Hillel Yaffe Medical Center
Hadera, Israel
Location status: Recruiting
NCT Number: NCT06971458
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.
Interested in participating?
Request Info18 year–41 year
Female
Observational
Hadera, Israel
Location status: Recruiting
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
A woman with endometrioma with a diameter of 25-100 mm
Exclusion criteria
ultrasound (US)-guided sclerotherapy for the treatment of ovarian endometrioma
Time frame: 3 Years
ultrasound (US)-guided sclerotherapy for the treatment of ovarian endometrioma effect on ovarian function and fertility treatment outcome.
Contact information is provided by the study sponsor or research team.
Einat Shalom-Paz, Prof
CONTACT
Osnat Palgi
CONTACT
Hillel Yaffe Medical Center
Other Gov
Endometrioma Ethanol Sclerotherapy and Its Effect on Ovarian Function and Fertility Treatment Outcome - Prospective Cohort Study Protocol
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05962775
ART, Endometrioma
Adana, Turkey (Türkiye)
View Trial DetailsNCT04500743
Endometriosis, Female Urogenital Diseases
Minya, Egypt
View Trial DetailsNCT04306276
Endometriosis, Endometriosis Ovary
Genoa, Italy
View Trial DetailsNCT01826500
Endometriosis, Female Urogenital Diseases
Rennes, Britanny, France
View Trial Details