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Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy

RecruitingNAAges 18 Years - 40 YearsFemaleErbe Elektromedizin GmbH
NCT07065214 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The study is a prospective, monocentric, randomized controlled, two-armed, pilot-study conducted at Department for Women's Health, Tuebingen, Germany. In this Post Market Study it will be determined whether and to what extent the two surgical procedures for ovarian endometrioma treatment (standard cystectomy versus APC) may affect the ovarian reserve by comparing changes in serum AMH levels after treatment. Seventy-two (72) patients who meet all eligibility criteria will undergo surgical procedure. The patients will be randomized into the group with standard cystectomy treatment or with APC treatment. Per group n=36 patients will be treated i.e., 1:1 randomization. A pre-specified primary endpoint analysis is planned after the last patient has undergo Visit 4 (Follow-up after 6 months) to analyze the primary endpoint. Screening takes place during the first visit (V1). During the seco

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📋 Eligibility rules (as published)
Inclusion Criteria: * Indication for surgical endometrioma treatment according to patient symptoms * Signed informed consent Exclusion Criteria: * Expected lack of patient compliance or inability of the patient to understand the purpose of the clinical trial * Prior procedures at the ovaries * Recurrent endometrioma (patients with recurrent endometriosis outside of the ovar, e.g. peritoneal endometriosis lesions can be included) * Pregnant or breastfeeding patients * Participation in any other clinical study that could affect the AMH level or pregnancy
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What it tests

  • APC
  • Lap bipolar forceps
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Where

1 site
Department for Women's Health
Tübingen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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