Clinical trial NCT06971458: Endometrioma Ethanol Sclerotherapy - Prospective Cohort Study Protocol
Official title: Endometrioma Ethanol Sclerotherapy and Its Effect on Ovarian Function and Fertility Treatment Outcome - Prospective Cohort Study Protocol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: IVF
Endometrioma
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2025-05-14
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

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)

Primary outcomes:
measure: The effect of
timeFrame: 3 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Einat Shalom-Paz, Prof
role: PRINCIPAL_INVESTIGATOR
References: