Endometrioma Ethanol Sclerotherapy - Prospective Cohort Study Protocol
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-41
SponsorHillel Yaffe Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Other causes of infertility (sperm disorder, ovulation disorder, uterine disorder, mechanical factor, poor ovarian reserve)
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Sclerotherapy
Procedure/Surgeryultrasound (US)-guided sclerotherapy for the treatment of ovarian endometrioma
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: women with endometrioma size of 25-100 mm1 intervention
Trial outcomes
Primary outcomes
1
The effect of
ultrasound (US)-guided sclerotherapy for the treatment of ovarian endometrioma effect on ovarian function and fertility treatment outcome.
Time frame
3 YearsSponsors and contacts
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Source ClinicalTrials.gov