for endometriosis-associated pain and infertility. There are several reports of a higher oocyte number and higher pregnancy rate in IVF treatments after sclerotherapy in comparison with IVF after cystectomy. There is also a report of higher pregnancy rate in IVF treatments after sclerotherapy in comparison with leaving the endometrioma in-situ.

The procedure is done in an ambulatory arrangement under general anesthesia. Antibiotic prophylaxis with cefazolin 2g is administrated before beginning of the procedure. First step is (US)-guided aspiration of the endometrioma content. A sample of the aspirated content is sent to cytology test. Second, the cyst is flushed with normal saline. Third, the cyst is filled with 95% ethanol. The ethanol is suspended for 10-15 minutes inside the cyst capsule and then aspirated

Conditions

IVF; Endometrioma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Sclerotherapy

Intervention Type: PROCEDURE

ultrasound (US)-guided sclerotherapy for the treatment of ovarian endometrioma

Interventions

Sclerotherapy

ultrasound (US)-guided sclerotherapy for the treatment of ovarian endometrioma

Intervention Type: PROCEDURE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 41 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Einat Shalom-Paz, Prof

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical Center

Locations

Hillel Yaffe Medical Center

Hadera, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Einat Shalom-Paz, Prof

Role: CONTACT

EINATS@hymc.gov.il

+972-4-7744750

Osnat Palgi

Role: CONTACT

osnatp@hymc.gov.il

+972-4-7744602

Facility Contacts

Osnat Palgi

Role: primary

osnatp@hymc.gov.il

+972-4-7744602

Other Identifiers

0008-22-HYMC

Identifier Type: -

Identifier Source: org_study_id